NCT05181891PHASE2RecruitingAccepts Healthy Volunteers

Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Washington State University

Start Date

7/11/2022

Completion Date

5/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. 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 2. Seeking AUD treatment 3. Seeking smoking cessation treatment 4. Aged 18+ years 5. DSM-5 diagnosis of AUD 6. Currently smoking daily according to PhenX Smoking Status (100 or more lifetime cigarettes plus current daily smoking) 7. Ability to read and speak English 8. Ability to provide written informed consent 9. Breath alcohol of 0.00 during informed consent 10. 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 11. Attended at least 4 of 6 possible visits during the induction period. Exclusion Criteria: 1. 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 2. Currently receiving any pharmacotherapy for alcohol 3. Currently receiving any pharmacotherapy for smoking 4. No suicide attempt in the last 20 years and 5. Any other medical (discernable by initial blood tests) or psychiatric condition that Drs. Layton or Rodin determine would compromise safe participation.

Interventions

BEHAVIORAL

Contingency Management

BEHAVIORAL

Non-contingent control

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Conditions

Alcohol Use Disorder (AUD)Nicotine Use Disorder

Locations

Washington State University

Spokane, Washington 99202

United States