PERRAS: Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Sponsor

Washington State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05181891

Collaborator

(none)

205

Enrollment

Location

Arms

45.7

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder (AUD) Nicotine Use Disorder	Behavioral: Contingency Management Behavioral: Non-contingent control	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

205 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Phase II randomized trialPhase II randomized trial

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Actual Study Start Date :

Jul 11, 2022

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (CM+TAU) Contingency Management + Treatment as Usual 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.	Behavioral: Contingency Management Incentives for submitting negative-alcohol urine samples
Active Comparator: (NC+TAU) No Contingency + Treatment as Usual 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.	Behavioral: Non-contingent control Incentives for submitting urine samples

Arm

Intervention/Treatment

Experimental: (CM+TAU) Contingency Management + Treatment as Usual

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.

Behavioral: Contingency Management

Incentives for submitting negative-alcohol urine samples

Active Comparator: (NC+TAU) No Contingency + Treatment as Usual

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.

Behavioral: Non-contingent control

Incentives for submitting urine samples

Outcome Measures

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Attended at least 4 of 6 possible visits during the induction period.

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.