Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Alcohol Use Disorder (AUD) Clinical Trial

— PERRAS  

Official title:

Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05181891
• Other study ID #: 18668-001
• Status: Recruiting
• Phase: Phase 2
• Start date: July 11, 2022
• Est. completion date: May 1, 2026

Study information

• Verified date: March 2023
• Source: Washington State University
• Contact: Abigail Bowen, MS
• Phone: (425) 736-1354
• Email: abigail.bowen[@]wsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 205
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder (AUD)
• Alcoholism
• Disease
• Nicotine Use Disorder
• Tobacco Use Disorder

Intervention

Behavioral:
• Contingency Management
Incentives for submitting negative-alcohol urine samples
• Non-contingent control
Incentives for submitting urine samples

Locations

Country	Name	City	State
United States	Washington State University	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12-week treatment period and 7-month follow-up period
Primary	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).	12-week treatment period and 7-month follow-up period
Secondary	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).	12-week treatment period and 7-month follow-up period
Secondary	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).	12-week treatment period and 7-month follow-up period