Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 538
- 试验地点
- 12
- 主要终点
- Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens
研究概览
简要总结
The primary objective of this study is to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence.
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
- 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
- •Clinical diagnosis of cocaine/methamphetamine dependence
- •Smoked cigarettes for at least 3 months
- •Currently smoking > 6 cigarettes/day
- •Have an interest in quitting smoking
- •Enrolled in outpatient treatment at a participating site
排除标准
- •Clinical diagnosis of current alcohol or sedative dependence, bipolar disorder; or a life-time diagnosis of anorexia nervosa or bulimia
- •Seeking/receiving treatment for opiate-agonist replacement therapy
- •Medical conditions that could compromise participant safety
- •Taking medications with known/potential interactions with bupropion
- •Hypersensitivity to bupropion, nicotine, or menthol
- •Pregnant or breastfeeding
- •Abnormal ECG
- •Recent smoking cessation treatment
- •Use of tobacco products other than cigarettes in the past week
- •Likely to enter residential/inpatient treatment within 10 weeks
- •Have all stimulant-positive urine drug screens during screening/baseline
研究组 & 干预措施
Smoking-cessation treatment + substance treatment as usual
干预措施: Smoking-cessation treatment (Other)
Substance-treatment as usual
Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
结局指标
主要结局
Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens
时间窗: Week 16
Stimulant-free week results (no cocaine, methamphetamine and amphetamine use) were obtained by combining the urine drug screens (UDS) and the self-reported Timeline Follow-Back (TLFB). At the group level, this outcome translates into the percentage of weeks in each study arm that are stimulant-free.
次要结局
- Stimulant-free Results at 6-month Visit(6 - months follow-up visit)
- Point-prevalence Abstinence (Smoking Outcome)(Week 10 assessment)
- Four Week Continuous Smoking Abstinence(Post-quit days 15-42)
- Stimulant-free Results at 3-month Visit(3-month follow-up visit)
- Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit(3- month follow-up visits)
- Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit(6 month visit)
研究者
Theresa Winhusen
Professor; Director, Center for Addiction Research
University of Cincinnati