Mindfulness for Binge Drinking

(Mindfulness Trial)

Overseen By Staci Morris, Psy D

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Disqualifiers: Frequent binge drinking, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an 8-week mindfulness program can reduce binge drinking among Hispanic young adults. Participants will either attend weekly mindfulness sessions or complete assessments without the sessions. The trial includes surveys and basic health checks, such as finger-prick blood samples and heart rate measurements. It suits Hispanic students at FIU who have experienced two or more heavy drinking episodes in the past month but not more than one binge per week. As an unphased trial, this study provides a unique opportunity for participants to contribute to important research while potentially benefiting from mindfulness techniques.

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 seems focused on mindfulness and binge drinking, so it's best to ask the trial organizers for more details.

What prior data suggests that this mindfulness program is safe for Hispanic young adults?

Research has shown that mindfulness-based programs are generally safe for participants. Studies have found these programs to be as effective as other treatments in reducing alcohol and drug use. Regarding safety, mindfulness programs typically do not cause serious side effects. Participants might experience some emotional discomfort when reflecting on personal thoughts and feelings, but this is a normal part of the process. Overall, these programs are well-tolerated and have been successfully used in various settings to assist people with substance use issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mindfulness sessions for binge drinking because this approach is quite different from traditional treatments like counseling, medication, or detox programs. Unlike other methods that primarily focus on abstinence or moderation through behavioral changes or pharmacological interventions, mindfulness sessions aim to address the root cause of binge drinking by enhancing self-awareness and stress reduction. The treatment involves an adapted Mindfulness-Based Stress Reduction (MBSR) program, which helps participants become more aware of their triggers and develop healthier ways to cope with stress. This novel approach not only targets the behavior but also the underlying stress factors, potentially offering a more holistic and sustainable solution.

What evidence suggests that mindfulness sessions might be an effective treatment for binge drinking?

Research has shown that mindfulness-based programs might help reduce alcohol misuse. These programs can be as effective as other treatments in decreasing the frequency and quantity of drinking. They work by lowering stress and improving coping mechanisms, which can lead to less binge drinking. Some studies found small to moderate improvements in maintaining sobriety and reducing stress. While not all studies agree, early results are promising for mindfulness in aiding those who struggle with alcohol use. In this trial, participants will either receive Mindfulness Sessions or be part of an Assessments Only group to evaluate the effectiveness of the mindfulness intervention. ^{3 5 6 7 8}

Who Is on the Research Team?

Michelle Hospital, PhD, LMHC

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

This trial is for Hispanic young adults who engage in binge drinking. Participants must be willing to attend sessions at FIU's MMC campus if assigned to the mindfulness program, and complete online surveys and health measurements over a 14-week period.

Inclusion Criteria

Self-identified Hispanic

Engaged in 2 or more occasions of heavy episodic drinking occasions (HED) (4/5 drinks in one sitting for females/males) during the previous 30 days

Actively enrolled FIU student

Exclusion Criteria

Five or more binge drinking episodes (5+ drinks in one sitting) in the past 30 days, which averages more than once per week

Weekly or more frequent use of other substances, including non-prescribed prescription drugs, illegal drugs, inhalants, or synthetic drugs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week mindfulness program with weekly 1.5-hour sessions

8 weeks

8 visits (in-person)

Post-Intervention Assessment

Participants complete post-intervention assessments and biomarker collections

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biomarker collections

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Sessions

Trial Overview The study tests an 8-week mindfulness-based intervention against a control group with no intervention. The goal is to see if the program can reduce problematic drinking among participants by comparing their behaviors before, during, after the program, and one month later.

How Is the Trial Designed?

Group I: Mindfulness Sessions Experimental Treatment 1 Intervention

An adapted Mindfulness-Based Stress Reduction (MBSR) intervention group (n=60). The intervention is an adapted MBSR 8-week program (1.5 hour/week), and the sessions will be delivered by a facilitator on FIU MMC Campus. Participants will also complete 3 quantitative study assessments and undergo biomarker collections at 4 timepoints .

Group II: Assessments Only Active Control 1 Intervention

Assessment-only control group (n=60). Participants randomly assigned to the control condition will not receive the mindfulness intervention but will complete all study assessments and biomarker collections at the same timepoints as the intervention group (i.e., baseline, post-intervention, 1-month follow-up, and biomarker collections at four timepoints). These participants will not attend any mindfulness group sessions but will be compensated for their participation in data collection activities.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

UConn Health

Collaborator

Trials

218

Recruited

59,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11607543/

Mindfulness as an early intervention for hazardous alcohol ... Mindfulness-Based Interventions (MBI) show promise with regard to alcohol misuse reduction, as well as associated stress reduction. This mini-review discusses ...

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. karger.com karger.com/ear/article/24/3/137/119771/The-Clinical-Efficacy-of-Mindfulness-Based

The Clinical Efficacy of Mindfulness-Based Treatments for ... Small effect sizes were detected in abstinence, levels of perceived stress, and avoidance coping strategies. Moderate effect sizes were revealed ...

5. journals.lww.com journals.lww.com/bsam/fulltext/2021/07000/mindfulness_based_intervention_effects_on.5.aspx

Mindfulness-Based Intervention Effects on Substance Use ... Of the 42 studies, only 3 RCTs evaluated number of days of substance use or binge drinking and provided sufficient data to calculate effect sizes. The ...

6. 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.

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01056484?term=zgierska&rank=1

NCT01056484 | Mindfulness Meditation for Health The RCT evaluated the efficacy of the meditation intervention using self-reported alcohol consumption as primary, and drinking-related harms and subject ...

8. jsatjournal.com jsatjournal.com/article/S0740-5472(18)30419-7/abstract

Mindfulness-based relapse prevention for alcohol ... Outcome analysis included 112 participants (57 MBRP-A; 55 Control) who provided follow-up data. Participants were 41.0 ± 12.2 years old, 56.2% male, and 91% ...