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Behavioural Intervention

Behavioral Treatment for Alcoholism and Tobacco Use Disorder (PERRAS Trial)

Phase 2

Recruiting

Led By Sterling M McPherson, PhD

Research Sponsored by Washington State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18+ years

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

Must not have

Currently receiving any pharmacotherapy for alcohol

Currently receiving any pharmacotherapy for smoking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-week treatment period and 7-month follow-up period

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate whether an evidence-based behavioral treatment can decrease alcohol use and cigarette smoking among people with an alcohol use disorder who are trying to quit smoking.

Who is the study for?

This trial is for adults over 18 who smoke daily, are seeking treatment for both smoking and alcohol use disorder (AUD), and have had a certain level of drinking in the past month. They must not be on any current medication for smoking or AUD, have no major medical or psychiatric conditions that could affect safety, and should not be at high risk of severe alcohol withdrawal.

What is being tested?

The study tests if contingency management (CM), a behavioral treatment, can reduce alcohol use and cigarette smoking among those starting varenicline (VC) for quitting smoking. Participants are randomly assigned to either CM or a non-contingent control group to compare outcomes.

What are the potential side effects?

Possible side effects may include those associated with the pharmacotherapy used (varenicline) such as nausea, sleep disturbances, mood changes, headaches, and unusual dreams. Behavioral interventions typically do not have physical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I've had 4+ (women)/5+ (men) drinks at once, 4 times in the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for alcohol use.

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I am currently taking medication to help me stop smoking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-week treatment period and 7-month follow-up period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-week treatment period and 7-month follow-up period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-week treatment period and 7-month follow-up period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Biochemically Verified Alcohol Use

Change in Biochemically Verified Tobacco Use

Secondary study objectives

Change in Self Reported Alcohol Use

Change in Self Reported Tobacco Use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: (CM+TAU) Contingency Management + Treatment as UsualExperimental Treatment1 Intervention

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.

Group II: (NC+TAU) No Contingency + Treatment as UsualActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contingency Management

2014

Completed Phase 4

~3440

0 / 4Eligibility criteria met