~55 spots leftby May 2026

Behavioral Treatment for Alcoholism and Tobacco Use Disorder

(PERRAS Trial)

Recruiting in Palo Alto (17 mi)
SM
Overseen bySterling M McPherson, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Washington State University
Must be taking: Varenicline
Must not be taking: Alcohol pharmacotherapy, Smoking pharmacotherapy
Disqualifiers: Dangerous alcohol withdrawal, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you are not currently receiving any medication for alcohol or smoking. If you are on such medications, you would need to stop them to participate.

What data supports the effectiveness of the treatment Contingency Management, Motivational Incentives, Prize Method, Carrot and Stick Method for alcoholism and tobacco use disorder?

Research shows that using prize-based contingency management (a system of rewards) can help people quit smoking and stay off drugs like cocaine and heroin. In one study, alcohol-dependent individuals who had the chance to win prizes were more likely to stay in treatment compared to those who did not have this incentive.12345

Is contingency management safe for treating substance use disorders?

Research on contingency management, which uses rewards to encourage positive behavior, suggests it is generally safe for treating substance use disorders. Studies have shown it can be effective without causing harm, even when using cash-based incentives, although more research is needed to confirm these findings in larger groups.24678

How does the Contingency Management treatment for alcoholism and tobacco use disorder differ from other treatments?

Contingency Management is unique because it uses tangible rewards, like prizes, to encourage abstinence from alcohol and tobacco, making it different from other treatments that may not use incentives. This approach has been shown to improve treatment retention and promote longer periods of abstinence by providing immediate, positive reinforcement for desired behaviors.125910

Research Team

SM

Sterling M McPherson, PhD

Principal Investigator

Washington State University

Eligibility Criteria

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.

Inclusion Criteria

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
I've had 4+ (women)/5+ (men) drinks at once, 4 times in the last month.
Attended at least 4 of 6 possible visits during the induction period
See 8 more

Exclusion Criteria

No suicide attempt in the last 20 years
Any other medical (discernable by initial blood tests) or psychiatric condition that Drs. Layton or Rodin determine would compromise safe participation
I've had severe alcohol withdrawal or seizures recently and am worried about withdrawal.
See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varenicline and participate in contingency management or control conditions for reducing alcohol and smoking

12 weeks
3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months
Visits at weeks 18, 30, and 42 (in-person)

Treatment Details

Interventions

  • Contingency Management (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Washington State UniversitySpokane, WA
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Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials
114
Recruited
58,800+

Dr. Mangiardi

Washington State University

Chief Executive Officer

PhD in Biochemistry from Washington State University

Dr. Cindy Jacobs

Washington State University

Chief Medical Officer since 2017

PhD in Veterinary Pathology/Microbiology from Washington State University, MD from University of Washington Medical School

Findings from Research

In a study involving 74 cocaine-dependent methadone outpatients over 12 weeks, both voucher and prize-based contingency management (CM) interventions led to longer durations of abstinence compared to standard treatment.
The study found no significant differences in outcomes between the voucher and prize systems, indicating that both methods are effective in promoting abstinence during treatment, which is linked to better long-term recovery outcomes.
Randomized trial of contingent prizes versus vouchers in cocaine-using methadone patients.Petry, NM., Alessi, SM., Hanson, T., et al.[2021]
A survey of 214 substance use treatment providers revealed that while many clinics are using reward programs, they often do not follow effective practices recommended by research, such as providing higher reward amounts or immediate reinforcement.
Providers with more extensive training in contingency management (CM) were more likely to implement effective strategies, suggesting that better training could improve the quality of reward-based interventions in real-world settings.
Examining implementation of contingency management in real-world settings.Rash, CJ., Alessi, SM., Zajac, K.[2021]

References

Prize contingency management for smoking cessation: a randomized trial. [2022]
Vouchers versus prizes: contingency management treatment of substance abusers in community settings. [2016]
Randomized trial of contingent prizes versus vouchers in cocaine-using methadone patients. [2021]
Examining implementation of contingency management in real-world settings. [2021]
Give them prizes, and they will come: contingency management for treatment of alcohol dependence. [2022]
Incentives in smoking cessation: status of the field and implications for research and practice with pregnant smokers. [2006]
A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. [2023]
Contingency management in cocaine abusers: a dose-effect comparison of goods-based versus cash-based incentives. [2022]
A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment. [2022]
Prize reinforcement contingency management for treating cocaine users: how low can we go, and with whom? [2018]