Dataset Information

Treatment of opioid dependence with depot buprenorphine (CAM2038) in custodial settings.

ABSTRACT:

Background and aims

Opioid agonist treatment is effective but resource intensive to administer safely in custodial settings, leading to significant under-treatment of opioid dependence in these settings world-wide. This study assessed the safety of subcutaneous slow-release depot buprenorphine in custody.

Design

Open-label, non-randomized trial.

Setting

Correctional centres in New South Wales, Australia.

Participants

Sixty-seven men and women, aged ≥ 18 years of various security classifications with a diagnosis of moderate to severe DSM-5 opioid use disorder currently serving a custodial sentence of ≥ 6 months were recruited between November 2018 and July 2019. Patients not in opioid agonist treatment at recruitment commenced depot buprenorphine; patients already stable on oral methadone treatment were recruited to the comparison arm.

Intervention and comparator

Depot buprenorphine (CAM2038 weekly for 4 weeks then monthly) and daily oral methadone.

Measurements

Safety was assessed by adverse event (AE) monitoring and physical examinations at every visit. Participants were administered a survey assessing self-reported diversion and substance use at baseline and weeks 4 and 16.

Findings

Retention in depot buprenorphine treatment was 92.3%. Ninety-four per cent of patients reported at least one adverse event, typically mild and transient. No diversion was identified. The prevalence of self-reported non-prescribed opioid use among depot buprenorphine patients decreased significantly between baseline (97%) and week 16 (12%, odds ratio = 0.0035, 95% confidence interval = 0.0007-0.018, P < 0.0001).

Conclusions

This first study of depot buprenorphine in custodial settings showed treatment retention and outcomes comparable to those observed in community settings and for other opioid agonist treatment used in custodial settings, without increased risk of diversion.

SUBMITTER: Dunlop AJ

PROVIDER: S-EPMC9291502 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Treatment of opioid dependence with depot buprenorphine (CAM2038) in custodial settings.

Dunlop Adrian J AJ White Bethany B Roberts Jillian J Cretikos Michelle M Attalla Dena D Ling Rod R Searles Andrew A Mackson Judith J Doyle Michael F MF McEntyre Elizabeth E Attia John J Oldmeadow Christopher C Howard Mark V MV Murrell Terry T Haber Paul Steven PS Lintzeris Nicholas N

Addiction (Abingdon, England) 20210716 2

<h4>Background and aims</h4>Opioid agonist treatment is effective but resource intensive to administer safely in custodial settings, leading to significant under-treatment of opioid dependence in these settings world-wide. This study assessed the safety of subcutaneous slow-release depot buprenorphine in custody.<h4>Design</h4>Open-label, non-randomized trial.<h4>Setting</h4>Correctional centres in New South Wales, Australia.<h4>Participants</h4>Sixty-seven men and women, aged ≥ 18 years of vari ...[more]

PMID: 34184798

Similar Datasets

Project description:AimsTo assess the long-term safety of subcutaneous buprenorphine (CAM2038) weekly and monthly depots.DesignPhase 3, open-label, observational, multi-centre 48-week trial (ClinicalTrials.gov NCT02672111).SettingTwenty-six out-patient sites (United States, United Kingdom, Hungary, Denmark, Sweden, Germany, Australia) between 14 December 2015 and 12 April 2017.ParticipantsTwo hundred and twenty-eight adults with opioid use disorder; 227 received CAM2038 (37 initiated onto CAM2038 and 190 converted from sublingual buprenorphine).InterventionsCAM2038 weekly (8, 16, 24 or 32 mg) or monthly (64, 96, 128 or 160 mg) with flexible dosing and individualized titration utilizing multiple CAM2038 weekly and monthly doses.MeasurementsSafety variables, urine toxicology samples and self-reported illicit opioid use were collected at each visit. Participants were administered a patient satisfaction survey at months 6 and 12, completed by 162 of 227 (71.4%) participants.FindingsThe study treatment period was completed by 167 of 227 (73.6%) participants. At least one treatment-emergent adverse event (TEAE) was reported by 143 of 227 (63.0%) participants, of whom 60 of 227 (26.4%) reported as being drug-related. Most of the TEAEs, reported by 128 of 227 (56.4%) of participants, were mild or moderate in intensity. Injection-site reactions were reported by 46 of 227 (20.3%) participants, with most [45 of 46 (97.8%)] reported as mild to moderate. Five participants (2.2%) discontinued the study drug due to a TEAE, two cases (0.9%) of which were injection-site-related. No serious adverse events were attributed to the study drug. Among those remaining in the study, the percentage of opioid-negative urine tests combined with self-reports was 63.0% (17 of 27) in new-to-treatment participants and 82.8% (111 of 134) for those converted from sublingual buprenorphine. Participants reported high levels of satisfaction with CAM2038.ConclusionsSubcutaneous buprenorphine delivered weekly or monthly (CAM2038) was well tolerated, with a systemic safety profile consistent with the known profile of sublingual buprenorphine. CAM2038 weekly and monthly was associated with high retention rates and low levels of illicit opioid use throughout this study.

Project description:ImportanceBuprenorphine is an efficacious, widely used treatment for opioid use disorder (OUD). Daily oral transmucosal formulations can be associated with misuse, diversion, and nonadherence; these limitations may be obviated by a sustained release formulation.ObjectiveTo evaluate the ability of a novel, weekly, subcutaneous buprenorphine depot formulation, CAM2038, to block euphorigenic opioid effects and suppress opioid withdrawal in non-treatment-seeking individuals with OUD.Design, setting, and participantsThis multisite, double-blind, randomized within-patient study was conducted at 3 controlled inpatient research facilities. It involved 47 adults with DSM-V moderate-to-severe OUD. The study was conducted from October 12, 2015 (first patient enrolled), to April 21, 2016 (last patient visit).InterventionsA total of five 3-day test sessions evaluated the response to hydromorphone (0, 6, and 18 mg intramuscular in random order; 1 dose/session/day). After the first 3-day session (ie, qualification phase), participants were randomized to either CAM2038 weekly at 24 mg (n = 22) or 32 mg (n = 25); the assigned CAM2038 dose was given twice, 1 week apart (day 0 and 7). Four sets of sessions were conducted after randomization (days 1-3, 4-6, 8-10, and 11-13).Main outcomes and measuresThe primary end point was maximum rating on the visual analog scale for drug liking. Secondary end points included other visual analog scale (eg, high and desire to use), opioid withdrawal scales, and physiological and pharmacokinetic outcomes.ResultsA total of 46 of 47 randomized participants (mean [SD] age, 35.5 [9] years; 76% male [n = 35]) completed the study. Both weekly CAM2038 doses produced immediate and sustained blockade of hydromorphone effects (liking maximum effect, CAM2038, 24 mg: effect size, 0.813; P < .001, and CAM2038, 32 mg: effect size, 0.753; P < .001) and suppression of withdrawal (Clinical Opiate Withdrawal Scale, CAM2038, 24 mg: effect size, 0.617; P < .001, and CAM2038, 32 mg: effect size, 0.751; P < .001). CAM2038 produces a rapid initial rise of buprenorphine in plasma with maximum concentration around 24 hours, with an apparent half-life of 4 to 5 days and approximately 50% accumulation of trough concentration from first to second dose (trough concentration = 0.822 and 1.23 ng/mL for weeks 1 and 2, respectively, with 24 mg; trough concentration = 0.993 and 1.47 ng/mL for weeks 1 and 2, respectively, with 32 mg).Conclusions and relevanceCAM2038 weekly, 24 and 32 mg, was safely tolerated and produced immediate and sustained opioid blockade and withdrawal suppression. The results support the use of this depot formulation for treatment initiation and stabilization of patients with OUD, with the further benefit of obviating the risk for misuse and diversion of daily buprenorphine while retaining its therapeutic benefits.Trial registrationClinicaltrials.gov Identifier: NCT02611752.

Project description:Background:Among people living in detention, substance use is highly prevalent, including opioid dependence. Opioid agonist treatment (OAT) has been established as an evidence-based, first-line treatment for opioid dependence. Despite high prevalence of opioid dependence, conclusive data regarding its prevalence and the OAT practice in German prisons is scarce; rather, the existing data widely diverges concerning the rates of people in detention receiving OAT. Materials and Methods:We conducted a cross-sectional survey of all detention facilities in Berlin. On the date of data collection, a full census of the routine records was completed based on the medical documentation system. For each opioid dependent individual, we extracted sociodemographic data (i.e., age, sex, and non-/German nationality, whether people experienced language-related communication barriers), information about OAT, comorbidities (HIV, hepatitis C, schizophrenia), and the detention center, as well as the anticipated imprisonment duration and sentence type. The data was first analyzed descriptively and secondly in an evaluative-analytical manner by analyzing factors that influence the access to OAT of people living in detention. Results:Among the 4,038 people in detention in the Berlin custodial setting under investigation, we identified a 16% prevalence of opioid dependence. Of the opioid-dependent individuals, 42% received OAT; 31% were treated with methadone, 55% were treated with levomethadone, and 14% were treated with buprenorphine. Access to OAT seemed mainly dependent upon initial receipt of OAT at the time of imprisonment, detention duration, the prisons in which individuals were detained, German nationality, and sex. The overall prevalence of HIV was 4-8%, hepatitis C was 31-42%, and schizophrenia was 5%. Conclusions:The prevalence of opioid dependence and access to OAT remains a major health issue in the custodial setting. OAT implementation must be especially intensified among male, non-German, opioid-dependent individuals with a short detention period. Treatment itself must be diversified regarding the substances used for OAT, and institutional treatment differences suggest the need for a consistent treatment approach and the standardized implementation of treatment guidelines within local prison's standard operating procedures. Testing for infectious diseases should be intensified among opioid-dependent people living in detention to address scarcely known infection statuses and high infection rates.

Project description:BackgroundRecently developed buprenorphine depot injections have the potential to reduce risk for diversion and misuse, and to increase adherence with fewer visits for supervised intake. However, it is unclear how patients perceive this new form of medication. The purpose of this study was to explore patients' experiences of depot injections and their reasons for continuing, discontinuing, or declining depot injection treatment.MethodsWe conducted semi-structured qualitative interviews with 32 people, 14 of whom had ongoing depot injection treatment, 11 who had discontinued depot-injections and switched to other medication and seven who had declined treatment with depot formulations. Interviews were transcribed, coded, and analysed using NVivo, based on this overall stratification into three participant groups.ResultsThe main categories relate to the effects and side effects of the depot formulation, social and practical factors, psychological benefits and disadvantages, and interactions with treatment staff. Social and practical factors were of importance for choosing depot formulations, such as increased freedom and their making it easier to combine treatment with work and family life, as well as psychological advantages including "feeling normal". Initial withdrawal symptoms that resolved themselves after a number of injections were reported by most participants. Reliable information and patient-staff relationships characterized by trust helped patients to cope with these initial problems. Those who discontinued treatment often did so near the beginning of the treatment, reporting withdrawal symptoms and insufficient effects as the main reasons. Coercion and insufficient information contributed to a negative pharmaceutical atmosphere at one of the clinics, which may have adversely influenced perceptions of depot formulations and decreased willingness to accept and continue treatment.ConclusionsBuprenorphine depot injections may have social, practical, and psychological benefits compared to other formulations. However, depot injections are not perceived as an attractive option by all patients. Trust, consistent and adequate information, and awareness of the implications of the pharmaceutical atmosphere should be considered when introducing new medications.

Project description:ImportancePatient-reported outcomes in the treatment of opioid dependence may differ between subcutaneously administered depot buprenorphine and daily sublingual buprenorphine.ObjectiveTo compare patient satisfaction between depot buprenorphine and sublingual buprenorphine in adult outpatients with opioid dependence.Design, setting, and participantsThis open-label, randomized clinical trial was conducted among adult patients with opioid dependence at 6 outpatient clinical sites in Australia from October 2018 to September 2019. Data analysis was conducted from October 2019 to May 2020.InterventionsParticipants were randomized to receive treatment with weekly or monthly depot buprenorphine or daily sublingual buprenorphine over 24 weeks.Main outcomes and measuresThe primary end point was the difference in global treatment satisfaction, assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 (range, 0-100; higher score indicates greater satisfaction) at week 24. Secondary end points included other patient-reported outcomes, including quality of life, treatment burden, and health-related outcomes, as well as measures of opioid use, retention in treatment, and safety.ResultsA total of 119 participants (70 [58.8%] men; mean [SD] age, 44.4 [10.5] years) were enrolled, randomized to, and received either depot buprenorphine (60 participants [50.4%]) or sublingual buprenorphine (59 participants [49.6%]). From the initial sample of 120, a participant (0.8%) in the sublingual buprenorphine group withdrew consent and did not receive study treatment. All participants were receiving sublingual buprenorphine when enrolled. The mean TSQM global satisfaction score was significantly higher for the depot group compared with the sublingual group at week 24 (mean [SE] score, 82.5 [2.3] vs 74.3 [2.3]; difference, 8.2; 95% CI, 1.7 to 14.6; P = .01). Improved outcomes were also observed for several secondary end points after treatment with depot buprenorphine (eg, mean [SE] treatment burden assessed by the Treatment Burden Questionnaire global score, on which lower scores indicate lower burden: 13.2 [2.6] vs 28.6 [2.5]; difference, -15.4; 95% CI, -22.6 to -8.2; P < .001). Thirty-nine participants (65.0%) in the depot buprenorphine group experienced 117 adverse drug reactions, mainly injection site reactions of mild intensity following subcutaneous administration, and 12 participants (20.3%) in the sublingual buprenorphine group experienced 21 adverse drug reactions. No participants withdrew from the trial medication or the trial due to adverse events.Conclusions and relevanceIn this study, participants receiving depot buprenorphine reported improved treatment satisfaction compared with those receiving sublingual buprenorphine. The results highlight the application of patient-reported outcomes as alternative end points to traditional markers of substance use in addiction treatment outcome studies.Trial registrationanzctr.org.au Identifier: ANZCTR12618001759280.

Project description:ImportanceOpioid-dependent patients often use the emergency department (ED) for medical care.ObjectiveTo test the efficacy of 3 interventions for opioid dependence: (1) screening and referral to treatment (referral); (2) screening, brief intervention, and facilitated referral to community-based treatment services (brief intervention); and (3) screening, brief intervention, ED-initiated treatment with buprenorphine/naloxone, and referral to primary care for 10-week follow-up (buprenorphine).Design, setting, and participantsA randomized clinical trial involving 329 opioid-dependent patients who were treated at an urban teaching hospital ED from April 7, 2009, through June 25, 2013.InterventionsAfter screening, 104 patients were randomized to the referral group, 111 to the brief intervention group, and 114 to the buprenorphine treatment group.Main outcomes and measuresEnrollment in and receiving addiction treatment 30 days after randomization was the primary outcome. Self-reported days of illicit opioid use, urine testing for illicit opioids, human immunodeficiency virus (HIV) risk, and use of addiction treatment services were the secondary outcomes.ResultsSeventy-eight percent of patients in the buprenorphine group (89 of 114 [95% CI, 70%-85%]) vs 37% in the referral group (38 of 102 [95% CI, 28%-47%]) and 45% in the brief intervention group (50 of 111 [95% CI, 36%-54%]) were engaged in addiction treatment on the 30th day after randomization (P < .001). The buprenorphine group reduced the number of days of illicit opioid use per week from 5.4 days (95% CI, 5.1-5.7) to 0.9 days (95% CI, 0.5-1.3) vs a reduction from 5.4 days (95% CI, 5.1-5.7) to 2.3 days (95% CI, 1.7-3.0) in the referral group and from 5.6 days (95% CI, 5.3-5.9) to 2.4 days (95% CI, 1.8-3.0) in the brief intervention group (P < .001 for both time and intervention effects; P = .02 for the interaction effect). The rates of urine samples that tested negative for opioids did not differ statistically across groups, with 53.8% (95% CI, 42%-65%) in the referral group, 42.9% (95% CI, 31%-55%) in the brief intervention group, and 57.6% (95% CI, 47%-68%) in the buprenorphine group (P = .17). There were no statistically significant differences in HIV risk across groups (P = .66). Eleven percent of patients in the buprenorphine group (95% CI, 6%-19%) used inpatient addiction treatment services, whereas 37% in the referral group (95% CI, 27%-48%) and 35% in the brief intervention group (95% CI, 25%-37%) used inpatient addiction treatment services (P < .001).Conclusions and relevanceAmong opioid-dependent patients, ED-initiated buprenorphine treatment vs brief intervention and referral significantly increased engagement in addiction treatment, reduced self-reported illicit opioid use, and decreased use of inpatient addiction treatment services but did not significantly decrease the rates of urine samples that tested positive for opioids or of HIV risk. These findings require replication in other centers before widespread adoption.Trial registrationclinicaltrials.gov Identifier: NCT00913770.

Dataset Information

Treatment of opioid dependence with depot buprenorphine (CAM2038) in custodial settings.

Background and aims

Design

Setting

Participants

Intervention and comparator

Measurements

Findings

Conclusions

Publications

Treatment of opioid dependence with depot buprenorphine (CAM2038) in custodial settings.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets