Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Change in Biochemically Verified Tobacco Use
研究概览
简要总结
Using a randomized controlled trial (RCT), the goal of this study is to evaluate the ability of evidence based behavioral treatment (contingency management: CM) to significantly decrease alcohol use and cigarette smoking among treatment-seeking smokers with an alcohol use disorder (AUD) who have initiated pharmacotherapy (varenicline; VC) for smoking cessation.
详细描述
This randomized, placebo-controlled trial to determine the effectiveness of contingency management for reducing alcohol use and cigarette smoking among adults who want to quit or reduce their co-addiction. Contingency management is a powerful and cost-effective technique that has been used successfully for decades to promote abstinence from benzodiazepines, cocaine, tobacco, etc. Contingency management, and a non-contingent control condition will be used combined with varenicline (VC) and manualized counseling in the form of module videos.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4 or more standard drinks on the same occasion for women (5 or more standard drinks on the same occasion for men) on at least 4 occasions in the prior 30 days
- •Seeking AUD treatment
- •Seeking smoking cessation treatment
- •Aged 18+ years
- •DSM-5 diagnosis of AUD
- •Currently smoking daily according to PhenX Smoking Status (100 or more lifetime cigarettes plus current daily smoking)
- •Ability to read and speak English
- •Ability to provide written informed consent
- •Breath alcohol of 0.00 during informed consent
- •Provision of at least 1 EtG-positive urine test at any time during the induction period and at least one COT-positive urine test at any time during the induction period; and
- •Attended at least 4 of 6 possible visits during the induction period.
排除标准
- •Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal
- •Currently receiving any pharmacotherapy for alcohol
- •Currently receiving any pharmacotherapy for smoking
- •No suicide attempt in the last 20 years and
- •Any other medical (discernable by initial blood tests) or psychiatric condition that Drs. Layton or Rodin determine would compromise safe participation.
研究组 & 干预措施
(CM+TAU) Contingency Management + Treatment as Usual
Varenicline (VC) will be supplied in .5 mg tablets once per week during the active treatment period. During the first week of treatment (Week 3) participants will be instructed to take .5 mg once per day for days 1-3, and 0.5 mg twice per day for days 4-7. The investigators will maintain a target dose of 1mg twice per day for the remaining active treatment period. Additionally, participants will also receive Take Control counseling via video. Participants in CM+TAU will receive reinforcement for submitting urine samples that test negative for recent alcohol use.
干预措施: Contingency Management (Behavioral)
(NC+TAU) No Contingency + Treatment as Usual
Varenicline (VC) will be supplied in .5 mg tablets once per week during the active treatment period. During the first week of treatment (Week 3) participants will be instructed to take .5 mg once per day for days 1-3, and 0.5 mg twice per day for days 4-7. The investigators will maintain a target dose of 1mg twice per day for the remaining active treatment period. Additionally, participants will also receive Take Control counseling via video. NC+TAU will receive reinforcement for submitting any urine sample, regardless of test results.
干预措施: Non-contingent control (Behavioral)
结局指标
主要结局
Change in Biochemically Verified Tobacco Use
时间窗: 12-week treatment period and 7-month follow-up period
Consumption of tobacco between participants randomized to CM+TAU vs NC+TAU assessed by tobacco CO and COT values (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).
Change in Biochemically Verified Alcohol Use
时间窗: 12-week treatment period and 7-month follow-up period
Consumption of alcohol between participants randomized to CM+TAU vs NC+TAU assessed by alcohol EtG values (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).
次要结局
- Change in Self Reported Tobacco Use(12-week treatment period and 7-month follow-up period)
- Change in Self Reported Alcohol Use(12-week treatment period and 7-month follow-up period)
研究者
Sterling McPherson
Professor
Washington State University