Comparing Opium Tincture (OT) and Methadone for Medication-assisted Treatment of Opioid Use Disorder: A Randomized Double-blind Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 4
- 主要终点
- Retention in treatment
研究概览
简要总结
Patients with opioid use disorder seeking medication-assisted 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 (OT) or methadone. Participants, clinical and research staff will not be aware of the medication that each patient receives. This study aims to test whether OT is as equally effective as methadone at retaining participants with opioid use disorder in medication-assisted treatment.
详细描述
Purpose:
To compare the efficacy and safety of opium tincture (OT) with methadone syrup for medication-assisted treatment of individuals with opioid use disorder.
Justification:
Currently, methadone is the gold standard for medication-assisted treatment of opioid use disorder. Opium tincture could be a potential alternative treatment for this condition, and a promising solution to address the following issues:
- Alternative treatment option As no single treatment is effective for all individuals with opioid use disorder, sufficiently diverse treatment options should be available. Currently, treatment options for opioid use disorder are not always effective.
- Avoidance of overdose with methadone:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Opium
patient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population
干预措施: opium (Drug)
methadone
patient-centered flexible dosing in line with the national protocol published by Iranian Ministry of Health for maintenance treatment of opioid dependent population
干预措施: methadone (Drug)
结局指标
主要结局
Retention in treatment
时间窗: three months
percent of participants retained in the treatment
次要结局
- Mental health(Baseline, month 1, 2 and 3)
- Physical health(Baseline, month 1, 2 and 3)
- Cognitive function(Baseline, month 1, 2 and 3)
- Severity of substance use problem(Baseline, month 1, 2 and 3)
- Client Satisfaction(month 3)
- Abstinence(Baseline, month 1, 2 and 3)
- Craving(Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly)
- Quality of life score from World Health Organization Quality of Life-BREF Questionnaire(Baseline, month 1, 2 and 3)
- Withdrawal symptoms(Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly)
- Adverse events(Day 1-3/ Twice daily | Day 4-14/ Once daily | Day 15-28/ Three times a week | Day 29-84/ Once weekly)
- Cost-effectiveness(three months)
研究者
Michael Krausz
Professor
University of British Columbia