Mindfulness for Alcoholism

(MIT Trial)

Overseen By Jenna Shold, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The Mind Research Network

Disqualifiers: Psychotic disorder, Dementia, CNS disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness can help female prison inmates reduce alcohol abuse and avoid returning to prison. Researchers are comparing mindfulness techniques with other methods, such as relapse prevention (a therapy focused on preventing a return to alcohol use) and standard treatments, to identify the most effective way to break the cycle of alcohol abuse and criminal behavior. Women diagnosed with Alcohol Use Disorder who are soon to be released from prison are eligible to participate. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new, effective treatments for alcohol abuse.

Will I have to stop taking my current medications?

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 mindfulness-based treatments are generally safe for people with substance use problems. These treatments are as effective as other proven methods in reducing alcohol and drug use. They also alleviate depression, anxiety, and stress, which often accompany addiction.

For preventing relapse, studies suggest that adding mindfulness to regular care might not significantly impact those recovering from alcohol dependence. However, this treatment does not cause harm or major side effects.

Overall, both mindfulness and relapse prevention methods are well-tolerated and do not cause major issues for most participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mindfulness for alcoholism because it offers a unique, non-pharmacological approach to treatment. Unlike traditional options like medications (e.g., naltrexone or acamprosate) and behavioral therapies (e.g., cognitive-behavioral therapy), mindfulness focuses on enhancing self-awareness and emotional regulation, potentially reducing reliance on alcohol without side effects. This technique trains individuals to recognize and manage cravings, which could lead to more sustainable long-term recovery. Additionally, the relapse prevention arm aims to develop strategies to maintain sobriety, addressing a significant challenge in treating alcoholism. This holistic approach provides a promising alternative or complement to existing treatments.

What evidence suggests that this trial's treatments could be effective for alcoholism?

Studies have shown that mindfulness-based programs can be as effective as other treatments for substance use problems, including reducing alcohol use. However, results are mixed, and some studies found no improvements when mindfulness was added to regular care for alcohol dependence. In this trial, participants will be assigned to different treatment arms, including a Mindfulness arm and a Relapse Prevention arm. Research on mindfulness-based relapse prevention suggests it might help reduce the risk of returning to substance use. Participants in these programs reported fewer and less severe relapses compared to those receiving standard care. Overall, while mindfulness appears promising, its effectiveness can vary depending on its application and the specific group involved. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking female inmates aged 18-65 with alcohol use disorder, who are not due to be released within the next three months. They must have at least a 5th-grade reading level. Those with metal in their body, low IQ scores, psychotic disorders, dementia or cognitive disabilities, major illnesses or CNS diseases, and severe hearing or vision problems cannot join.

Inclusion Criteria

I am biologically female.

Time to release from incarceration > 3 months

You should be able to read and understand texts at least at a 5th grade level.

Exclusion Criteria

You have a history of dementia or other conditions that affect your ability to think and remember.

Your IQ score is below 70.

You cannot have an MRI scan because you have metal in your body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to a mindfulness or relapse prevention training course, compared against a no treatment control

8 weeks

In-person sessions during incarceration

Follow-up

Participants are monitored for changes in alcohol consumption, craving, and criminal behavior after release

6 months

Every 3 months after release

Post-release Monitoring

Collection of outcome measures including alcohol use relapse and antisocial behavior

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness
• Relapse Prevention

Trial Overview

The study is evaluating a mindfulness program designed to address neuropsychological factors linked to relapse and criminal behavior in women prisoners with alcohol abuse issues. The goal is to reduce the cycle of drinking and re-offending.

How Is the Trial Designed?

Group I: Relapse Prevention Experimental Treatment 1 Intervention

Group II: Mindfulness Experimental Treatment 1 Intervention

Mindfulness

Group III: Treatment as Usual Active Control 1 Intervention

Group IV: Waitlist Control Active Control 1 Intervention

Mindfulness is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mindfulness-Based Interventions for:

• Substance Abuse Treatment
• Anxiety Disorders
• Depression

Approved in European Union as Mindfulness-Based Stress Reduction for:

• Stress Management
• Anxiety Disorders
• Chronic Pain

Approved in Canada as Mindfulness-Based Cognitive Therapy for:

• Depression
• Anxiety Disorders
• Substance Abuse Treatment

Who Is Running the Clinical Trial?

The Mind Research Network

Lead Sponsor

Trials

27

Recruited

2,300+

University of Wisconsin, Madison

Collaborator

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

The mindfulness-based relapse prevention for alcohol dependence (MBRP-A) did not show significant improvements in drinking outcomes compared to usual care alone in a study of 123 alcohol-dependent adults over 26 weeks.

However, participants who attended more MBRP-A sessions and practiced mindfulness techniques at home tended to have better long-term drinking-related outcomes, suggesting that adherence to the intervention may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial. Zgierska, AE., Burzinski, CA., Mundt, MP., et al.[2020]

Mindfulness-based treatments, particularly Mindfulness-Based Relapse Prevention (MBRP), are increasingly recognized as effective methods for treating addiction, including substance use and behavioral addictions like gambling.

The paper reviews various theoretical models and mechanisms of how mindfulness can facilitate recovery, while also highlighting the need for further research to refine treatment protocols and understand factors that influence their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based treatment to prevent addictive behavior relapse: theoretical models and hypothesized mechanisms of change. Witkiewitz, K., Bowen, S., Harrop, EN., et al.[2023]

Mindfulness-based therapies have shown promising results in reducing substance use in individuals with addictive disorders, with five out of six studies indicating significant reductions in substance use, particularly when follow-up periods were longer.

These interventions not only decreased substance use but also helped participants manage withdrawal-like sensations and emotional responses, suggesting that mindfulness can enhance coping strategies and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness based interventions for addictive disorders: a review]. Skanavi, S., Laqueille, X., Aubin, HJ.[2018]

Mindfulness-Based Stress Reduction (MBSR) has been shown to improve mental health in 11 studies compared to waitlist controls or treatment as usual, demonstrating its efficacy as a therapeutic intervention.

Mindfulness-Based Cognitive Therapy (MBCT) effectively reduces the risk of depressive relapse, showing similar efficacy to treatment as usual in two studies, indicating its potential as a preventive measure for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Fjorback, LO., Arendt, M., Ornbøl, E., et al.[2022]

Mindfulness-based interventions (MBIs) have been found to be as effective as traditional treatments for substance use disorders, helping to reduce the frequency and quantity of substance use, cravings, and related problems based on a systematic review of 30 randomized controlled trials.

The review highlights the need for further large-scale studies to explore the best settings and protocols for MBIs, as well as to identify which patient populations may benefit the most from these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based programs for substance use disorders: a systematic review of manualized treatments. Korecki, JR., Schwebel, FJ., Votaw, VR., et al.[2021]

Participants recovering from alcohol and opioid use disorders found mindfulness-based interventions (MBIs) beneficial for their recovery, particularly valuing the non-pharmacological nature of these therapies.

Key factors influencing participation in MBIs included perceived provider empathy and social connectedness, with participants suggesting that incentives like gift cards could enhance engagement and retention in recovery programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions about mindfulness-based interventions among individuals recovering from opioid and alcohol use disorders: Findings from focus groups. Jones, KO., Lopes, S., Chen, L., et al.[2020]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

Mindfulness training significantly reduced stress and thought suppression in alcohol-dependent adults, suggesting it can help manage triggers for relapse.

Participants who underwent mindfulness training showed improved physiological recovery from alcohol cues and reduced attentional bias towards alcohol, indicating its potential as an effective treatment for preventing relapse in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training modifies cognitive, affective, and physiological mechanisms implicated in alcohol dependence: results of a randomized controlled pilot trial. Garland, EL., Gaylord, SA., Boettiger, CA., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8527365/

Mindfulness‐based interventions for substance use disorders

Mindfulness‐based interventions (MBIs) have been examined for the treatment of SUDs, but available evidence is mixed.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0740547218304197

Mindfulness-based relapse prevention for alcohol ...

MBRP-A as an adjunct to usual-care did not show to improve outcomes in alcohol-dependent adults in early recovery compared to usual-care-alone.

3.

substanceabusepolicy.biomedcentral.com

substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-020-00293-3

Mindfulness-based programs for substance use disorders

MBIs appear to be as effective as existing evidence-based treatments for substance use disorders at reducing the frequency and quantity of alcohol and drug use.

4.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2018.00095/full

Mindfulness-Based Interventions for the Treatment of ...

Results: Mindfulness-based interventions were applied in a wide range of addictions, including substance use disorders (from smoking to alcohol, among others) ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06757842

Acceptability and Feasibility of an In-person 8-week ...

Programs like "Mindfulness-Based Stress Reduction" (MBSR) have proven effective in reducing symptoms of depression, anxiety, and stress. Studies indicate that ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8083197/

Mindfulness-based interventions: an overall review - PMC

MBIs are effective for improving many biopsychosocial conditions, including depression, anxiety, stress, insomnia, addiction, psychosis, pain, hypertension, ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352853222000621

Mindfulness-based interventions in inpatient treatment for ...

This review provides an overview of studies of MBIs performed in inpatient treatment for substance use disorder. •. The effects for experimental groups were ...

8.

cochranelibrary.com

cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011723.pub2/references

Mindfulness‐based interventions for substance use disorders

Effect of mindfulness based relapse prevention on developmental trends, stress, and substance use among young adults in residential substance use treatment: a ...