Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date
研究概览
简要总结
The objective of the proposed project is to develop a novel, behavioral approach to smoking cessation that can be integrated with residential drug use treatment for low income substance using smokers with elevated depressive symptoms. The approach utilizes behavioral activation strategies which have been shown to reduce smoking among community samples and which can be easily targeted for the particular needs of low income substance users.
详细描述
This project will take place in two phases. In the first phase, the investigators will utilize pilot testing with 10 participants (two groups of 5 individuals) to integrate two existing behavioral activation manuals to develop the Behavioral Activation for Drug Abusing Smokers (BA-DAS). In Phase II, the investigators will randomize 80 patients to either: 1) standard smoking cessation treatment (ST) and nicotine replacement therapy (NRT) or 2) BA-DAS (which includes ST and NRT). Based on the outcome of this preliminary trial, the BA-DAS protocol will be further refined and readied for larger-scale clinical trials to develop a comprehensive approach to treating smoking among low income, largely minority, depressed smokers in residential drug use treatment, which may be instrumental in reducing smoking among this especially at risk group.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 and 65 years of age
- •regular smoker for at least one year
- •currently smoking an average ≥ 10 cigarettes (also cigarellos, bidis, or Black and Milds included) per day
- •report motivation to quit smoking in the next month
- •report elevated depressive symptoms
排除标准
- •physical concerns contraindicating the nicotine patch
- •limited mental competency and/or the inability to give informed, voluntary, written consent to participate
- •current use of pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
- •use of psychotropic medication for < 3 months
- •primary use of other tobacco products (specifically: chewing tobacco, cigars, and pipes)
- •psychotic symptoms
- •current pregnancy or plans to become pregnant within the following three months
研究组 & 干预措施
Standard smoking cessation
Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
干预措施: Standard Treatment (Behavioral)
Standard smoking cessation
Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
干预措施: Transdermal Nicotine Patch (Drug)
BA for substance abusing smokers
The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
干预措施: BAD-AS (Behavioral)
BA for substance abusing smokers
The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
干预措施: Transdermal Nicotine Patch (Drug)
结局指标
主要结局
Number of Participants Smoking-Abstinent for 7 Days, 26 Weeks Post Quit Date
时间窗: 26 weeks post quit date
7 days of smoking abstinence confirmed biochemically at 26 weeks
次要结局
未报告次要终点
研究者
Laura MacPherson
Dr. Laura MacPherson
University of Maryland, College Park