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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new treatment that combines contingency management (CM) and problem-solving therapy (PST) for young adults with Alcohol Use Disorder (AUD). Participants will be divided into two groups: one receiving only CM, which includes incentives for staying alcohol-free, and the other receiving both CM and PST, which focuses on developing problem-solving skills. The trial will also explore how this treatment affects certain brain areas related to emotions and decision-making. Young adults who drink alcohol at least once a week and meet the criteria for AUD may be eligible to participate. As an unphased trial, this study offers participants the opportunity to contribute to pioneering research that could shape future treatments for AUD.

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.

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

Research has shown that Contingency Management (CM) is generally safe. This method involves giving rewards to encourage behaviors like avoiding alcohol, with no reports of serious side effects.

For the CM-PST (Contingency Management plus Problem Solving Therapy) treatment, early results from small studies suggest it is well-tolerated. Participants attended eight sessions over 12 weeks, learning skills such as problem-solving and stress management. These studies did not report any major negative side effects.

Since this trial is not in its early stages, some information on its safety is available. However, discussing any concerns with the trial organizers or a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Contingency Management with Problem-Solving Therapy (CM-PST) because it combines incentives for abstaining from alcohol with structured problem-solving skills, which is a unique approach compared to traditional treatments like counseling or medications. While standard treatments often focus solely on counseling or medication, CM-PST adds a motivational component through incentives, encouraging participants to stay sober. Additionally, the remote delivery of the therapy via Zoom makes it more accessible for participants, offering flexibility and convenience.

What evidence suggests that this trial's treatments could be effective for Alcohol Use Disorder?

Research has shown that the CM-PST program, available to participants in this trial, can help reduce heavy drinking. This approach combines learning problem-solving skills with receiving rewards for abstaining from alcohol. In a previous study, participants in CM-PST reported significantly less drinking compared to those who received other treatments. The program consists of eight sessions over 12 weeks, focusing on setting goals and managing stress. This method aims to change behavior by teaching useful skills and offering incentives for making positive choices. ^{1 2 3 6 7}

Who Is on the Research Team?

Hagar Hallihan

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12366583/

a single-arm, mixed methods pilot clinical trial - PMC

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pubmed.ncbi.nlm.nih.gov/40829841/

a single-arm, mixed methods pilot clinical trial

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a single-arm, mixed methods pilot clinical trial

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sciencedirect.com/science/article/pii/S0376871624003296

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Studies revealed that integrated intervention led to significant reductions in heavy drinking compared to usual care or other interventions. •.

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researchgate.net/publication/394756925_Feasibility_and_acceptability_of_contingency_management_and_problem-solving_therapy_intervention_for_enhancing_alcohol_abstinence_a_single-arm_mixed_methods_pilot_clinical_trial

a single-arm, mixed methods pilot clinical trial

In acknowledgment of this issue, we developed a novel intervention known as contingency management plus problem solving therapy (CM-PST).

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withpower.com/trial/phase-alcoholism-3-2023-a92e5

Contingency Management Therapies for Alcoholism

Contingency Management (CM) is generally considered safe as it involves providing incentives to encourage positive behaviors, like abstaining from alcohol or ...