Relapse Prevention for Alcoholism

(ARCH-RPA Trial)

Overseen By Heidi Hutton, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Suicidal, Homicidal, Psychotic, 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: 6

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help individuals with alcohol use disorders avoid relapsing into heavy drinking. It compares three methods: a computer-based program, sessions with a counselor, and usual clinic-based counseling. The goal is to determine which method is most effective and practical for preventing relapse. This trial suits individuals diagnosed with HIV who have a history of alcohol use disorder, have been drinking less recently, and are currently receiving care at the Johns Hopkins HIV Clinic. As an unphased trial, this study provides a unique opportunity to explore innovative methods for managing alcohol use disorders.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that technology-based programs can effectively assist people who drink heavily. These digital tools are user-friendly and can function independently or alongside regular care. Studies indicate they can match the effectiveness of in-person sessions in reducing alcohol use and related issues.

For programs led by individuals, research suggests that mindfulness-based relapse prevention is safe and well-received. It helps reduce alcohol use and impulsive behavior in those seeking help. Participants in these programs often report fewer days of substance use compared to those in standard treatment.

Both types of programs are strongly supported as helpful and safe for people with alcohol use disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these relapse prevention interventions for alcoholism because they offer innovative ways to deliver counseling. Unlike traditional in-person counseling, the computer-delivered intervention provides a flexible and accessible option, allowing individuals to receive guidance at their convenience. The person-delivered intervention, on the other hand, offers a personalized touch with direct interaction from a counselor, which can enhance motivation and support. Both methods aim to prevent relapse into hazardous drinking by offering concise, two-session formats, potentially making them more appealing and manageable for individuals compared to longer, ongoing treatments.

What evidence suggests that this trial's treatments could be effective for preventing relapse in alcohol use disorders?

Research has shown that online cognitive-behavioral therapy (CBT) can help reduce heavy drinking. In this trial, participants may receive a computer-delivered Relapse Prevention Intervention (RPI), a digital treatment effective on its own or when combined with regular care for alcohol problems. Alternatively, participants may receive a person-delivered RPI, where mindfulness-based relapse prevention (MBRP) has been found to lower the chance of returning to heavy drinking compared to standard treatment. Specifically, individuals who participated in MBRP had fewer heavy drinking days over a year than those who only engaged in CBT. Both methods in this trial aim to help individuals stay sober and avoid relapse. ^{1 2 5 6 7}

Who Is on the Research Team?

Heidi Hutton, PhD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HIV who are patients at Johns Hopkins HIV Clinic. They must have a history of alcohol use disorder, varying drinking patterns, and currently be abstinent or drinking minimally. Non-English speakers, those acutely suicidal or unable to consent are excluded.

Inclusion Criteria

Meet the following alcohol use criteria: lifetime alcohol use disorder, patient reported outcomes (PRO) assessment collected by the Center for AIDS Research (CFAR) Network of Clinical Systems as part of usual clinical care that show in the last 3 years: periods of no or lower risk drinking (e.g. women/men who are drinking <11/22 drinks per week) and periods of lapse to higher levels of drinking (=>11/22 drinks per week for women/men), current PRO showing alcohol abstinence or alcohol use at <11/22 drinks per week for women/men.

I have been diagnosed with HIV.

Must be enrolled in clinical care at Johns Hopkins HIV Clinic

Exclusion Criteria

Acutely suicidal, homicidal, psychotic or otherwise unable to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 2-session relapse prevention intervention, either computer or person delivered, or treatment as usual

2 sessions

Follow-up

Participants are monitored for changes in alcohol use patterns and time to relapse

12 months

Assessments at baseline, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Relapse Prevention Intervention

Trial Overview

The study tests an adapted relapse prevention intervention for alcohol use disorders in people with HIV. It's a pilot trial comparing three groups: one gets computerized sessions, another person-delivered sessions, and the third group might receive usual care.

How Is the Trial Designed?

Group I: Person delivered RPI Experimental Treatment 1 Intervention

2 session counselor delivered counseling to prevent relapse to hazardous drinking

Group II: Computer delivered RPI Experimental Treatment 1 Intervention

2 session computer delivered counseling to prevent relapse to hazardous drinking

Group III: Treatment as Usual Active Control 1 Intervention

Counseling for alcohol use available in clinic as treatment as usual

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

In a study of 609 self-referred addicts in Bushehr province, 73.1% reported substance use in the past year, with 72% experiencing a full relapse, highlighting the significant challenge of relapse prevention.

The primary triggers for relapse were identified as unpleasant emotions and physical discomfort, suggesting that addressing these emotional and physical factors is crucial in developing effective treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High risk situations predicting relapse in self-referred addicts to bushehr province substance abuse treatment centers. Shafiei, E., Hoseini, AF., Bibak, A., et al.[2021]

Mindfulness-based relapse prevention (MBRP) and cognitive-behavioral relapse prevention (RP) significantly reduced the risk of relapse to substance use and heavy drinking compared to treatment as usual (TAU) during a 12-month follow-up with 286 participants.

At the 12-month mark, MBRP participants reported fewer days of substance use and heavy drinking compared to both RP and TAU, suggesting that mindfulness practices can enhance long-term recovery outcomes by helping individuals manage cravings and negative emotions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. Bowen, S., Witkiewitz, K., Clifasefi, SL., et al.[2022]

Relapse prevention (RP) is generally effective in treating substance use disorders, especially for alcohol problems, based on a meta-analysis of 26 studies involving 9,504 participants.

The effectiveness of RP is enhanced when used for alcohol or polysubstance use disorders, combined with medication, and assessed immediately after treatment using pre-post tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of relapse prevention: a meta-analytic review. Irvin, JE., Bowers, CA., Dunn, ME., et al.[2019]

The Relapse Prevention (RP) model has evolved significantly over the last decade, incorporating a reformulated cognitive-behavioral approach and mindfulness-based strategies to better address addictive behaviors.

Despite its integration into various treatment modalities, the RP model's systematic evaluation has been hindered, yet it continues to be a key framework for understanding and facilitating behavior change in addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relapse prevention for addictive behaviors. Hendershot, CS., Witkiewitz, K., George, WH., et al.[2023]

The study involved 168 adults with substance use disorders and evaluated an 8-week Mindfulness-Based Relapse Prevention (MBRP) program, showing it was feasible with high participant satisfaction and good homework compliance.

Participants in the MBRP program had significantly lower rates of substance use and greater improvements in craving management and mindfulness skills compared to those receiving standard treatment as usual (TAU) over a 4-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Bowen, S., Chawla, N., Collins, SE., et al.[2022]

Mindfulness-based relapse prevention (MBRP) was more effective than traditional relapse prevention (RP) in maintaining reductions in heavy drinking days (HDD) after treatment, with MBRP participants showing significantly less HDD at follow-up.

Cannabis use frequency influenced treatment outcomes, where higher cannabis use was linked to continued decreases in HDD and drinks per drinking day (DDD) for MBRP participants, while RP participants experienced increased HDD with high cannabis use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Efficacy of Mindfulness-Based Relapse Prevention Versus Relapse Prevention for Alcohol Use Disorder: A Randomized Control Trial. Skrzynski, CJ., Karoly, H., Ellingson, JM., et al.[2023]

Mindfulness-Based Relapse Prevention (MBRP) is a leading program in addiction treatment that enhances awareness of triggers and automatic behaviors associated with drug abuse.

Research indicates that mindfulness practices can effectively reduce cravings and improve predictions of relapse, showing promising results in supporting individuals recovering from addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness in addiction therapy]. Nallet, A., Briefer, JF., Perret, I.[2015]

A study involving 64 German alcoholics undergoing a 4-step cognitive-behavioral relapse prevention program showed that high self-efficacy and confidence in managing high-risk situations are crucial for preventing relapse.

Despite no significant change in craving levels before and after treatment, the program effectively enhanced participants' coping skills and optimism, suggesting its applicability in both inpatient and outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Relapse prevention group for alcohol dependent patients]. Johann, M., Bobbe, G., Franke, E., et al.[2018]

A study involving 64 German alcoholics undergoing a 4-step cognitive-behavioral relapse prevention program showed that high self-efficacy and confidence in managing high-risk situations are crucial for preventing relapse.

Despite no significant change in craving levels before and after treatment, the program effectively enhanced participants' coping skills and optimism, suggesting its applicability in both inpatient and outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Relapse Prevention Program in German Alcoholics] Johann, M., Bobbe, G., Franke, E., et al.[2019]

A new scoring algorithm categorizes alcohol relapse triggers into three types: negative affect, social pressure, and craving/cued relapses, based on a prospective study using the Reasons for Drinking Questionnaire.

Findings indicate that social pressure relapses tend to recur more frequently, while negative affect and craving relapses are more severe; notably, craving relapses decrease in the first 6 months post-treatment but can re-emerge if a relapse occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory findings from the Reasons for Drinking Questionnaire. Zywiak, WH., Westerberg, VS., Connors, GJ., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6824956/

Technology-Delivered Cognitive-Behavioral Interventions ...

These results show a benefit for technology-delivered, CBT-based interventions as a stand-alone therapy for heavy drinking or as an addition to usual care.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5714654/

Cognitive Behavioral Interventions for Alcohol and Drug ...

Cognitive behavioral therapy (CBT) approaches have among the highest level of empirical support for the treatment of drug and alcohol use disorders.

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sciencedirect.com

sciencedirect.com/science/article/pii/S2772598724000291

Digital interventions for alcohol use disorders: A narrative ...

This narrative review aimed to summarize recent evidence on the use of digital interventions for AUD, and to critically assess the promise and pitfalls of ...

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psycnet.apa.org

psycnet.apa.org/record/2020-72922-035

Computer-based cognitive behavioral therapies.

Use of digital technology to provide or enhance the delivery of psychotherapeutic interventions for addictions: Computer-based cognitive behavioral therapies.

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researchprotocols.org

researchprotocols.org/2023/1/e44694/

Developing and Implementing a Web-Based Relapse ...

Patients with AUD frequently experience high relapse rates, and only 1 in 5 remain abstinent 12 months post treatment. Traditional face-to-face ...

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frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1486338/full

The effects of cognitive behavioral therapy-based digital ...

These findings suggest that digital CBT-based interventions can be an effective alternative to face-to-face CBT for reducing alcohol use and related symptoms.

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health.harvard.edu

health.harvard.edu/blog/small-study-suggests-benefits-of-computer-based-cbt-for-substance-abuse-2018082014434

Small study suggests benefits of computer-guided CBT for ...

Specifically, CBT4CBT covers: how to understand and change patterns of substance use; dealing with cravings; refusing offers of alcohol and ...