Contingent Vouchers for Smoking in Substance Abusers as Adjunct to Nicotine Patch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Number of Participants Smoking Abstinent in Past 7 Days
研究概览
简要总结
The aim of this study is to determine whether contingent reinforcement for smoking abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment.
详细描述
Substance abusers have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking.
The aim of this study is to determine whether contingent reinforcement for smoking abstinence (CM), compared to noncontingent reinforcement (NR), increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment. The proposed study will be a 2-group design in which up to 274 substance abusers who smoke 10 or more cigarettes per day receive brief advice (4 sessions) and nicotine replacement (NRT) (8 weeks), and are randomized to 19 days of CM for smoking vs. a matched NR condition. The brief advice is adapted slightly for sobriety settings. Point-prevalence abstinence will be assessed at 1, 3, 6 and 12 months after starting treatment. Secondary aims evaluate effects of CM on substance use outcomes and potential mediators of effects on outcome, including within-treatment abstinence, motivation level and tolerance for smoking discomfort.
The significance is to add knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this population.
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
- •diagnosis of substance abuse or dependence by DSM-IV criteria
- •in residential treatment at one particular agency
- •currently smoking at least 10 cigarettes per day for the past 6 months
排除标准
- •hallucinating or delusional or marked organic impairment (to the point of impairing ability to understand informed consent) according to medical records
- •current use of nicotine replacement therapy, Zyban, or any other smoking cessation treatment
- •medical exclusions for NRT: pregnant or nursing; treatment in the last 3 months for unstable angina, severe congestive heart failure, uncontrolled hypertension; lung cancer; supplemental oxygen; history of adverse reactions to NRT; allergies to adhesive; or any severe skin disease that requires treatment (e.g., psoriasis or eczema).
研究组 & 干预措施
Contingency Management (CM)
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
干预措施: Nicotine Replacement Treatment (NRT) (Drug)
Contingency Management (CM)
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
干预措施: Brief Advice (Behavioral)
Contingency Management (CM)
Condition provides contingent monetary reinforcement for smoking reductions (first 5 days) then for smoking abstinence (subsequent 14 days). Expired carbon monoxide (CO) levels will be the basis for determining reductions and abstinence.
干预措施: Contingency Management (Behavioral)
Noncontingent Reinforcement (NR)
Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained.
干预措施: Nicotine Replacement Treatment (NRT) (Drug)
Noncontingent Reinforcement (NR)
Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained.
干预措施: Brief Advice (Behavioral)
Noncontingent Reinforcement (NR)
Controls for effects of receiving payments, providing daily breath samples for CO level, and degree of interaction between patient and research staff. NR will allow them to earn an amount which is matched in amount to the expected average earned in CM contingent only on providing breath samples independent of the CO level attained.
干预措施: Non-Contingent Reinforcement (Behavioral)
结局指标
主要结局
Number of Participants Smoking Abstinent in Past 7 Days
时间窗: 12-month follow up
7 -day smoking cessation confirmed by expired alveolar CO levels of \< 10 ppm or salivary cotinine \< 16 ng/ml.
Average Number of Cigarettes Per Day
时间窗: 12-month follow up
Number of Participants With Relapse to Any Heavy Drinking
时间窗: 12-month follow up
Heavy drinking = 6 or more drinks for men; 5 or more drinks for women
Number of Participants With Relapse to Any Drug Use
时间窗: 12-month follow up
Percent Smoking Days
时间窗: 12-month follow up
次要结局
未报告次要终点
研究者
Damaris J. Rohsenow, Ph.D.
Professor (Research): Behavioral and Social Sciences
Brown University