Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Alcohol Use Disorder (AUD)
- Sponsor
- Washington State University
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Change in Biochemically Verified Tobacco Use
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Sterling McPherson
Professor
Washington State University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in Biochemically Verified Tobacco Use
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
- 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)