Varenicline as a Treatment for Cannabis Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 224
- 主要终点
- Cannabis use reduction
研究概览
简要总结
Marijuana is the most commonly used illicit drug, and there is a high demand for effective treatments for cannabis use disorder, yet few specific pharmacological treatments have been developed. This study will evaluate the efficacy and safety of varenicline for reducing marijuana use in adults who use marijuana frequently. Participants will be randomized to receive either varenicline or placebo for 12 weeks, along with computerized cognitive behavioral therapy. Cannabis use, medication adherence, and safety outcomes will be assessed throughout treatment and at a follow-up visit.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •DSM-5 diagnosis of cannabis use disorder
- •Cannabis use ≥ 3 days per week in past 30 days
- •Ability to read English and provide informed consent
- •Willingness to comply with medication and study procedures
- •Agreement to use acceptable contraception if of childbearing potential
排除标准
- •Pregnant, breastfeeding, or planning pregnancy
- •Severe renal impairment (CrCl < 30 mL/min)
- •Lifetime bipolar I or II disorder, schizophrenia, or other psychotic disorder
- •Suicidal ideation or behavior within 6 months
- •Use of excluded psychotropic medications (e.g., bupropion, nortriptyline)
- •Moderate or severe non-cannabis substance use disorder (except nicotine)
- •Clinically significant cardiovascular or cerebrovascular disease in past 6 months
- •Hypersensitivity to varenicline
- •Participation in another investigational drug study within 30 days
研究组 & 干预措施
Placebo
Matched placebo administered daily for 12 weeks.
干预措施: Placebo (Drug)
Varenicline
Varenicline will be provided at the standard recommended dose of 0.5mg daily for three days, then 0.5mg twice daily for four days, and then 1mg twice daily for the remainder of the 12-week treatment period.
干预措施: Varenicline (Chantix) (Drug)
结局指标
主要结局
Cannabis use reduction
时间窗: Weeks 6-12
The primary efficacy outcome is cannabis use reduction as measured by daily substance use logs and examined as the total number of use sessions at each weekly visit.
Group equivalence
时间窗: Weeks 6-12
There will equivalence of the average number of weekly use sessions reported between men and women.
Treatment responder classification
时间窗: Weeks 6-12
Determine what baseline demographic, cannabis use, and clinical characteristics best differentiate positive study treatment responders as compared to non-responders .
次要结局
未报告次要终点
研究者
Aimee McRae-Clark
Professor-Faculty
Medical University of South Carolina