Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking (PERRAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Nicotine Use Disorder; Alcohol Use Disorder (AUD)
• Intervention / Treatment: Behavioral: Contingency Management; Behavioral: Non-contingent control

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 Type: Interventional
• Enrollment (Anticipated): 205
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Abigail Bowen, MS; Phone Number: (425) 736-1354; Email: abigail.bowen@wsu.edu
• Study Contact Backup: Name: Sterling McPherson, PhD; Phone Number: (509) 324-7459; Email: smcpherson05@wsu.edu

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99202
      • Recruiting
      • Washington State University
      • Contact: Serena M McPherson, BA; Phone Number: (509) 590-7689; Email: s.mcpherson@wsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Washington State University
• Investigators: Principal Investigator: Sterling M McPherson, PhD, Washington State University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Anticipated): May 1, 2026
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Contingency Management; Alcohol Use Disorder; Varenicline; Nicotine Use Disorder; Incentives for Sobriety
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Disease; Tobacco Use Disorder
• Other Study ID Numbers: 18668-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No