Clinical Trials Logo

Clinical Trial Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.


Clinical Trial Description

These intestinal microbiota transplant (IMT) capsules are an investigational drug, which means it has not been approved by the U. S. Food and Drug Administration (FDA). In this study, drug name will be compared to placebo (a look-alike inactive substance, a "sugar pill"). Participants will be randomly assigned (like the flip of a coin) to receive either IMT capsules or placebo capsules. Participants have an equal chance of being assigned to any one of the groups. In this study, participants will be asked to do the following things: 1. Visit VCU medical center up to 8 times for study visits 2. Take either IMT capsule or the placebo, depending upon which group they are assigned to; these capsules will be given twice on enrollment and after one month 3. Have blood drawn, urine and stool collected at each visit 4. Have testing done to determine the speed of brain function 5. Keep a diary at home 6. Take surveys and answer questions about general health, alcohol craving and consumption and how they are feeling. 7. Give permission for the researchers to collect information about liver disease, alcohol and mental health from medical records. Participation in this study will last up to 7 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05548452
Study type Interventional
Source Virginia Commonwealth University
Contact Jasmohan S Bajaj, MD
Phone 804 675 5802
Email jasmohan.bajaj@vcuhealth.org
Status Recruiting
Phase Phase 1/Phase 2
Start date November 21, 2022
Completion date December 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04788004 - Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
Recruiting NCT05684094 - Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function N/A
Completed NCT03406039 - Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems N/A
Completed NCT03573167 - Mobile Phone-Based Motivational Interviewing in Kenya N/A
Completed NCT04817410 - ED Initiated Oral Naltrexone for AUD Phase 1
Active, not recruiting NCT04267692 - Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders N/A
Completed NCT03872128 - The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders Phase 1
Completed NCT02989662 - INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers Phase 1/Phase 2
Recruiting NCT06030154 - Amplification of Positivity for Alcohol Use N/A
Active, not recruiting NCT05419128 - Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19 N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT04203966 - Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
Recruiting NCT05861843 - Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Enrolling by invitation NCT04128761 - Decreasing the Temporal Window in Individuals With Alcohol Use Disorder N/A
Not yet recruiting NCT06337721 - Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults N/A
Not yet recruiting NCT06444243 - Psilocybin-assisted Therapy for Alcohol Use Disorder Phase 2
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Enrolling by invitation NCT02544581 - Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare N/A