ASSESSING THE EFFICACY OF A BRIEF MOTIVATIONAL INTERVENTION FOR CANNABIS USE DISORDER
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- 2. Cannabis Problems Questionnaires -- quantifies negative social, occupational, physical and legal consequences of cannabis use across 16 items
研究概览
简要总结
This is a single-blind randomized controlled trial evaluating the efficacy of a Brief Motivational Intervention for Cannabis (BMIC) among adults with Cannabis Use Disorder (CUD). Participants aged 18–65 years meeting DSM-5/ICD-11 criteria for mild to severe CUD will be randomized to receive either BMIC in addition to Treatment-as-Usual (TAU) or TAU alone. The amended protocol (Version 1.2, November 2025), ratified by the Institutional Ethics Committee, refines the primary outcome to reduction in cannabis craving measured using the Brief Substance Craving Scale (BSCS) at Day 14. Secondary outcomes include frequency and quantity of cannabis use assessed by Timeline Follow-Back, withdrawal severity, psychological distress, and urine-verified abstinence at discharge and follow-up. The intervention comprises structured motivational interviewing sessions with booster follow-up, while the control arm receives TAU only. The revised sample size is 100 participants (50 per arm), powered to detect a clinically meaningful change in craving. Participant safety will be monitored throughout the study, and results will be disseminated through peer-reviewed publications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Participants will be recruited from the inpatient and outpatient departments of KIMS, as well as from residential treatment facilities for substance abuse and cannabis.
- •Participants will range in age from 18 to 60 years old.
- •Patients meeting the DSM-5 criteria for moderate to severe cannabis use disorder,the possibility of having co-morbid substance use disorders, and expressing a willingness to participate and remaining accessible for follow-up assessments are all requirements for participants to be eligible for the study.
排除标准
- •Severe mental disorders, organic brain pathology, intellectual disability.
- •Comorbid psychiatric disorders before substance use shall be excluded.
结局指标
主要结局
2. Cannabis Problems Questionnaires -- quantifies negative social, occupational, physical and legal consequences of cannabis use across 16 items
时间窗: Cannabis Problems Questionnaires -- quantifies negative social, occupational, physical and legal consequences of cannabis use across 16 itemss | Drug Toxicology report shall be added for abstinence markers.
次要结局
- Changes in cannabis-related problems, intensity of cannabis craving, withdrawal symptoms, depression, anxiety, stress levels, and perceived social support(at baseline (before the intervention begins), at 4 weeks (mid-intervention), and at 8 weeks (post-intervention). These assessments capture changes over the course of treatment in areas such as cannabis-related problems, craving intensity, withdrawal symptoms, levels of depression, anxiety, stress (via DASS-21), and perceived social support (via MSPSS), as well as abstinence confirmed through urine tests)
研究者
Sidharth Mishra
Kalinga Institute of Medical sciences