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Comparing Opium Tincture (OT) With Methadone for Substitution Treatment of Opioid Dependence

Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid Dependence

Intervention: opium (Drug); methadone (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: University of British Columbia

Official(s) and/or principal investigator(s):
Michael R Kausz, MD, PhD, FRCPC, Principal Investigator, Affiliation: University of British Columbia
Shahin Akhondzadeh, PhD.FBPharmacols., D. Sc., Principal Investigator, Affiliation: Tehran University of Medical Sciences

Overall contact:
Mohammadali Nikoo, MD, Phone: 1 604-827-3975, Email: mnikoo@cheos.ubc.ca


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.

Clinical Details

Official title: Comparison of Opium Tincture (OT) and Methadone for Maintenance Treatment of Opioid Dependence: A Randomized Double-blind Controlled Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: retention in treatment

Secondary outcome:


Withdrawal symptoms

physical health

mental health

cognitive function

severity of substance use problem

quality of life

Client Satisfaction


adverse events

Cost- effectiveness

Detailed description: Purpose: To compare the efficacy and safety of opium tincture (OT) with methadone syrup for maintenance treatment of individuals with opioid-dependence. Justification: 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. Research methods: 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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Opioid dependence as confirmed by DSM V diagnostic criteria

- Willingness and ability to adhere to study protocol and follow-up schedule as

determined through the pre-randomization period

- Provide written informed consent.

- Females of childbearing capacity must agree to use an acceptable method of birth

control approved by the study investigator throughout the study. Exclusion Criteria:

- Active participant in another treatment program for opioid dependence within 14 days

before inclusion in the study

- Severe hepatic impairment (decompensated liver disease), a contraindication for

methadone and its potential to precipitate hepatic encephalopathy.

- Hypersensitivity to methadone syrup or other ingredients in the formulation

- Pregnancy

- Severe chronic respiratory disease

- Head injury and raised intracranial pressure: Respiratory depressant effects (with

CO2 retention and secondary elevation of CSF pressure) may be markedly exaggerated in the presence of head injury, or a preexisting increase in intracranial pressure. May produce effects that obscure the clinical course in participants with head injuries.

- Biliary tract disease: may cause constriction of sphincter of Oddi.

- Monoamine oxidase inhibitors use within 14 days of the study

Locations and Contacts

Mohammadali Nikoo, MD, Phone: 1 604-827-3975, Email: mnikoo@cheos.ubc.ca

Roozbeh substance use treatment clinic, Tehran, Iran, Islamic Republic of; Not yet recruiting
Afshar Amiri, MD, Phone: +989124246437, Email: amiriafshar@yahoo.com
Amir Hooshang Bagheri Valoojerdi, MD, Phone: +989122191051, Email: drahbagheri@gmail.com
Amir Hooshang Bagheri Valoojerdi, MD, Principal Investigator
Additional Information

Starting date: September 2015
Last updated: July 16, 2015

Page last updated: August 23, 2015

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