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A chance to stop and breathe: participants’ experiences in the North American Opiate Medication Initiative… Oviedo-Joekes, Eugenia; Marchand, Kirsten; Lock, Kurt; Chettiar, Jill; Marsh, David C; Brissette, Suzanne; Anis, Aslam H; Schechter, Martin T Sep 29, 2014

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RESEARCHA chance to stop and breaAc1,Opioid dependence is a chronic, relapsing disease that abstinence-based treatments, with less than 30 percentOviedo-Joekes et al. Addiction Science & Clinical Practice 2014, 9:21http://www.ascpjournal.org/content/9/1/21prescribed heroin (i.e., diacetylmorphine, [DAM]) is anEast Mall, Vancouver, BC V6T 1Z3, CanadaFull list of author information is available at the end of the articlecan be fatal if untreated [1]. Abstinence-based therapies,a first-line treatment choice in many countries, have beenshown to successfully treat patients who have stable hous-ing, family support, and personal motivation (e.g., readi-ness for change) [2]. However, the marginalization thatoften accompanies long-term opioid dependence [3] isof patients remaining abstinent after one year [4]. Opioidsubstitution-based therapies, mainly oral methadone main-tenance treatment (MMT), are considered the most effect-ive options for the treatment of opioid dependence [2].Although MMT is effective for many patients [5,6], itis estimated that 15–25 percent of the most severely af-fected individuals with opioid dependence are not reachedor retained by MMT [7,8]. These individuals do not stayin MMT for very long, or they continue to use illicitopioids while in treatment [9,10]. Studies in Europe andCanada have demonstrated that supervised, medically* Correspondence: eugenia@cheos.ubc.ca1Centre for Health Evaluation & Outcome Sciences, Providence Health Care,St. Paul’s Hospital, 575- 1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada2School of Population and Public Health, University of British Columbia, 2206BackgroundAbstractBackground: The North American Opiate Medication Initiative (NAOMI) clinical trial compared the effectiveness ofinjectable diacetylmorphine (DAM) or hydromorphone (HDM) to oral methadone maintenance treatment (MMT).This study aimed to determine participants’ perceptions of treatment delivered in NAOMI.Methods: A qualitative sub-study was conducted with 29 participants (12 female): 18 (62.1%) received injectableDAM or HDM and 11 (37.9%) received MMT. A phenomenological theoretical framework was used. Semi-structuredinterviews were audio-recorded and transcribed verbatim. A thematic analysis was used over successive phases andwas driven by the semantic meanings of the data.Results: Participants receiving injectable medications suggested that the supervised delivery model was stringentbut provided valuable stability to their lives. Females discussed the adjustment required for the clinical setting,while males focused on the challenging clinic schedule and its impact on employment abilities. Participantsreceiving MMT described disappointment with being randomized to this treatment; however, positive aspects,including the quick titration time and availability of auxiliary services, were also discussed.Conclusion: Treatment with injectable DAM (or HDM) is preferred by participants and considered effective inreducing the burden of opioid dependency. Engaging patients in research regarding their perceptions of treatmentprovides a comprehensive assessment of treatment needs and barriers.Clinical trial registration: NCT00175357Keywords: Opioid dependency, Diacetylmorphine, Injectable, Oral methadone, Opioid maintenance treatment,Qualitative methodsassociated with a decrease in the effectiveness ofexperiences in the NorthMedication Initiative cliniEugenia Oviedo-Joekes1,2*, Kirsten Marchand1,2, Kurt LockAslam H Anis1,2 and Martin T Schechter1,2© 2014 Oviedo-Joekes et al.; licensee BioMedCreative Commons Attribution License (http:/distribution, and reproduction in any mediumDomain Dedication waiver (http://creativecomarticle, unless otherwise stated.Open Accessthe: participants’merican Opiateal trialJill Chettiar2, David C Marsh4,5, Suzanne Brissette3,Central Ltd. This is an Open Access article distributed under the terms of the/creativecommons.org/licenses/by/4.0), which permits unrestricted use,, provided the original work is properly credited. The Creative Commons Publicmons.org/publicdomain/zero/1.0/) applies to the data made available in thisOviedo-Joekes et al. Addiction Science & Clinical Practice 2014, 9:21 Page 2 of 10http://www.ascpjournal.org/content/9/1/21effective alternative for long-term opioid-dependent indi-viduals not benefitting sufficiently from available treat-ments [11]. The clinical trial conducted in Canada—theNorth American Opiate Medication Initiative (NAOMI)—demonstrated the effectiveness of the supervised modelof medically prescribed injectable DAM compared tooral methadone [12]. Participants randomized to inject-able treatments in this study achieved a better clinical re-sponse and higher retention to treatment at 12 months,compared to those randomized to oral treatment [12].Under this model, DAM is dispensed and self-administered by injection (or swallowed or inhaled insome clinics) under supervision in specially designedclinics. The rationale behind this model is that by pro-viding pharmaceutical-grade heroin in the presence ofhealth care providers, individuals not benefitting fromother treatments are more likely to be attracted andretained in treatment. They are protected from com-mon harms (e.g., fatal overdose and infectious diseasetransmission), since the dose and purity are controlledon site. This treatment also provides an opportunity toreduce illegal activities often arising from heroin ad-diction, by delivering medical and psychosocial sup-port services as well.Since the medication must be delivered on clinicpremises (i.e., no ‘take-home’ doses), participants attendthe clinic at least twice daily and undergo pre-intake(15 minutes) and post-intake assessments (30 minutes).Thus, providing injectable DAM might be a very demand-ing model for patients and could affect compliance. Moregenerally, patient adherence to life-saving treatment forconditions such as diabetes, even when they can take themedications with them, has an average nonadherencerate of 24.8 percent [13]. A social researcher on addic-tions has criticized this aspect of the supervised modeland suggested that qualitative research is needed to helpunderstand how and why heroin prescription works soeffectively [14]. These questions reinforce the need to in-clude an evaluation of the intervention’s process and out-comes by the patients themselves to guide clinical decisions,as part of a patient-centered model of care [15-17].Few studies have explored patient perceptions of inject-able DAM treatment using structured interviews, satis-faction measures [18,19], and qualitative data [18-22]. Aqualitative study with 21 participants and family takingpart in the Andalusian clinical trial explored the per-ceived impact of medically prescribed DAM adminis-tered under supervision. The study described a changein participants’ perceptions and perceived significanceof the substance (from illicit drug to a medication) andexplored improvements in the workplace, family rela-tions, and physical and mental health [20]. A study con-ducted in the Netherlands provided qualitative datafrom 24 participants who discussed the positive impactof having a reliable supply of DAM in improving theirdaily lives by reducing or discontinuing their involve-ment in illicit and street-based activities (e.g., drug deal-ing, hustling, and sex work) [21].While we assessed satisfaction with injectable and oraltreatments among NAOMI trial participants in a priorstudy [18], the questions regarding why the injectablegroup was more satisfied or why participants perceivedthe treatment to be effective remained unanswered. Theaim of the present study was to further explore partici-pants’ perceptions of the treatments delivered during thetrial in order to improve our understanding of the effect-iveness of these treatments and the model of care.MethodsThe NAOMI studyNAOMI was an open-label, phase III randomized con-trolled trial (RCT) that compared supervised injectableDAM and oral methadone in the treatment of long-termopioid dependence. The study was conducted in Vancouverand Montreal, Canada, between 2005 and 2008. Partici-pants were aged 25 or older, with at least 5 years of opioiddependence, current daily injection of illicit opioids, aminimum of two previous treatments for opioid depend-ence, including at least one opioid substitution treatment(OST) attempt, and no enrollment in OST within theprior 6 months. A full description and discussion of theparticipants’ profiles, study design, methodology, andmain results have been published elsewhere [12,23,24].Briefly, a total of 251 individuals were randomized to re-ceive oral methadone (n = 111), injectable DAM (n = 115),or injectable hydromorphone (HDM) (n = 25); the lattertwo on a double-blind basis. Participants administered theinjectable medications up to three times daily under thesupervision of clinic staff, and oral methadone was dis-pensed daily. Trial treatments were provided for 12 months,with an additional 3-month period to taper and transitionto other treatment modalities (primarily methadone). Par-ticipants met with their study physician at least once permonth for reviewing and discussing their medication. Par-ticipants had access on site to a comprehensive range ofpsychosocial and other primary care services, includingreferral to specialists and treatment for concurrent dis-orders. The procedures followed in the trial were in ac-cordance with the Helsinki declaration [25].NAOMI Participants’ experiences studyStudy designThe NAOMI participants’ experiences study was a quali-tative sub-study that aimed to understand the impact ofthe NAOMI trial on participants’ lives. A phenomeno-logical theoretical framework was chosen [26]. This studydesign was most appropriate for providing a description ofthe meaning and significance of participants’ prior lifetimeOviedo-Joekes et al. Addiction Science & Clinical Practice 2014, 9:21 Page 3 of 10http://www.ascpjournal.org/content/9/1/21experiences and appraisals of the treatments received dur-ing the clinical trial [26,27]. Participants eligible for thisqualitative sub-study were beyond the 12-month NAOMItreatment period (to avoid interference with the RCT’sprimary outcome measures at the Vancouver site).Participants were selected through stratified probability-based sampling. Stratum included male and female gen-der, Aboriginal and non-Aboriginal ethnicity, and oral andinjectable treatment groups. Although less commonlyused in qualitative research [28], the stratified probability-based sampling was most appropriate to ensure that anonbiased and representative sample of participantswas included, improving credibility [29]. A total of 32participants were randomly selected, representing thestratum defined above. This sample size was directedby the sub-study’s research questions and goal forrepresentativeness.Data collection procedureThe University of British Columbia/Providence HealthCare Research Ethics Board approved the study, and allparticipants provided written informed consent. Semi-structured qualitative interviews were conducted by re-search staff, independent of the clinical team, betweenFebruary and September 2008. The study coordinator(JC) invited participants and explained the aims of thequalitative sub-study. Participants received monetary com-pensation for their time.Interviews were held one time only with consentingparticipants at the NAOMI research office, with eitherthe parent study coordinator (JC) or the second inter-viewer (parent study research staff ). Both interviewerswere female and were experienced with the study popu-lation in general. By the start of this qualitative study,the interviewers had met with participants several timesbefore (every 3 months) to conduct follow-up researchinterviews for the parent trial that had started 3 yearsprior. Therefore, the interviewers had a contextual graspof the participants’ lives, and participants were familiarwith them. The research interviewers for the sub-studyreceived additional training on conducting semistruc-tured interviews as well as collecting data on the topicsincluded in the topic guide.A semistructured topic guide was used with an open-ended questioning approach. Topics included: drug usehistory and prior addiction treatment, situation beforeNAOMI, expectations of NAOMI, situation during NA-OMI, situation after NAOMI, and general perceptions ofthe NAOMI experience. When necessary, interviewersrepeated or rephrased questions to ensure that the topicswere covered; prompting was not used. Interviews lastedbetween 45 minutes and 2 hours. All interviews wereaudio-recorded and transcribed verbatim by an inde-pendent contractor.The parent study research coordinator and study in-vestigators (EOJ, MTS) met regularly during the datacollection phase to review and discuss the data collected.Upon completing 29 interviews, it was agreed by theteam that no new information was being gathered fromthe interviews and across each stratum.Data analysisAn inductive thematic analysis approach was used. Thethematic framework established by the researchers (EOJ,KM, DCM, MTS) was semantic and driven by the expli-cit meanings of the data [30]. This framework was orga-nized according to the main topics of the semistructuredinterviews. Data analysis was led by two of the authors(EOJ, KM) over successive phases. All coding and ana-lysis was done using NVivo software for qualitative dataanalysis [31].In the first phase, prior to any coding taking place,EOJ and KM first read each transcript to familiarizethemselves with the data. During the second phase, ini-tial ‘free’ codes were created based on semantic content.The lead researchers reviewed the initial free codes to-gether and created the following major themes duringthe third phase: a) reasons for participating in NAOMI;b) perceived impact of NAOMI treatment; c) percep-tions of the delivery of NAOMI treatment; d) recom-mendations; and e) experiences with ending NAOMI.Further review and refinement of the data was done inthe next phase of analysis. The content of the major themeswas reviewed; minor themes were identified based onpredominating patterns [32].After this phase, the researchers met to review prelim-inary thematic maps to refine and define themes for theobjectives of the present paper. During the analysis,comments were compared by gender (male and female),ethnicity (Aboriginal and non-Aboriginal), and treatmentcharacteristics (treatment arm, retention, and response).These characteristics were also used to identify partici-pants’ quotes.ResultsParticipants’ characteristics were representative of theparent clinical trial (Vancouver) sample [23]: 12 (41.4%)female and 17 (58.6%) male, Aboriginal ethnicity (27.6%),and average age of 44. A total of 14 participants (48.3%)received DAM, 4 (13.8%) received HDM, and 11 (37.9%)received oral MMT. Nineteen (65.5%) participants wereconsidered responders, and 25 (86.2%) were retained intreatment.Reasons for participating in NAOMIParticipants in both treatment arms entered NAOMIwith the hope that they would be randomized to injectabletreatments. Their reasons for preferring the injectableOviedo-Joekes et al. Addiction Science & Clinical Practice 2014, 9:21 Page 4 of 10http://www.ascpjournal.org/content/9/1/21But I didn’t have any, uh physical need to, to doheroin, outside of the programme. I didn’t, there wasenough dosage for me to uh, as long as I made thesessions, I didn’t need. [male non-Aboriginal partici-pant, age 50, DAM, responder, retained]Some of these participants, including one oral partici-pant, also said that they stopped using street heroin forthe entire time they were receiving study treatments.Those receiving injectable treatment expressed their lackof physical need or a desire to engage in ‘the hustle’ toobtain illicit heroin.I didn’t have to steal. I didn’t have to rob people. Ididn’t have to do things like that. My drugs were takentreatment varied, but were rooted in their prior experi-ences with other addiction treatments, mainly oral metha-done. Some participants described wishing to be part ofNAOMI to obtain “free heroin,” in the context of not hav-ing to hustle for a period of time. Others expected thatNAOMI would alleviate financial distress, provide stabil-ity, reduce involvement in sex work, and assist them withimproving their health and social situation.It wasn’t about gettin’ high for me. It was about gettinga life… That’s why I had went in…It was about notbeing sick. And, taking away that obsession…I wish Iwas still in it. I do. [female non-Aboriginal participant,age 50, DAM, nonresponder, retained]I could not manage, my pain, uh, when I first heardabout it [NAOMI]. I was, I was in, let’s say, [sigh]medium, or, or, mild chronic pain. If, if, I did have around-the-clock pain, which happened quite often, itwould uh be kind of low level and could be treatedwith drugs. But I just, [pause] I have a hard time stay-ing on methadone. It doesn’t seem to do anything forme and it doesn’t, doesn’t help the pain. Doesn’t, souh, yeah, so that’s, that, I’ve tried it a number of times.And it just doesn’t seem to work for me. So I was hopingthat I would get randomized to be heroin…. And ofcourse I didn’t. [male non-Aboriginal participant, age40, MMT, nonresponder, not retained]Perceived impact of NAOMI treatmentIllicit drug useParticipants in both treatment arms (mainly injectableparticipants) described a significant reduction in illicit heroinuse during NAOMI. Participants reflected that the reductionin heroin use was due to the quality of the medication andthe consistency of the dose received in the clinic.care of. [male non-Aboriginal participant, age 40,HDM, responder, retained]common illicit substance discussed by participants. Dur-ing NAOMI, the majority of participants (mostly thosereceiving injectable treatment) indicated experiencing eithera decrease or no change to their crack cocaine use. Reasonsfor reducing crack cocaine use varied; many participantsstated they were ‘tired, sick of it, realized what life was likebefore they started doing drugs;’ one participant (DAM fe-male, nonresponder, retained) stated that she reducedcrack cocaine use because she was not engaging in sexwork as often as before NAOMI.A few participants reported an increase in crack cocaine,and their discussions about this were more elaborate thanthose who described no change or a reduction in crack co-caine use. This increase was described by male partici-pants only, regardless of randomization arm, response, orretention to NAOMI treatment. Participants associatedtheir increased crack cocaine use with having more freed-up funds and the ‘engrained’ lifestyle associated with dailydrug use. Other aspects of participants lives, such as theenvironment in which participants lived, their relation-ships, and their sources of income (i.e., drug dealing), weredescribed as challenges to completely stopping illicit druguse.Participant: And I just, you know, the financial, uh,freedom from having to buy heroin every day. Like youknown more money in my pocket and, unfortunately,rather than spend it um more um, sane fashion. I gotto uh, a lot of it went to uh, crack and cocaine.Interviewer: Right. So, do you think? How, how couldthat be any different? Really, how, could NAOMI haveaccommodated that or other treatment programmes inthe future?Participant: Um, it’s not easy. If it wasn’t in theneighbourhood, you know. [male non-Aboriginal par-ticipant, age 50, DAM, responder, retained]Illicit activitiesPrior to NAOMI treatment, participants discussed theiramount, the times I did heroin during the wholeNAOMI thing. [female Aboriginal participant, age 50,DAM, responder, retained]In addition to heroin, crack cocaine was the mostFew described occasional use of street heroin, mostlydue to continued use of ‘speedballs’ (i.e., injection ofcocaine and heroin) or simply due to curiosity.I smoked rock [crack cocaine] every day. And, but uh,heroin I did it, I bet you I could count on one hand thehistories of engaging in drug dealing, petty theft, and sexwork (female participants only) as a means of supportingOviedo-Joekes et al. Addiction Science & Clinical Practice 2014, 9:21 Page 5 of 10http://www.ascpjournal.org/content/9/1/21to be around me I suppose. [male non-Aboriginalparticipant, age 40, MMT, responder, retained]HealthAt initiation to NAOMI, participants described havingboth physical (i.e., infections, respiratory and dental prob-lems) and mental health conditions (i.e., anxiety, depres-sion, and suicidal ideation). Participants also describedsuffering from chronic physical pain (e.g., arthritis, head-illicit drug use. Only those receiving injectable treatmentindicated no longer engaging in these activities, giventhe provision of treatments in NAOMI.I didn’t have to steal. I didn’t have to rob people. Ididn’t have to do things like that. My drugs were takencare of. [male non-Aboriginal participant, age 40,HDM, responder, retained]It got me out of the sex trade. The survival sex trade.[female non-Aboriginal participant, age 50, DAM,nonresponder, retained]HousingHousing situations varied considerably during the study.Some participants said they were living in the same placefor years, others (mostly females) acquired housing dur-ing NAOMI with the help of study staff, and two werehomeless at the time of the interview (both nonre-sponders). Participants described how difficult it was toacquire a secure place to live, expressing that they couldnot afford decent places and needed to accept poor condi-tions in order to have a place to live. Participants per-ceived their drug use as a barrier to housing and believedlack of housing was a barrier to work. Participants alsowere not welcome at family or friends’ homes. Most ofthose who were homeless for any period of time in theirlife indicated that when they were clean, they found aplace to live (although the conditions were not always verygood due to the lack of affordable and liveable places).I was only homeless, for I don’t know, 3 months orsomething like that. I mean technically I’m homelessright now, but I, I haven’t actually wound up on thestreets, you know. I got places to stay. And mean that’sthe thing. So when I went on the methadone, the needfor money isn’t as desperate. So um, I’m a little moretolerable to be around, like I’m welcome at friend’shouses and, to be at my dad’s house and stuff, becauseI’m, you know. [pause] They’re not worried that I’m allof a sudden start, [pause] start directly into, intoopiate withdrawal. And, crying, begging, for money.[chuckle] kind of like that, right? so. It’s more relaxingaches, and injury-related pain) and emphasized that thiswas one of the reasons for using illicit opioids and forseeking NAOMI treatment. Regardless of treatment arm,response, and retention, participants experiencing mentaland physical health problems discussed how NAOMI’shealth care staff provided prescriptions for bipolar dis-order and antiretroviral medications, as well as referralsfor acute and chronic conditions, such as arthritis, infec-tions, and skin conditions.And my health got pretty good too…Well, I’m HIV so, my,uh, viral load went down. They [NAOMI doctors] were[inaudible] I guess, yeah. I like ‘em. Well, some of the timeI went in there with injuries, so, so they took care of thatwhile I was there, you know? They knew about addictionI guess, so, that was handy, yeah. [male Aboriginalparticipant, age 40, DAM, responder, retained]Overall impact of NAOMIOverall, participants described a positive impact of thestudy on their lives. There were only two negative com-ments about the impact of NAOMI: randomization forthose assigned to oral and ending the study treatmentfor those receiving injectable (described below in theEnding NAOMI section). Participants in the oral grouparticulated their disappointment with the outcome ofthe randomization using expressions such as “disap-pointed, devastated, bitter, went violent, wasn’t excited,like a big bomb had dropped, I cried.” Some decided togive oral methadone another try right away; others leftand eventually returned to treatment days or weeks later.I came back about a month later and decided to go onthe methadone. […] Yeah the whole world just fell outfrom beneath me when they said the word methadone.[male, non-Aboriginal participant, age 40, MMT,responder, retained]Participants in both treatment arms (including nonre-sponders) indicated that the treatments provided themwith stability, improved their sense of self-worth, strength-ened their personal and community relationships, andallowed them to reflect positively on their future.And what the NAOMI project did for me was…let merealize what my life was before I started doing drugsand had to spend all my money on drugs and all myfree time, on getting money for drugs. And actuallymade me realize like the other parts of my life, that Ihad before, that I basically forgot about in the manyyears that I was doing heroin. And right now, to thisday, I don’t do, any injection drugs at all…I feel a lotbetter about myself too, like I have self-worth again.And when I was an addict, doin’ dope, fuck I just, feltdismal about myself. [male non-Aboriginal participant,age 40, DAM, responder, retained]Oviedo-Joekes et al. Addiction Science & Clinical Practice 2014, 9:21 Page 6 of 10http://www.ascpjournal.org/content/9/1/21Perceptions of treatment in NAOMIInteractions with health care providersA common theme among participants in both treatmentarms was their interactions with health care staff at thestudy clinic. Few participants described a negative inter-action with health care staff. Participants were more de-tailed during discussions about their interactions withthe physicians, but spoke positively about their generalinteractions with health care staff. They described re-ceiving care that was respectful, nonjudgmental, honest,and felt the staff listened, really cared, understood, andwere always there to answer a question. The staff ’s experi-ence and familiarity with the participants was beneficialbecause staff were able to be proactive on addressing thevarious needs of participants. For example, participantsdiscussed how the social workers helped address housingand disability support needs.When making comparisons between the quality of carereceived at the study clinic with prior experiences incommunity-based centers, participants in both treat-ment arms emphasized their preference for the care atNAOMI clinics because the physicians were more awareof their needs, and they could be more open about ex-pressing these needs.Uh actually yeah he referred me to um to um what doyou call this? Um bone specialist…What do you callthis? Uh rheumatologist. He hooked me up with myrheumatologist. Um at one point I had skin problem.He got me an appointment with a skin specialist. Imean he takes good care of me. And he explained tome everything. He’ll turn his computer screen if I don’tunderstand something and explain it to me. He, he’svery good. I never, I never ran into a doctor like thatbefore in my life. [male non-Aboriginal participant,age 40, MMT, nonresponder, retained]Methadone maintenance treatmentParticipants receiving oral treatment indicated they pre-ferred the delivery of MMT at NAOMI clinics becausethe services and staff were more easily accessible (i.e., nowait times, pharmacy on site). A few participants alsoexpressed their preference for NAOMI’s titration protocol,stating that the physicians increased doses in a mannerthat was appropriate for the participant, allowing them toreach a more stable and comfortable dose quickly. Partici-pants suggested that being able to reach more satisfactorydoses and having a role in this decision was critical at thebeginning of treatment, as it reduced withdrawal symp-toms and illicit heroin use.I think the main thing is…Dr. XX put me up to, highenough dose. Where I said before, I think I was on 80before when I was at this other clinic. But I mean itIn light of these positive experiences, the main recom-mendation for improving oral treatment in NAOMI wasto extend the operating hours of the clinic.Injectable treatmentsCommon topics about the logistics of treatment deliveryincluded lengthy pre- and post-assessment times, shortoperating hours and lack of flexibility to accommodatework schedules, and the overall amount of time spent atthe clinic. Males discussed the schedule, work, transportation,and rules of the clinic.And uh, I found it to uh, going three times a day wasalmost, a full-time job…Cause I mean, three times, each,each session you know? With travel time there and backit, it took you know, like, you know, between five and sixhours a, a, day, right? And it’s basically impossible to uh,try and go back to work. [male non-Aboriginalparticipant, age 50, DAM, responder, retained]Some participants, mostly female, discussed the adjust-ment that was required for injecting in a supervised set-ting, including changes to the routine (i.e., preparationof own drug) and injection site (i.e., jugular, leg). An-other complaint that a few participants discussed wasthe time restriction set for the injection room (approxi-mately 7 min). The reason for their difficulty with self-administering the injectable medications was because ofpoor vein health resulting from many years of injectiondrug use.It was hard for me because I’m not used to being aroundpeople when I did mine, right. And it made me nervousso I always had a hard time. [female Aboriginalparticipant, age 50, HDM, responder, retained]Participant: Well, difficult, cause, um, being uh,shooting dope for so long, and I don’t have any veinsleft, so, the timeframe, and, uh, to hit being so largeuh, and in turkey baster syringe. and having a hardtime getting a vein, let alone in 7 minutes. And, Iended up trying to, to do it intramuscularly, uh a lotof times. [inaudible]wasn’t, it wasn’t enough. By the time I came to, it’squite a few hours before it came time to get my dosefor the next day. I was starting to, go through withdrawals.And I was on methadone for like 2 months on thatdose and I was using all the time. And the doctorwouldn’t put me up any more. [male, non-Aboriginalparticipant, age 40, MMT, responder, retained]Interviewer: Uh huh [affirmative] and did that changeyour high then?Oviedo-Joekes et al. Addiction Science & Clinical Practice 2014, 9:21 Page 7 of 10http://www.ascpjournal.org/content/9/1/21Participant: No. it’s uh, there was enough of it, in uh,you know, just, just takes a couple minutes and, tokick in. [male non-Aboriginal participant, age 50,DAM, responder, retained]Participants also described the dose and quality of themedications they were receiving in NAOMI as being sig-nificantly better compared to street heroin. The im-proved drug quality allowed them to worry less aboutwhat other unknown substances they were inadvertentlytaking.Now, my first shot in NAOMI was 15 milligrams. Theeffect I got off of that was damned close to the effect I gotoff of shooting a quarter gram [of street heroin]…that’svery drastic. And uh, it’s an eye opener, man…thatprobably alone would have given me, reason enough to,consider treatment of some kind. [male non-Aboriginalparticipant, age 40, DAM, responder, retained]Recommendations for improving the delivery ofinjectable treatmentLogistics of the treatment were the most commonly refer-enced recommendation for improving NAOMI. Partici-pants suggested changes to the structure of the program,including longer operating hours, more flexibility in ses-sion times, and less time required for each visit. A fewmale participants discussed the interference of the strictschedule on their ability to work. Additional programswere also a common recommendation, including voca-tional and life skills support, as well as treatment for otherdrug use. Although the treatment brought stability to par-ticipants’ lives, there were concerns about how best to usethe time freed by the treatment.If this was to ever get off the ground and be apermanent thing, that something be implemented…totake up this free time…maybe train for this or go toschool part-time or something just so you don’t haveall that time on your hands. [male Aboriginalparticipant, age 51, DAM, responder, retained]Participants also suggested that the treatments shouldhave been provided for a longer period of time, or tran-sitioned into a program, in order to enhance and sustainthe benefits of the treatments.Because by the time it was over that was when I reallyfelt that I was starting to stabilize, you know… on mylifestyle… But if I’d had more time, maybe I wouldhave been able to…go another couple of routes, like,uh, think about school or maybe even a job. But…itwas over a little too quick for that. [male Aboriginalparticipant, age 40, DAM, responder, retained]Ending NAOMIParticipants receiving injectable treatment primarilydiscussed the process and emotions of ending NAOMI.Many study participants reported that they were ableto transition or continue on MMT with their NAOMIstudy physician, either at the site of NAOMI or incommunity-based clinics. A few refused MMT becauseit did not work for them or because of unsuccessfultransitions (e.g., disagreements with health care provider).Some participants receiving injectable treatments discussedhow NAOMI enabled them to consider engaging inother treatment options (i.e., detox, MMT) that previouslywould not have been considered.Well, you know one of the effects of NAOMI andI’m not sure how or why, I am more accepting ofmethadone now than I was before. More able to,uh you know, to accept, the reality of it. You know,uh [pause] I’m not using as much opiates as I didbefore, uh, at NAOMI, you know? And I, I don’t,run to find opiates as quickly as I used to. [malenon-Aboriginal participant, age 51, DAM,responder, retained]Participants indicated that even though they under-stood that injectable treatments were not guaranteed be-yond the end of the study, they experienced anxiety, fear,sadness, and stress due to ending the study.And I was never under any illusions. And youknow, again, on the street people would say, yeah,but what are you gonna do when it’s over? What Iwould do the same as I did before. When it’s over.You know, it’s a respite. It’s a gift. And I’m notgonna sit here and complain about it. [male non-Aboriginal participant, age 51, DAM, responder,retained]Participants remained hopeful that the evidence fromNAOMI would expand treatment options in Canada, andthey were happy to have been part of the study. None ofthe interviewed participants expressed regret at being partof NAOMI.I was happy to be part of it…it gave me a bit of hopeinto the future of um, addictions treatment in […]Canada. Um, [pause]…there was an adjustmentperiod, when I got out of NAOMI there. I was sad.And I was depressed for a little while, because youknow, when you have something like that comes to anend, not only did I really miss the comfort and theattention and the really caring staff, which I do stillmiss. [male non-Aboriginal participant, age 40, DAM,responder, retained]Oviedo-Joekes et al. Addiction Science & Clinical Practice 2014, 9:21 Page 8 of 10http://www.ascpjournal.org/content/9/1/21DiscussionThe aim of this study was to explore how participants inthe Canadian clinical trial testing injectable opioids per-ceived the treatment received. The participants’ perspec-tives of treatment with medically prescribed DAM wereconcordant with the rationale of this model of care: byproviding pharmaceutical-grade heroin in a supervisedhealth care setting that also provided comprehensivehealth services, we engaged street heroin-injecting indi-viduals to treatment and offered them an opportunity toreduce harms and illegal activities and improve theirhealth.A prior study showed that participants in NAOMI ap-plied to the clinical trial mainly to receive “free heroin”[33]. In this study, the participants signified the possibil-ity of receiving free heroin as an opportunity for gettingtheir lives back. The provision of medically prescribedinjectable opioids is described as introducing stability intheir lives. Now that the substance they were dependenton was taken care of, there was no need to be involvedin illicit activities or sex work and they could direct theirresources to finding housing and possibly employment.Also, through the daily contact with health care workers,they were diagnosed and treated for other comorbidities.This study provides an explanation as to why this treat-ment is so effective, despite the strict regimen of the su-pervised delivery model [14]. While participants discussedthe challenges associated with the logistics of treatmentdelivery (e.g., schedules, no take-homes, injecting amongstrangers), it does not reflect the emotions and intensity inthe way they described their lives while they were un-treated: waking up in a panic, stealing, feeling hopeless,depressed, and like a “total wreck.” The discourses re-corded in this study suggest that participants found thesupervised delivery model stringent, but they highly val-ued the stability it brought to their lives. This stability isdescribed mostly in relation to the provision of the inject-able medications they considered beneficial, but also inthe supportive model of care. These results are consistentwith the findings of the Dutch and Andalusian reports onparticipants’ perceptions of this treatment [20,21]. For ex-ample, in the Dutch study, participants complained abouthow the tight clinic schedules interfered with their dailyactivities, such as household activities or work. However,this schedule also provided structure to their lives, mostlyamong those engaged in street activities, such as sex workor drug dealing [21].This study shows that the treatment provided wasconsidered effective at stopping the use of illicit opioids,confirming our prior results [12]. As expected, partici-pants receiving injectable opioids at the clinic reportednot using street opioids. As in prior studies [19-21], ourdata show that the secure drug supply translated into asignificant decrease of engagement in illicit activities andthe daily street hustle. This release of time, and in somecases resources, introduces an important challenge forpatients and the community: how to fill this free time.For example, participants in the Andalusian study con-veyed the challenge of suddenly not having to spend theday going after heroin and how their needs beyond her-oin became evident, such as lack of skills to obtain em-ployment [22]. Results from the parent trial found nochanges in the use of cocaine from baseline [12], and ac-cordingly, in this study most of the participants reportedhaving reduced or not changed their cocaine use. How-ever, those few whose cocaine use increased attributed itto having more funds available and their struggle to dis-engage from the drug scene.In NAOMI’s analysis of satisfaction with treatment,after controlling for treatment effectiveness, those ran-domized to the injection group were significantly moresatisfied with treatment than those in the MMT group[18]. From the open-ended comments section of theClient Satisfaction Questionnaire, participants in botharms of the study described the need for additional an-cillary and nutritional services. The present findingsconfirm this, with participants expressing that voca-tional and skills training would be beneficial programsas participants begin to experience stability in theirlives and are confronted with the need to plan for theirfuture.The gender-based analysis in the NAOMI study foundthat retention and clinical response to DAM treatmentwere slightly lower among women than men (thoughnot statistically significant) [34]. In the qualitative analysis,men and women had similar discourses, except womendiscussed the adjustment required for the environmentand physical site of injectable treatment administration(e.g., the public environment of the injection room),whereas males focused on the challenging schedule ofthe treatment and its impact on their ability to work.Women’s experiences with the logistics of the clinicalcare setting may explain the slightly reduced retentionand response rates.Some participants (mainly male) were concernedabout the schedule of the treatment and its impact ontheir ability to work. The potential impact on the cap-acity for employment of coming to a clinic two to threetimes per day has been raised as an issue of this treat-ment model [35]. However, there are many alternativesunder this model that would facilitate patients adjust-ing to a work schedule. For example, clinics in Europeoffer a combination of injectable and oral long-actingopioids (e.g., methadone), and have diversified options(e.g., methadone, morphine, DAM, etc.) for managingindividual patient needs [36]. Also, several studies showthat after a period of stabilization some patients voluntar-ily transition to oral methadone or abstinence-orientedDrug Alcohol Rev 2013, 32:566–573.Oviedo-Joekes et al. Addiction Science & Clinical Practice 2014, 9:21 Page 9 of 10http://www.ascpjournal.org/content/9/1/21treatment [37,38], options that allow a schedule moreamenable to work.Due to clinic capacity, participants entered the trial ona staggered schedule to complete the planned samplesize over time. The last participants finished the treat-ment in April and June 2008, respectively, in Vancouverand Montreal. This study collected data between Februaryand September 2008. Participants expressed their absolutedisappointment with the end of the injectable treatmentsand explained the negative impact on their lives. Regard-less, they saw the NAOMI experience as a positive one.They referenced mostly two aspects: First, for a period oftime, they obtained stability and had the chance to makeplans beyond how to obtain the drug. Second, they hadthe hope that NAOMI would become a program and wereproud of having helped to build evidence for this case.This study provides further explanation of why treat-ment with injectable DAM, despite the supervised modelof care, can be effective. Our evidence adds to the current(and limited) data on participant perceptions of treatmentwith injectable DAM for long-term opioid dependence.Such data are particularly useful as future programswith this treatment are developed. Patient engagementin chronic disease treatment is essential to promotingtreatment access and retention, thus reducing the bur-den of disease for the individual and society.Competing interestsThe authors declare that they have no competing interests.Authors’ contributionsEOJ and KM made substantial contributions to analysis and interpretation;EOJ also led preparation of the manuscript. KL and JC made substantialcontributions to the acquisition of NAOMI data and assisted with draftingthe manuscript; DCM, SB, AA, and MTS made substantial contributions toNAOMI’s conception and design and interpretation of the present data. Allauthors read and approved the final manuscript and agree to beaccountable to the integrity of the work.AcknowledgementsThe NAOMI trial was funded through an operating grant from the CanadianInstitutes of Health Research with additional support from the CanadaFoundation for Innovation, the Canada Research Chairs Program, theUniversity of British Columbia, Providence Health Care, the University ofMontreal, Centre de Recherche et Aide aux Narcomanes, the Government ofQuebec, Vancouver Coastal Health Authority, and the BC Centre for DiseaseControl. Dr. Oviedo-Joekes is also funded by the Michael Smith Foundationfor Health Research and the Canadian Institutes of Health Research. Theauthors wish to acknowledge the dedication of N. Laliberté, C. Gartry, K. Sayers.Guevremont, P. Schneeberger, J. Chettiar, J. Lawlor, P. Pelletier, S. Maynard,M.-I. Turgeon, G. Brunelle, A. Chan, S. MacDonald, T. Corneil, J. Geller, S.Jutha, S. Chai, M. Piaseczny, S. Sizto, and the many remaining staff andmembers of the Data Safety Monitoring Board (A. Marlatt, N. El-Guebaly, J.Raboud, D. Roy). Most importantly, the authors wish to acknowledge andthank the NAOMI trial participants.Author details1Centre for Health Evaluation & Outcome Sciences, Providence Health Care,St. Paul’s Hospital, 575- 1081 Burrard St., Vancouver, BC V6Z 1Y6, Canada.2School of Population and Public Health, University of British Columbia, 22063East Mall, Vancouver, BC V6T 1Z3, Canada. Centre Hospitalier de l’Universitéde Montréal, Hôpital Saint-Luc, CHUM Montréal, QC, Montréal H2X 3J4,Canada. 4Centre for Addiction Research BC, University of Victoria, 230020. Romo N, Poo M, Ballesta R, PEPSA Team: From illegal poison to legalmedicine: a qualitative research in a heroin-prescription trial in Spain.Drug Alcohol Rev 2009, 28:186–195.21. 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