20 Participants NeededMy employer runs this trial

Alcohol Reduction + Probiotics for Alcohol Consumption

TS
Overseen ByTeddy Salan, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of motivational interviewing (a type of counseling) and probiotics can help older adults reduce alcohol consumption and improve brain health. Participants will receive either a probiotic supplement (Visbiome) or a placebo (a non-active pill resembling the supplement) along with motivational interviewing to assess its impact on brain function. The study seeks individuals aged 65 to 84 who drink heavily—defined as more than 14 drinks a week for men and more than 7 for women—and are interested in reducing their alcohol intake. As an unphased trial, it offers a unique opportunity to contribute to understanding innovative approaches for enhancing brain health and reducing alcohol consumption.

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using probiotics, antibiotics, daily steroids, or immunosuppressants.

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

Research has shown that motivational interviewing is generally safe and well-tolerated. It has been proven to help reduce alcohol consumption. For example, one study found that participants reduced their drinking from 90 to 60 drinks per month after six months. Another study observed a decrease in daily drinking by about half a drink per day. These results suggest that motivational interviewing can help people drink less without causing harmful side effects.

Probiotics are usually safe for most people. These beneficial bacteria support gut health and are often found in foods like yogurt. While specific details about the probiotic used in this trial aren't provided, probiotics are generally well-tolerated and commonly used.

Overall, both motivational interviewing and probiotics appear to be safe options based on current research.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique combination of motivational interviewing and probiotics to support alcohol reduction. While traditional treatments for alcohol consumption, such as counseling and medication, often focus solely on behavioral or pharmacological strategies, this approach integrates a probiotic supplement containing 900 billion CFUs to potentially enhance the effects of motivational interviewing. The probiotic is thought to influence gut health, which may play a role in reducing cravings and supporting healthier habits. By combining psychological support with a novel biological approach, this trial is paving the way for a potentially more effective and holistic treatment method for those looking to reduce their alcohol intake.

What evidence suggests that this trial's treatments could be effective for reducing alcohol consumption?

Research has shown that motivational interviewing, which participants in this trial will receive, can help reduce alcohol consumption. Studies have found this method more effective than standard health advice for reducing risky drinking. In this trial, one group will receive motivational interviewing combined with a probiotic supplement, while another group will receive motivational interviewing with a placebo. Evidence suggests that probiotics might aid in treating alcohol addiction by improving gut health. Combining these methods could offer dual benefits: changing drinking habits and enhancing overall health. Although more research is needed, early findings are promising for those looking to reduce alcohol intake.13678

Who Is on the Research Team?

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Teddy Salan, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 65-84 who drink heavily (over 14 drinks/week for men, over 7 for women) and want to cut back on alcohol. Participants must be able to consent, speak English, and not have diabetes, serious mental illness, recent probiotic or antibiotic use, certain medical conditions, or MRI restrictions.

Inclusion Criteria

I am between 65 and 84 years old.
English speaking
I regularly drink more than 14 (men) or 7 (women) alcoholic drinks per week.
See 2 more

Exclusion Criteria

Fasting Glucose > 125 mg/dL
Unable to fast for 12 hours
Past serious alcohol withdrawal symptoms
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a behavioral alcohol-reduction intervention using motivational interviewing and either a probiotic or placebo supplement for 30 days

4 weeks
1 visit (in-person) at baseline, daily self-administration

Follow-up

Participants are monitored for changes in cognitive performance and brain metabolism

4 weeks
1 visit (in-person) at 30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Motivational Interviewing
  • Placebo
  • Visbiome

Trial Overview

The study tests whether motivational interviewing (a counseling method to reduce drinking), combined with either a probiotic supplement (Visbiome) or a placebo, can improve brain function and metabolism in older adults who are high-risk drinkers. Participants are randomly assigned to groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Motivational Interviewing + ProbioticExperimental Treatment2 Interventions
Group II: Motivational Interviewing + PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Exegi Pharma

Collaborator

Trials
1
Recruited
40+

Citations

Effect of Motivational Interviewing on Reduction of Alcohol Use

A culturally-sensitive and easy to implement nurse-led HHP program produced similar reductions in alcohol use over six months.

Research protocol of the efficacy of probiotics for the treatment ...

This study compares the efficacy of probiotic and acceptance and commitment therapy (ACT) in alleviating the severity of alcohol craving and alcohol use ...

Testing the active ingredients of motivational interviewing ...

When taking into account the effect of treatment, for every unit increase in commitment there was a 4% decrease in alcohol use. No treatment was more or less ...

Acceptance and Commitment Therapy and Motivational ...

Acceptance and Commitment Therapy and Motivational Interviewing in the Treatment of Alcohol Use Disorder in a College Woman: A Case Study. October 2018 ...

Motivational interviewing and motivational enhancement ...

Three studies yielded mixed but promising results on the effectiveness of motivational interventions for reducing alcohol use. Dieperink et ...

Motivational Interventions for Reducing Excessive Alcohol ...

MIs significantly reduced daily alcohol intake (−0.55 drinks/day; 95% CI: −0.78 to −0.32), with additional reductions in weekly consumption and ...

Project Motion, A Study of Motivational Interviewing to ...

Motivational interviewing (MI) has been demonstrated to be an effective intervention for alcohol use disorders (AUD). The consistency, magnitude ...

Acceptance and Commitment Therapy and Motivational ...

A group motivational interviewing intervention reduces drinking and alcohol-related consequences in adjudicated college students. Journal of ...