Cannabidiol as an Adjunctive Therapy in Opioid Agonist Treatment for Patients with Opioid Dependence An Open-Label Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare the reduction in opioid craving in patients with opioid dependence at baseline, after first between the patients receiving
研究概览
简要总结
Short-term, hospital-based, open-label comparative study designed to assess the effectiveness and safety of adding Cannabidiol (CBD) to standard Opioid Agonist Treatment (OAT) in reducing craving, withdrawal symptoms, and anxiety in individuals with opioid dependence. The study aims to recruit 70 male patients (aged 18-60) diagnosed with Opioid Dependence (ICD-11: 6C43.20). These participants will be randomized into two groups for the 10-day study period: Group 1 (n=35) receiving 800mg CBD plus OAT (T. Buprenorphine 2 mg + T. Naloxone 0.5 mg), and Group 2 (n=35) receiving OAT alone.The core objectives are to compare the reduction in opioid craving, withdrawal symptoms, and anxiety levels between the two groups at five specific time points: baseline, 2 hours post-dose on Day 1, Day 2, Day 3, and on Day 10. A comprehensive set of validated scales will be used for measurement: craving will be assessed by the Heroin Craving Questionnaire-Short Form 14 (HCQ-SF-14), Desire for Drug Questionnaire (DDQ), and Obsessive Compulsive Drug Use Scale (OCDUS); withdrawal severity will be tracked with the Clinical Opioid Withdrawal Scale (COWS); and anxiety will be quantified using the Hamilton Anxiety Rating Scale (HAM-A). The Systematic Assessment for Treatment Emergent Events (SAFTEE) will also be employed to monitor side effects. This research is significant as it seeks to provide formal clinical evidence for CBD in the context of the unique treatment challenges and high prevalence of opioid use in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with opioid dependence, current use (6C43.20) in ICD-
- •Male and females Age : 18-60 year Ability to provide informed consent.
排除标准
- •Patient dependent on any other psychoactive drugs other than nicotine and caffeine.
- •Diagnosis of any Axis I psychiatric condition.
- •Significant medical history or hypersensitivity to cannabinoids.
- •Significant medical or neurological illness including severe cardiovascular, hepatic, renal, anaemia, history of severe head injury or myopathy or untreated thyroid disease.
- •Not willing to give written informed consent.
结局指标
主要结局
To compare the reduction in opioid craving in patients with opioid dependence at baseline, after first between the patients receiving
时间窗: primary outcomes are assessed at baseline, day1 ,day2,day3,and on day10
adjunctive CBD and T. Buprenorphine (2mg) + T. Naloxone (0.5mg) as OAT (Opioid Agonist Therapy),
时间窗: primary outcomes are assessed at baseline, day1 ,day2,day3,and on day10
Vs patents receiving T. Buprenorphine (2mg) + T. Naloxone (0.5mg).
时间窗: primary outcomes are assessed at baseline, day1 ,day2,day3,and on day10
次要结局
- To compare the decline in opioid withdrawal symptoms manifested in patients with opioid dependence(at baseline, post first dose (day 1), second dose (day 2), and third dose (day 3) of CBD and on day 10)
研究者
Dr Arashdeep Singh
Central Institute of Psychiatry, Ranchi