Mindfulness-Based Relapse Prevention for Alcohol Consumption

(WAVE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Psychosis, Mania, Severe substance use, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness techniques can help people manage their drinking habits. It examines the relationship between heart rate changes, tracked by a wearable sensor, and self-control and alcohol consumption. Participants answer questions about mood and drinking habits and attend weekly mindfulness sessions for eight weeks. The trial suits individuals with moderate to severe alcohol use issues in the past three months, who can attend group sessions and are comfortable using technology. As an unphased study, this trial offers a unique opportunity to explore innovative mindfulness techniques to improve well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mindfulness-based relapse prevention is safe?

Research has shown that Mindfulness-Based Relapse Prevention (MBRP) is generally easy for participants to handle. Studies on mindfulness treatments for substance use disorders have found no serious negative effects, suggesting that MBRP is safe for managing alcohol use.

Participants in these studies experienced improvements in handling cravings and emotional well-being. This indicates that MBRP may help individuals exercise better self-control and reduce alcohol consumption. Although specific data on adverse reactions is lacking, the absence of negative reports in similar studies is reassuring.

Overall, MBRP appears to be a safe choice with positive outcomes for those interested in using mindfulness to support their recovery from alcohol use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mindfulness-Based Relapse Prevention (MBRP) is unique because it offers a fresh approach to tackling alcohol consumption by focusing on mindfulness techniques. While traditional treatments often involve medication or counseling to manage cravings and prevent relapse, MBRP emphasizes self-awareness and the development of coping strategies through mindfulness practices. This method helps individuals recognize and respond to triggers in healthier ways, potentially reducing relapse rates without relying on pharmaceuticals. Researchers are excited about MBRP because it empowers individuals to take control of their recovery journey, offering a holistic alternative that integrates mental and emotional well-being.

What evidence suggests that mindfulness-based relapse prevention is effective for reducing alcohol consumption?

Research has shown that mindfulness-based relapse prevention (MBRP), the treatment under study in this trial, can help people reduce alcohol consumption. One study found that participants using MBRP had fewer days of substance use compared to those using other treatments. Another study found that MBRP participants were less likely to return to heavy drinking. However, some research suggests that MBRP might not benefit individuals in early recovery when added to their usual care. Overall, MBRP appears promising in helping people manage and reduce their alcohol use. ^{1 5 6 7 8}

Who Is on the Research Team?

Matison W McCool, Phd

Principal Investigator

Center on Alcohol, Substance use, And Addictions - The University of New Mexico

Are You a Good Fit for This Trial?

This trial is for individuals struggling with alcoholism or excessive alcohol consumption. Participants will be required to wear heart rate sensors, attend weekly mindfulness groups for 8 weeks, and answer questions about their mood and drinking habits three times a day during treatment.

Inclusion Criteria

Willing to wear a sensor for the 8-week intervention period and return the sensor after the immediate follow-up

Have a phone/tablet/computer with internet access

Be able to comprehend and consent to study requirements in English

Exclusion Criteria

Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification)

I am experiencing symptoms of psychosis or mania.

I have heart or lung conditions that could affect heart rate data.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week mindfulness-based relapse prevention program, wearing HRV sensors and answering questions about mood and drinking behaviors 3 times a day.

8 weeks

8 group sessions (in-person or virtual)

Follow-up

Participants return sensors and answer questions about mood and drinking behaviors at 3- and 6-months post-treatment.

6 months

2 follow-up assessments (remote)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness based relapse prevention

Trial Overview The study tests if mindfulness-based relapse prevention can improve self-regulation as seen through changes in heart rate variability (HRV) and how these changes may affect drinking behavior, cravings, and negative emotions both during the intervention and up to six months after it ends.

How Is the Trial Designed?

Group I: MBRP Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10488314/

Comparing the Efficacy of Mindfulness-Based Relapse ... Across both treatments, alcohol consumption was reduced, providing continued support for their use in treating AUDs. Findings also indicate that cannabis use ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875923001674

Efficacy of mindfulness-based relapse prevention in a ... At the 12-month follow-up, participants in MBRP, compared to those in RP and TAU, reported significantly fewer days of substance use (31 %) and significantly ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6508889/

Mindfulness-Based Relapse Prevention for Alcohol ... CONCLUSIONS: MBRP-A as an adjunct to usual-care did not show to improve outcomes in alcohol-dependent adults in early recovery compared to usual ...

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/1839290

Relative Efficacy of Mindfulness-Based Relapse ... Compared with TAU, participants assigned to MBRP and RP reported significantly lower risk of relapse to substance use and heavy drinking.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04278352

Mindfulness-Based Relapse Prevention for Opioid and ... A randomized controlled trial will examine mindfulness-based relapse prevention (MBRP) program outcomes for 240 individuals who have completed treatment for ...

6. mindfulrp.com mindfulrp.com/research

Research Below are summaries of sample journal articles assessing the efficacy, effectiveness and mechanisms of mindfulness-based approaches to addictions treatment.

7. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1381489/full

A mindfulness-based intervention for Substance Use ... This study investigates the feasibility of MBRP as an adjunct to outpatient treatment for SUD in a socially vulnerable Brazilian population.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5636047/

Mindfulness-based Relapse Prevention for Substance Use ... We identified 9 randomized controlled trials comprising 901 participants. ... We identified significant differences in favor of MBRP on withdrawal/craving ...