Behavioral Treatment for Alcoholism and Tobacco Use Disorder

(PERRAS Trial)

Overseen By Abigail Bowen, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington State University

Must be taking: Varenicline

Must not be taking: Alcohol pharmacotherapy, Smoking pharmacotherapy

Disqualifiers: Dangerous alcohol withdrawal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 21

Duration: 12 weeks

205 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a behavioral treatment called Contingency Management (CM) to assist individuals in reducing alcohol use and quitting smoking. Participants will be randomly assigned to one of two groups: one will receive CM along with the usual treatment, while the other will receive only the usual treatment. The goal is to determine if CM can more effectively reduce drinking and smoking compared to standard treatment alone. The trial seeks individuals who have recently been drinking heavily, wish to quit smoking, and are currently seeking treatment for both issues. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that contingency management (CM) is an effective method for treating substance use disorders. Studies have demonstrated its success in helping individuals avoid drugs and alcohol by using rewards to motivate them to remain substance-free.

CM does not involve medication or physical treatments, so it does not cause direct physical side effects. It focuses on changing behavior and boosting motivation, making it a generally safe option for participants.

Varenicline (VC) is already FDA-approved to help people quit smoking. Previous studies found that while varenicline is usually well-tolerated, some individuals might experience side effects like nausea, headaches, or trouble sleeping. Discussing any concerns with a healthcare provider is important, especially if there are existing health conditions.

Overall, combining CM and varenicline has a strong track record of aiding addiction recovery, with the main consideration being how well a person can handle varenicline's side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Contingency Management (CM) in treating alcoholism and tobacco use disorder because it offers a unique behavioral approach that reinforces positive actions. Unlike traditional treatments that primarily rely on medication alone, CM combines standard care with motivational incentives. Participants receive rewards for providing urine samples that test negative for alcohol, encouraging abstinence through positive reinforcement. This approach aims to engage participants actively in their recovery process, potentially leading to better adherence and outcomes compared to standard treatments like nicotine replacement therapy or counseling alone.

What evidence suggests that contingency management is effective for decreasing alcohol use and cigarette smoking?

Research has shown that Contingency Management (CM), which participants in this trial may receive, effectively treats various substance use problems. Studies have found that CM is particularly helpful in encouraging individuals to stop using substances like cocaine, opioids, and cannabis. This method involves rewarding individuals who remain substance-free, which has proven to increase motivation and decrease substance use. Many years of research support CM's success in helping people avoid drugs and alcohol, suggesting it could also benefit those with alcohol and tobacco use issues. ^{2 3 6 7 8}

Who Is on the Research Team?

Sterling M McPherson, PhD

Principal Investigator

Washington State University

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Contingency Management

Trial Overview 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.

How Is the Trial Designed?

Group I: (CM+TAU) Contingency Management + Treatment as Usual Experimental Treatment 1 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 Usual Active Control 1 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.

Contingency Management is already approved in United States, European Union for the following indications:

Approved in United States as Contingency Management for:

• Substance Use Disorders
• Stimulant Use Disorder
• Methamphetamine Use Disorder

Approved in European Union as Contingency Management for:

• Substance Use Disorders
• Addiction Treatment

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

Published Research Related to This Trial

A study involving 120 cocaine-abusing outpatients showed that a low-cost prize reinforcement contingency management (CM) intervention significantly increased abstinence rates, especially in patients receiving up to $240 in potential rewards compared to standard treatment.

Patients who started treatment with positive urine tests responded best to the CM intervention, indicating that the effectiveness of prize reinforcement may depend on the severity of the patient's condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prize reinforcement contingency management for treating cocaine users: how low can we go, and with whom? Petry, NM., Tedford, J., Austin, M., et al.[2018]

In a study involving 142 outpatients with cocaine or heroin dependence, both voucher and prize-based contingency management (CM) interventions led to longer treatment retention and greater durations of confirmed abstinence compared to standard treatment.

While there were no significant differences in abstinence rates at 6- and 9-month follow-ups, the duration of abstinence achieved during treatment was the strongest predictor of continued abstinence after treatment ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. Petry, NM., Alessi, SM., Marx, J., et al.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining implementation of contingency management in real-world settings. Rash, CJ., Alessi, SM., Zajac, K.[2021]

In a study involving 81 nicotine-dependent smokers, the addition of prize-based contingency management (CM) to standard care significantly reduced smoking during treatment compared to standard care alone.

However, these reductions in smoking did not persist after the treatment ended, indicating that while prize CM can be effective in the short term, it may not lead to long-term cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prize contingency management for smoking cessation: a randomized trial. Ledgerwood, DM., Arfken, CL., Petry, NM., et al.[2022]

A portable contingency management (CM) system using cellphones and breathalyzers was tested with 30 adults, showing that 88.6% of breath alcohol concentration (BrAC) tests were submitted on time, indicating high feasibility for this method.

Participants receiving CM had a higher percentage of negative BrAC results and longer durations of abstinence, along with reduced drinking frequency and related problems, demonstrating the initial efficacy of this approach in addressing alcohol use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment. Alessi, SM., Petry, NM.[2022]

Incentive and contingency management strategies have shown effectiveness in modifying smoking behavior, particularly in controlled settings, suggesting they can be beneficial for smoking cessation efforts.

Quit-and-win programs, which use incentives to encourage quitting, attract many participants and have produced modest quit rates, although the quality of evaluations varies and more rigorous studies are needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incentives in smoking cessation: status of the field and implications for research and practice with pregnant smokers. Donatelle, R., Hudson, D., Dobie, S., et al.[2006]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of contingent prizes versus vouchers in cocaine-using methadone patients. Petry, NM., Alessi, SM., Hanson, T., et al.[2021]

In a study of 42 alcohol-dependent veterans, those who received contingency management (CM) alongside standard treatment had a much higher retention rate in treatment (84%) compared to those receiving only standard treatment (22%).

By the end of the 8-week treatment period, 69% of CM participants remained abstinent from alcohol, while 61% of those in standard treatment had relapsed, indicating that CM is an effective strategy for promoting abstinence in alcohol treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Give them prizes, and they will come: contingency management for treatment of alcohol dependence. Petry, NM., Martin, B., Cooney, JL., et al.[2022]

In a study involving 34 individuals with Cocaine Use Disorder, larger fixed incentives for providing negative urine samples led to faster and more effective abstinence compared to smaller incentives.

The type of incentive structure (escalating and resetting vs. fixed) did not significantly impact the overall effectiveness, suggesting that the magnitude of the incentive is more crucial for promoting abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. Regnier, SD., Strickland, JC., Stoops, WW.[2023]

In a 16-week study involving 12 cocaine-dependent methadone patients, cash-based incentives of $50 and $100 significantly increased short-term cocaine abstinence compared to a control condition with no incentives.

The study found that cash-based incentives did not lead to increased cocaine use after receiving the incentives, suggesting they are a safe option for improving treatment outcomes in substance abuse interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management in cocaine abusers: a dose-effect comparison of goods-based versus cash-based incentives. Vandrey, R., Bigelow, GE., Stitzer, ML.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6095117/

A review of contingency management for the treatment ... A review of contingency management for the treatment of substance-use disorders: adaptation for underserved populations, use of experimental technologies,

2. recoveryanswers.org recoveryanswers.org/resource/contingency-management/

Contingency Management (CM) In the 1990s, dozens of studies showed Contingency Management is a helpful intervention for increasing abstinence among individuals with cocaine use disorder.

3. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/a0cc6fcdb2968be95f60bb1c2c94eb70/contingency-management-sub-treatment.pdf

Contingency Management for the Treatment of Substance ... CM has three decades of research demonstrating its long-term efficacy for treating a variety of SUDs, including stimulant, opioid, cannabis, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12280170/

Financial Incentives for Substance Abstinence Financial incentives (FI) are a promising tool to promote health behavior change, including substance abstinence. We aim to address a 10-year gap in the ...

5. library.samhsa.gov library.samhsa.gov/sites/default/files/contingency-management-advisory-pep24-06-001.pdf

contingency-management-advisory-pep24-06-001.pdf Contingency management (CM) is a proven health care intervention with demonstrated effectiveness in treating a variety of substance use disorders (SUDs) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2866424/

Motivational Incentives Research in the National Drug ... This paper reviews one such line of research, that investigating the impact of abstinence-contingent incentives on the clinical outcomes of stimulant abusers.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820672

Financial Incentives for Smoking Cessation Among ... Contingency management, the tangible reinforcement of abstinence and related outcomes, is effective for promoting drug and alcohol abstinence ...

8. legislativeanalysis.org legislativeanalysis.org/wp-content/uploads/2023/10/Contingency-Management-Fact-Sheet-FINAL.pdf

Contingency Management Fact Sheet Contingency management is a well-studied and effective method for treating substance use disorder, but for years, it received little support in the United ...