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

Primary Purpose

Alcohol Use Disorder (AUD), Nicotine Use Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Contingency Management

Non-contingent control

About this trial

This is an interventional treatment trial for Alcohol Use Disorder (AUD) focused on measuring Alcohol Use Disorder, Contingency Management, Incentives for Sobriety, Varenicline, Nicotine Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Washington State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

(CM+TAU) Contingency Management + Treatment as Usual

(NC+TAU) No Contingency + Treatment as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

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).

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).

Full Information

NCT ID

NCT05181891

First Posted

December 7, 2021

Last Updated

March 7, 2023

Sponsor

Washington State University

1. Study Identification

Unique Protocol Identification Number

NCT05181891

Brief Title

Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Acronym

PERRAS

Official Title

Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 11, 2022 (Actual)

Primary Completion Date

May 1, 2026 (Anticipated)

Study Completion Date

May 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder (AUD), Nicotine Use Disorder

Keywords

Alcohol Use Disorder, Contingency Management, Incentives for Sobriety, Varenicline, Nicotine Use Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Phase II randomized trial

Masking

Investigator

Allocation

Randomized

Enrollment

205 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

(CM+TAU) Contingency Management + Treatment as Usual

Arm Type

Experimental

Arm Description

Arm Title

(NC+TAU) No Contingency + Treatment as Usual

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Contingency Management

Intervention Description

Incentives for submitting negative-alcohol urine samples

Intervention Type

Behavioral

Intervention Name(s)

Non-contingent control

Intervention Description

Incentives for submitting urine samples

Primary Outcome Measure Information:

Title

Change in Biochemically Verified Alcohol Use

Description

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

Title

Change in Biochemically Verified Tobacco Use

Description

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 Outcome Measure Information:

Title

Change in Self Reported Alcohol Use

Description

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

Title

Change in Self Reported Tobacco Use

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Abigail Bowen, MS

Phone

(425) 736-1354

abigail.bowen@wsu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sterling McPherson, PhD

Phone

(509) 324-7459

smcpherson05@wsu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sterling M McPherson, PhD

Organizational Affiliation

Washington State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington State University

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abigail L Bowen, MS

Phone

425-736-1354

abigail.bowen@wsu.edu

First Name & Middle Initial & Last Name & Degree

Serena M McPherson, BA

Phone

(509) 590-7689

s.mcpherson@wsu.edu

12. IPD Sharing Statement

Plan to Share IPD

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