Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Phase 2

Recruiting

• Conditions: Alcohol Use Disorder (AUD); Nicotine Use Disorder
• Interventions: Behavioral: Non-contingent control; Behavioral: Contingency Management

• Registration Number: NCT05181891
• Lead Sponsor: Washington State University

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.

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-06
• Study Start: 2022-07-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-22
• Last Update Posted: 2024-06-25
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 205

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(NC+TAU) No Contingency + Treatment as Usual	Non-contingent control	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.
(CM+TAU) Contingency Management + Treatment as Usual	Contingency Management	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.

Primary Outcome Measures

Name	Time	Method
Change in Biochemically Verified Tobacco Use	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	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 Outcome Measures

Name	Time	Method
Change in Self Reported Tobacco Use	12-week treatment period and 7-month follow-up period	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).
Change in Self Reported Alcohol Use	12-week treatment period and 7-month follow-up period	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).

Trial Locations

Locations (1)

Washington State University; 🇺🇸 Spokane, Washington, United States