Contingency Management Therapies for Alcoholism

Overseen By Hagar Hallihan, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: AUD medications, Psychoactive drugs

Disqualifiers: Schizophrenia, Bipolar, Psychotic disorders, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

104 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the feasibility \& acceptability of an integrated CM-PST intervention (in K99 phase) and preliminary efficacy (in R00 phase), vs. CM alone, to improve treatment efficacy and inform about neural mechanisms of treatment effects in young adults with Alcohol Use Disorder (AUD). The aims are as follows: K99 Aim: Test feasibility \& acceptability of a developed CM-PST, by meeting these benchmarks: 2a Feasibility: enroll 20 participants in the new CM-PST in a single-arm pre- and post-study, and retain ≥85% at wk 12. 2b Deliver CM-PST at ≥90% fidelity to intervention protocol. 2c Acceptability to participants: Achieve mean score ≥3 on Client Satisfaction Scale Questionnaire and satisfaction from semi-structured interviews. R00 Aim 1) Test preliminary efficacy of CM-PST in a 2-arm pilot RCT: Male/female young adults (aged18-24) who meet AUD criteria will be randomized to CM-PST or CM-only control, and assessed at baseline (0), 3, and 6 months. Primary study endpoint will be 3 months. R00 Aim 2 (Exploratory) Explore potential neural mechanisms of CM-PST effects, by fMRI scanning \& analyses of core regions of the brain circuits regulating positive affect (ventral striatum), negative affect (amygdala), and cognitive control (dorsolateral prefrontal cortex), and connectivity between these core regions.

Will I have to stop taking my current medications?

If you are currently using medications to treat Alcohol Use Disorder (like naltrexone) or psychoactive drugs, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Contingency Management Therapies for Alcoholism?

Research shows that Contingency Management (CM), which uses rewards to encourage abstinence, is effective for treating substance use disorders, including alcohol. Studies suggest that combining CM with other therapies can improve outcomes, making it a promising approach for alcoholism. ^{1 2 3 4 5}

Is Contingency Management therapy safe for humans?

Contingency Management (CM) is generally considered safe as it involves providing incentives to encourage positive behaviors, like abstaining from alcohol or drugs. It has been used successfully in various substance abuse treatments without significant safety concerns. ^{1 2 4 5 6}

How is the CM-PST treatment for alcoholism different from other treatments?

The CM-PST treatment for alcoholism is unique because it combines contingency management (CM), which uses rewards to encourage abstinence, with problem-solving therapy (PST), a type of psychotherapy that helps individuals develop coping strategies. This combination aims to enhance the effectiveness of CM by addressing underlying issues and improving long-term outcomes. ^{1 2 3 5 6}

Research Team

Hagar Hallihan

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for English-speaking young adults aged 18-24 who drink alcohol at least once a week and meet criteria for mild to severe Alcohol Use Disorder (AUD). They must have completed informed consent and a baseline screening visit. Specific details on exclusion criteria are not provided.

Inclusion Criteria

You can speak English.

Initial check-up before starting the study.

You drink alcohol at least once a week and have been diagnosed with a mild, moderate, or severe alcohol use disorder in the past year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Phone screening

K99 Phase

Feasibility and acceptability of CM-PST intervention tested with 20 participants in a single-arm pre- and post-study

12 weeks

8 sessions (4 weekly, 4 bi-weekly) via Zoom

R00 Phase

Preliminary efficacy of CM-PST tested in a 2-arm RCT with follow-up assessments

6 months

Baseline, 3-month, and 6-month assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 3 and 6 months

Treatment Details

Interventions

• CM only
• CM-PST

Trial Overview The study tests an integrated intervention called CM-PST against CM alone, aiming to improve treatment efficacy in AUD. It involves two phases: K99 checks the new method's feasibility and acceptability; R00 compares both methods' effectiveness over six months with primary focus at three months, including brain scans to explore neural mechanisms.

Participant Groups

Group I: Treatment group Experimental Treatment 1 Intervention

For the R00 phase: CM-PST treatment group will receive CM-PST intervention, which will consist of 8 sessions total, delivered remotely via Zoom videoconferences in individual sessions over 12 weeks. The first 4 sessions will be delivered weekly, and the remaining 4 sessions every other week. CM-PST will teach participants problem-solving skills using a structured 5-step method. In addition, participants will receive incentives for alcohol abstinence and submission of urine samples twice/wk. K99 phase participants will also receive CM-PST intervention.

Group II: Control group Experimental Treatment 1 Intervention

For the R00 phase: Participants in CM-only control will receive incentives for alcohol abstinence and submission of urine samples twice/wk. Participant incentives will start at a $10 gift card, with a $5 increase each subsequent measurement point on which alcohol is not detected or reported, to a maximum of $25, but no gift card on days when alcohol use is detected or reported, and the gift card reinforcer value will be re-set to $10.

CM-PST is already approved in United States for the following indications:

Approved in United States as CM-PST for:

• Alcohol Use Disorder (AUD)

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

A systematic review of 12 randomized controlled trials involving 1654 adults found that adding cognitive-behavioral therapy (CBT) or motivational enhancement therapy (MET) to contingency management (CM) did not improve rates of abstinence from substance use at the end of treatment or during follow-up.

The analysis showed no significant benefits in secondary outcomes, such as self-reported days of substance use, indicating that CM alone is as effective as when combined with these psychotherapeutic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving substance misuse outcomes in contingency management treatment with adjunctive formal psychotherapy: a systematic review and meta-analysis. Sheridan Rains, L., Steare, T., Mason, O., et al.[2021]

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]

Contingency management (CM) techniques have a positive average effect size of d = 0.42 in treating substance use disorders, indicating they are effective in promoting abstinence.

CM is particularly effective for opiate (d = 0.65) and cocaine use (d = 0.66), while being less effective for tobacco (d = 0.31), suggesting that the type of substance influences treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for treatment of substance use disorders: a meta-analysis. Prendergast, M., Podus, D., Finney, J., et al.[2022]

In a study involving 393 cocaine-dependent patients, those receiving contingency management (CM) alongside standard care showed significant reductions in psychiatric symptoms over a 9-month follow-up, while those receiving only standard care did not experience similar improvements.

The study found that reductions in drug use were a key factor mediating the positive effects of CM on psychiatric symptoms, indicating that CM not only helps with substance use but also improves overall mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management treatments decrease psychiatric symptoms. Petry, NM., Alessi, SM., Rash, CJ.[2021]

Contingency management (CM) effectively uses positive reinforcement to enhance treatment outcomes for substance abusers, particularly in achieving sustained abstinence from drugs.

CM is not only beneficial as a direct therapeutic approach but also serves as a valuable tool in clinical trials for testing new medications and improving patient adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management: utility in the treatment of drug abuse disorders. Stitzer, ML., Vandrey, R.[2019]

The cost to set up a contingency management (CM) program for treating patients with severe alcohol use disorder and serious mental illness is approximately $6,038 per site, with average treatment costs ranging from $1,119 to $1,865 per participant over 16 weeks depending on the CM version used.

This study provides a customizable costing tool that helps treatment providers estimate expenses associated with different CM designs, which can aid in budgeting and sustaining CM interventions in their practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budget Impact Tool for Implementing Contingency Management for Co-occurring Alcohol Use Disorders and Serious Mental Illness. Lu, TT., Parent, SC., Chaytor, N., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Improving substance misuse outcomes in contingency management treatment with adjunctive formal psychotherapy: a systematic review and meta-analysis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Contingency management for treatment of substance use disorders: a meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Contingency management treatments decrease psychiatric symptoms. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Contingency management: utility in the treatment of drug abuse disorders. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Budget Impact Tool for Implementing Contingency Management for Co-occurring Alcohol Use Disorders and Serious Mental Illness. [2023]