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

Trial Summary

What is the purpose of this trial?

3-arm type 1 pilot implementation-efficacy trial for people with alcohol use disorders to examine the preliminary effectiveness and feasibility of an adapted 2-session, computerized and person delivered relapse prevention intervention.

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.

What data supports the effectiveness of the treatment Relapse Prevention Intervention for alcoholism?

Research shows that relapse prevention, especially when combined with cognitive-behavioral approaches, is generally effective for alcohol problems. Mindfulness-Based Relapse Prevention (MBRP) has also shown promise, with participants experiencing lower rates of substance use and reduced cravings compared to standard treatments. ^{1 2 3 4 5}

Is relapse prevention therapy safe for humans?

Relapse prevention therapies, including mindfulness-based and cognitive-behavioral approaches, are generally considered safe for humans, as they focus on teaching skills to manage triggers and cravings without involving medication. ^{3 5 6 7 8}

How is Relapse Prevention Intervention different from other treatments for alcoholism?

Relapse Prevention Intervention is unique because it combines cognitive-behavioral strategies with mindfulness techniques to help individuals recognize and cope with triggers that may lead to relapse, focusing on both mental and emotional aspects of addiction. ^{3 6 7 9 10}

Research Team

Heidi Hutton, PhD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

I speak English.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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) 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]

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]

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) 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Relapse prevention group for alcohol dependent patients]. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[Relapse Prevention Program in German Alcoholics] [2019]

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

Efficacy of relapse prevention: a meta-analytic review. [2019]

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

Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. [2022]

5. United States 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. [2022]

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

Comparing the Efficacy of Mindfulness-Based Relapse Prevention Versus Relapse Prevention for Alcohol Use Disorder: A Randomized Control Trial. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

High risk situations predicting relapse in self-referred addicts to bushehr province substance abuse treatment centers. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Mindfulness in addiction therapy]. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Relapse prevention for addictive behaviors. [2023]

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

Exploratory findings from the Reasons for Drinking Questionnaire. [2022]