Feasibility and Preliminary Effectiveness of Varenicline for Co-occurring Cannabis and Tobacco Use
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 主要终点
- Enrollment Rate
研究概览
简要总结
Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance abuse treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use.
详细描述
Treating co-occurring cannabis and tobacco use disorders might reduce the health burdens associated with both substances. However, few studies have evaluated pharmacological interventions, in combination with behavioral treatment, to address co-occurring cannabis and tobacco use; these are limited by high participant attrition, poor adherence to interventions, and lack of control. Participants were recruited from an urban, outpatient substance abuse treatment program that offers both intensive behavioral counseling and medication-assisted treatment (MAT) for opioid use disorder. The investigators selected these clinical sites because the investigators have successfully recruited and retained participants from these sites in prior clinical trials, and anticipated that they would find a high prevalence of persons with frequent cannabis use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Able to speak English
- •Uses cannabis at least 5 days in the past 7 days
- •Current or former tobacco smoker
- •Has not taken varenicline in the past 30 days
- •Not pregnant, trying to conceive or breastfeeding
- •Able to provide informed consent
- •Test positive for cannabinoids by urine toxicology
排除标准
- •Unstable medical or psychiatric illness
- •Opioid use disorder was initially exclusionary but eligibility criteria were revised after 32 individuals were screened to facilitate recruitment.
研究组 & 干预措施
Standard clinical care first, followed by standard clinical care and varenicline
Four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program. SCC includes individual counseling, at least once a month, that uses motivational and cognitive behavioral strategies, may address cannabis or tobacco use, and is delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).
This is followed by four weeks of SCC plus varenicline treatment (SCC and VT). Varenicline treatment included a gour-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days.
干预措施: Standard clinical care first, followed by standard clinical care and varenicline (Drug)
Standard clinical care and varenicline first, followed by standard clinical care
Four weeks of standard clinical care (SCC) plus varenicline treatment (SCC and VT). SCC includes individual counseling, at least once a month, that uses motivational and cognitive behavioral strategies, may address cannabis or tobacco use, and is delivered by trained substance use disorder treatment counselors; and medications for opioid use disorder (MOUD).Varenicline treatment included a gour-week supply of standard doses: 0.5mg for the first three days, 0.5mg twice a day for the following four days, and 1 mg twice a day for the remaining 21 days.
This is followed by four weeks of SCC in an outpatient substance use disorder treatment program, as described above.
干预措施: Standard clinical care and varenicline first, followed by standard clinical care (Drug)
结局指标
主要结局
Enrollment Rate
时间窗: Baseline
Percentage of the eleven eligible subjects willing to participate
次要结局
- Retention Rate(Week 8)
- Overall Medication Adherence(Upon conclusion of SCC+Varenicline treatment (4 weeks or 8 weeks based on randomization to arm/group))
- Number of Participants With Treatment-Emergent Adverse Events: Upset Stomach(Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group))
- Number of Participants With Treatment-Emergent Symptoms of Major Depressive Disorder(Upon conclusion of SCC+VT treatment (4 weeks or 8 weeks based on randomization to arm/group))
- Cannabis Craving(Week 4 and Week 8)
- Cannabis Withdrawal(Week 4 and Week 8)
- Quantity of Cannabis Use(Week 4 and Week 8)
- Frequency of Cannabis Use(Week 4 and Week 8)
- Number of Cigarettes Smoked Per Day(Week 4 and Week 8)
- Number of Participants With Toxicology-verified Cannabis Abstinence(Week 4 and Week 8)
- Number of Participants With Biochemically-verified Tobacco Abstinence(Week 4 and Week 8)
- Mean Expired Carbon Monoxide(Week 4 and Week 8)
- Number of Participants With Treatment-Emergent Suicidal Ideation Events(Week 4 and Week 8)