Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Phase 2RecruitingNCT05181891

Washington State University205 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

205

Conditions

Alcohol Use Disorder (AUD)Nicotine Use Disorder

Interventions

Contingency ManagementBEHAVIORAL

Incentives for submitting negative-alcohol urine samples

Non-contingent controlBEHAVIORAL

Incentives for submitting urine samples

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Washington State University

Spokane, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Biochemically Verified Alcohol Use

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).

Time frame: 12-week treatment period and 7-month follow-up period

Change in Biochemically Verified Tobacco Use

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).

Time frame: 12-week treatment period and 7-month follow-up period

Secondary Outcomes

Change in Self Reported Alcohol Use

Consumption of alcohol between participants randomized to CM+TAU vs NC+TAU assessed by participant self report (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).

Time frame: 12-week treatment period and 7-month follow-up period

Change in Self Reported Tobacco Use

Consumption of tobacco between participants randomized to CM+TAU vs NC+TAU assessed by participant self report (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).

Time frame: 12-week treatment period and 7-month follow-up period

Central Contacts

Research Coordinator

CONTACT

509-638-2376 wsu.appl@wsu.edu

Data from ClinicalTrials.gov

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