Smoking Cessation Treatment for Substance Use Dependents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes in Smoking Abstinence
研究概览
简要总结
The present research project aims to develop an innovative and empirically validated intervention protocol for smoking cessation among patients with substance use disorders (SUDs). For this purpose, two smoking cessation treatments tailored for SUDs will be assessed. Participants will be assigned to one of the following treatment conditions: 1) Cognitive-behavioral treatment for smoking cessation (CBT) + Episodic Future Thinking (EFT); 2) The same treatment alongside Contingency Management (CM) for shaping abstinence.
The main goals are:
- To analyze the feasibility (e.g., acceptability, compliance) of implementing the abovementioned protocol treatments to a community setting.
- To assess abstinence rates in each treatment condition at short and long-term follow-ups: post-treatment, one, two, three, six and twelve months after post-treatment.
- To assess the effects of smoking abstinence on other substance use.
- To analyze the moderating effect of individual variables over treatment outcomes: sociodemographic characteristics, drug demand, severity of nicotine dependence and SUD, severity of depressive symptomatology and impulsivity.
详细描述
Cigarette smoking continues to have a startling adverse impact on public health, leading to more than 5 million premature deaths annually worldwide. Smoking rates are disproportionately high among the population suffering from substance use disorders (SUDs) (e.g., alcohol or cocaine). In this regard, smokers with comorbid SUD are more likely to smoke heavily and meet criteria for high nicotine dependence. As they experience more difficulty in quitting smoking than their non-SUDs counterparts, they present lower rates of abstinence.
In recent years there has been a great interest in developing effective strategies to promote abstinence in smokers with SUDs. In particular, a proliferation on CM treatments for smokers with SUDs has been recently produced. There is promising evidence for the positive effect of CM treatments upon both quitting smoking and both legal and illegal abuse drugs. On the other hand, CM has shown promising results in promoting both retention and nicotine abstinence among comorbid and non-comorbid smokers. Nevertheless, there is a lack of research exploring the effectiveness of CM on smokers with SUDs.
The primary aim of this clinical trial is to yield data on the effectiveness of CM for smoking cessation in smokers with SUDs. To address this issue, both CBT for smoking cessation plus EFT, and the same treatment alongside CM for shaping abstinence will be assessed. Participants will be randomly assigned to one of the following treatment conditions: 1) CBT+EFT; 2) CBT+EFT+ CM.
In view to assure adequate power for achieving statistical significance, investigators carried out a priori power analysis by using the G*Power 3.1. An estimated sample size of 120 participants would detect a medium effect size (Cohen's d = 0.3, with power (1-β) set at 0.97 and α = 05).
The primary analyses derived from this clinical trial will be conducted using Statistical Package for the Social Science (SPSS) version 24 for Windows. A set of descriptive and frequency analyses will be carried out with regard to participants' characteristics. Comparisons between treatment groups in both baseline characteristics and treatment outcomes will be conducted using a set of chi-square tests for categorical variables and t-tests (two-tailed) for continuous variables.
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
- •Being aged 18 or over.
- •Having smoked 10 or more cigarettes/day within the last year.
- •Meeting the diagnostic criteria for nicotine dependence according to the Diagnostic and Statistical Manual of Mental Disorders-5th ed. (American Psychiatric Association 2013).
- •Undergoing outpatient cocaine or alcohol treatment.
排除标准
- •Not being able to attend the entire treatment.
- •Being currently receiving other psychological/pharmacological treatment for smoking cessation.
- •Being diagnosed with a current severe psychiatric disorder (i.e., schizophrenia,bipolar disorder).
结局指标
主要结局
Changes in Smoking Abstinence
时间窗: End-of-treatment (8-week), 1, 2, 3, 6 and 12 month follow-up
Abstinence is defined as achieving a period of at least 24 hours of abstinence (end-of-treatment) or not smoking since the prior last 7 days. Abstinence is assessed by means of carbon monoxide (CO) and cotinine samples.
Changes in Continuous abstinence
时间窗: 1, 2, 3, 6 and 12 month follow-up since the treatment completion
Abstinence is defined as no smoking (not even a puff) since the participant´s quit day. Abstinence is assessed by means of carbon monoxide (CO) and cotinine samples.
次要结局
- Changes in Depression(Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion)
- Cost Analysis(End of the project when all participant´s data are collected. Data expected: three years after the study onset.)
- Changes in Other Substance Abstinence(End-of-treatment (8-week), 1, 2, 3, 6 and 12 month follow-up since the treatment completion)
- Changes in Drug demand(Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion)
- Changes in Health-Related Quality of Life(Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion)
- Changes in Impulsivity(Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion)
研究者
Roberto Secades-Villa, PhD
Professor, PhD
University of Oviedo