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Opioid-dependent patients seeking maintenance treatment will be recruited. Each participant will be allocated to one of the two study groups with the equal chance of receiving either opium tincture or methadone. Participants, clinical and research staff will not be aware of the medication that each patient receives. This study aims to test whether opium tincture is equally effective as methadone at retaining participants with opioid dependence in substitution treatment.
To compare the efficacy and safety of opium tincture (OT) with methadone syrup for maintenance treatment of individuals with opioid-dependence.
Currently, methadone is the gold standard for maintenance treatment of opioid use disorder. Opium tincture (OT) could be a potential new treatment alternative for opioid dependence disorder, and a promising solution to address the following issues:
1. Alternative treatment option As no single treatment is effective for all individuals with opioid dependence, sufficiently diverse treatment options should be available. Currently, treatment options for opioid dependence is not always effective in addressing the addiction, neither after treatments which are offered based on clients' choice, nor even after the current gold standard substitution drug, methadone.
2. Avoidance of overdose with methadone:
The long-acting nature of methadone, its narrow therapeutic window, its high potency and associated lack of standard conversion ratio from and to other drugs, could result in fatal overdose. In contrast, OT has a shorter half-life and lower potency compared to methadone, which can account for a lower incidence of fatal overdose, especially in patients at higher risk of overdose with currently prescribed medications. Thus, OT could be an added treatment option to current available treatments such as Buprenorphine/ Naloxone for maintenance treatment of patients with higher risk of overdose.
3. Prolonged QT syndrome of methadone:
Maintenance treatment with methadone can cause serious, potentially fatal adverse effects on the cardiac electrical conduction system leading to a prolonged QT interval and predisposing patients to arrhythmias. As such, cardiac conduction co-morbidity is a (relative) contraindication for the use of methadone as a maintenance treatment. Thus, OT could be an added treatment option to current available treatments such as buprenorphine or levomethadone for maintenance treatment of patients with cardiac conduction defects.
4. Opium dependence pattern of substance use To date, studies on maintenance treatment of opioid dependence have mostly been carried out on populations in which heroin is the predominant substance of use and there is comparatively fewer data on opium dependent patients. Opium tincture could be the treatment of choice in geographic areas with higher prevalence of opium dependence as the predominant pattern of substance use, such as Iran and some other Asian countries.
5. Traditional medicine and cultural acceptance: Being a traditional herbal remedy for pain, opium tincture appears to be a more culturally acceptable alternative to methadone in some parts of Southeast Asia.
6. Cost effectiveness: Possible cost effectiveness of OT for treatment of opioid use disorder can make it a potential treatment of choice if its efficacy and safety profile could be demonstrated through this RCT.
recruitment strategy: Following methods will be used to recruit participants: 1) Brochures and flyers will be distributed in community outreach, general and mental hospitals, NGO-run communities, colleges and universities, drop-in centers and specialized clinics for treatment of participants with HIV and hepatitis C 2) Posters (same content as a brochures and flyers) of the study will be stuck in the billboard of bus/subway, local stores, hospitals, NGO-run communities, colleges and universities, as well as any specialized health-care center for psychiatry or addiction treatments 3) there are two main NGO-run communities in Tehran for treating opiate dependent patients in Tehran. Investigators will use the initial contact letter to recruit from new patients attending these communities for receiving treatment.
Sample size: Sample size calculation is based on non-inferiority design. In this study, investigators aim to evaluate if OT is no less effective in terms of retention (the primary outcome) than the gold standard, methadone. Previous clinical trials with methadone's 3- month retention rate as their primary outcome, demonstrated a rate of approximately 80%. Setting the type Ι error of 0.05 and power of 80% with clinically acceptable margin of 10%, the calculated sample size equals 100 participants in each treatment group. Considering a dropout rate of 20%, total sample size will be 240, 120 participants randomized to each group of the study. Statistical analysis plan: Retention in treatment will be compared between two groups using Fisher's exact test considering P value ≤ 0.05 as significant. Secondary outcomes will be compared between two groups using Fisher's exact test, independent samples T-test and One-way ANOVA test where applicable. Prediction of outcome variables will be based on generalized linear model and generalized estimating equations (GEE) model.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Roozbeh substance use treatment clinic
Iran, Islamic Republic of
Not yet recruiting
University of British Columbia
Published on BioPortfolio: 2015-07-21T12:23:25-0400
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Strong physiological and emotional dependence on OPIUM.
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