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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-week treatment period and 7-month follow-up period
Awards & highlights

PERRAS Trial 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.Check my eligibility
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.See study design
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.

PERRAS Trial 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.

PERRAS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Biochemically Verified Alcohol Use
Change in Biochemically Verified Tobacco Use
Secondary outcome measures
Change in Self Reported Alcohol Use
Change in Self Reported Tobacco Use

PERRAS 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
2003
Completed Phase 2
~3220

Find a Location

Who is running the clinical trial?

Washington State UniversityLead Sponsor
101 Previous Clinical Trials
56,509 Total Patients Enrolled
7 Trials studying Alcoholism
1,286 Patients Enrolled for Alcoholism
Sterling M McPherson, PhDPrincipal InvestigatorWashington State University

Media Library

Contingency Management (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05181891 — Phase 2
Alcoholism Research Study Groups: (NC+TAU) No Contingency + Treatment as Usual, (CM+TAU) Contingency Management + Treatment as Usual
Alcoholism Clinical Trial 2023: Contingency Management Highlights & Side Effects. Trial Name: NCT05181891 — Phase 2
Contingency Management (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05181891 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are enrolled in this clinical research project?

"That is accurate. The information available on clinicaltrials.gov suggests that this research is actively recruiting patients as of now. This trial was originally posted on July 11th, 2020 and has been edited since then. They are looking for around 200 participants from a single site."

Answered by AI

Are people currently signing up for this trial?

"Yes, the trial is ongoing and looking for 205 additional patients from a single site. The listings on clinicaltrials.gov show that this study was first posted on 7/11/2022 and has had no updates since then."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
What site did they apply to?
Washington State University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've tried three other drugs it didn't work and trying to figure out a way to cope with my addiction.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
Sterling McPherson 2022. "Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05181891.
~109 spots leftby May 2026
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