Dataset Information

Comparing opium tincture and methadone for medication-assisted treatment of patients with opioid use disorder: Protocol for a multicenter parallel group noninferiority double-blind randomized controlled trial.

ABSTRACT: OBJECTIVES:This is the first study to compare the safety and efficacy of opium tincture (OT) with methadone for treatment of opioid use disorder. METHODS:In this multicenter, double-blind, noninferiority controlled trial, a stratified sample of 204 participants with opioid use disorder were recruited from community outreach, drop-in centers, and triangular clinics. Participants were excluded in case of active participation in another treatment program for opioid use disorder, hypersensitivity to trial medications, pregnancy, and certain serious medical conditions. They were randomized to receive either OT or methadone with an allocation ratio of 1:1 using a patient-centered flexible dosing strategy. Eligible participants were followed for a period of 12 weeks. Primary outcome is the difference in percentage of patients retained in the treatment. Secondary outcomes are craving, withdrawal symptoms, physical health, mental health, quality of life, and severity of substance use problems, cognitive function, safety profile, cost-effectiveness, and participants' satisfaction. Both intention-to-treat and per-protocol analyses will be conducted. The Ethics Board of the University of British Columbia and Tehran University of Medical Sciences approved the study. (clinicaltrials.gov; NCT02502175). RESULTS:To be reported after final analysis. CONCLUSIONS:If shown to be effective, OT will diversify the options for medication-assisted treatment of opioid use disorder.

SUBMITTER: Nikoo M

PROVIDER: S-EPMC6877259 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Comparing opium tincture and methadone for medication-assisted treatment of patients with opioid use disorder: Protocol for a multicenter parallel group noninferiority double-blind randomized controlled trial.

Nikoo Mohammadali M Moazen-Zadeh Ehsan E Nikoo Nooshin N Javidanbardan Sanam S Kazemi Alireza A Choi Fiona F Vogel Marc M Gholami Ali A Tavakoli Saeed S Givaki Reza R Jazani Majid M Mohammadian Fatemeh F Markazi Moghaddam Nader N Goudarzi Nasser N Schutz Christian C Jang Kerry K Akhondzadeh Shahin S Krausz Michael M

International journal of methods in psychiatric research 20190204 1

<h4>Objectives</h4>This is the first study to compare the safety and efficacy of opium tincture (OT) with methadone for treatment of opioid use disorder.<h4>Methods</h4>In this multicenter, double-blind, noninferiority controlled trial, a stratified sample of 204 participants with opioid use disorder were recruited from community outreach, drop-in centers, and triangular clinics. Participants were excluded in case of active participation in another treatment program for opioid use disorder, hype ...[more]

PMID: 30714249

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Project description:Opioid use disorder (OUD) represents a public health crisis in the United States. Medication for opioid use disorder (MOUD) with buprenorphine in primary care is a proven OUD treatment strategy. MOUD induction is when patients begin withdrawal and receive the first doses of buprenorphine. Differences between induction methods might influence short-term stabilization, long-term maintenance, and quality of life. This paper describes the protocol for a study designed to: (1) compare short-term stabilization and long-term maintenance treatment engagement in MOUD in patients receiving office, home, or telehealth induction and (2) identify clinically-relevant practice and patient characteristics associated with successful long-term treatment. The study design is a randomized, parallel group, pragmatic comparative effectiveness trial of three care models of MOUD induction in 100 primary care practices in the United States. Eligible patients are at least 16 years old, have been identified by their clinician as having opioid dependence and would benefit from MOUD. Patients will be randomized to one of three induction comparators: office, home, or telehealth induction. Primary outcomes are buprenorphine medication-taking and illicit opioid use at 30, 90, and 270 days post-induction. Secondary outcomes include quality of life and potential mediators of treatment maintenance (intentions, planning, automaticity). Potential moderators include social determinants of health, substance use history and appeal, and executive function. An intent to treat analysis will assess effects of the interventions on long-term treatment, using general/generalized linear mixed models, adjusted for covariates, for the outcomes analysis. Analysis includes practice- and patient-level random effects for hierarchical/longitudinal data. No large-scale, randomized comparative effectiveness research has compared home induction to office or telehealth MOUD induction on long-term outcomes for patients with OUD seen in primary care settings. The results of this study will offer primary care providers evidence and guidance in selecting the most beneficial induction method(s) for specific patients.

Project description:Substitution with opioid-agonists (e.g., methadone) has shown to be an effective treatment for chronic long-term opioid dependency. Patient satisfaction with treatment has been associated with improved addiction treatment outcomes. However, there is a paucity of studies evaluating patients' satisfaction with Opioid Substitution Treatment (OST). In the present study, participants' satisfaction with OST was evaluated at 3 and 12 months. We sought to test the relationship between satisfaction and patients' characteristics, the treatment modality received and treatment outcomes.Data from a randomized controlled trial, the North American Opiate Medication Initiative (NAOMI), conducted in Vancouver and Montreal (Canada) between 2005-2008, was analyzed. The NAOMI study compared the effectiveness of oral methadone vs. injectable diacetylmorphine over 12 months. A small sub-group of patients received injectable hydromorphone on a double blind basis with diacetylmorphine. The Client Satisfaction Questionnaire (CSQ-8) was used to measure satisfaction with treatment. CSQ-8 scores, as well as retention and response to treatment, did not differ between those receiving hydromorphone and diacetylmorphine at 3 or 12 months assessments; therefore, these two groups were analyzed together as the 'injectable' treatment group.A total of 232 (92%) and 237 (94%) participants completed the CSQ-8 at 3 and 12 months, respectively. Participants in both groups were highly satisfied with treatment. Independent of treatment group, participants satisfied with treatment at 3 months were more likely to be retained at 12 months. Multivariate analysis indicated that satisfaction was greater among those randomized to the injection group after controlling for treatment effectiveness. Participants who were retained, responded to treatment, and had fewer psychological symptoms were more satisfied with treatment. Finally, open-ended comments were made by 149 (60.3%) participants; concerns about the randomization process and the study ending were most commonly reported by participants receiving the oral and injectable medications, respectively.The higher satisfaction among those receiving medically prescribed injectable diacetylmorphine (or hydromorphone) supports current evidence regarding the attractiveness of this treatment for long-term, opioid-dependent individuals not benefiting sufficiently from other treatments. In addition, the measurement of treatment satisfaction provides valuable information about participants at risk of relapse and in need of additional services.ClinicalTrials.gov Identifier: NCT00175357.

Project description:Abstract Background The overlap between justice system involvement and drug use is well‐documented. Justice‐involved people who misuse opioids are at high risk for relapse and criminal recidivism. Criminal justice policymakers consider opioid‐specific medication‐assisted therapies (MATs) one approach for improving outcomes for this population. More research is needed that explores the impacts of opioid‐specific MATs for justice‐involved people. Objectives This study sought to assess the effects of opioid‐specific MAT for reducing the frequency and likelihood of criminal justice and overdose outcomes for current or formerly justice‐involved individuals. Search Methods Records were searched between May 7, 2021 and June 23, 2021. We searched a total of sixteen proprietary and open access databases that included access to gray literature and conference proceedings. The bibliographies of included studies and relevant reviews were also searched. Selection Criteria Studies were eligible for inclusion in the review if they: (a) assessed the effects of opioid‐specific MATs on individual‐level criminal justice or overdose outcomes; included (b) a current or formerly justice‐involved sample; and (c) a randomized or strong quasi‐experimental design; and c) were published in English between January 1, 1960 and October 31, 2020. Data Collection and Analysis We used the standard methodological procedures as expected by The Campbell Collaboration. Main Results Twenty studies were included, representing 30,119 participants. The overall risk of bias for the experimental studies ranged from “some” to “high” and for quasi‐experimental studies ranged from “moderate” to “serious.” As such, findings must be interpreted against the backdrop of less‐than‐ideal methodological contexts. Of the 20 included studies, 16 included outcomes that were meta‐analyzed using mean log odds ratios (which were reported as mean odds ratios). Mean effects were nonsignificant for reincarceration (odds ratio [OR] = 0.93 [0.68, 1.26], SE = .16), rearrest (OR = 1.47 [0.70, 3.07], SE = 0.38), and fatal overdose (OR = 0.82 [0.56, 1.21], SE = 0.20). For nonfatal overdose, the average effect was significant (OR = 0.41 [0.18, 0.91], SE = 0.41, p < 0.05), suggesting that those receiving MAT had nearly 60% reduced odds of a nonfatal overdose. Implications for Policy, Practice, and Research The current review supports some utility for adopting MAT for the treatment of justice‐involved people with opioid addiction, however, more studies that employ rigorous methodologies are needed. Researchers should work with agencies to improve adherence to medication regimens, study design, and collect more detailed information on participants, their criminal and substance use histories, onset, and severity. This would help clarify whether treatment and control groups are indeed comparable and provide better insight into the potential reasons for participant dropout, treatment failure, and the occurrence of recidivism or overdose. Outcomes should be assessed in multiple ways, if possible (e.g., self‐report and official record), as reliance on official data alone may undercount participants' degree of criminal involvement.

Dataset Information

Comparing opium tincture and methadone for medication-assisted treatment of patients with opioid use disorder: Protocol for a multicenter parallel group noninferiority double-blind randomized controlled trial.

Publications

Comparing opium tincture and methadone for medication-assisted treatment of patients with opioid use disorder: Protocol for a multicenter parallel group noninferiority double-blind randomized controlled trial.

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