A Phase 4 interventional study of Acamprosate and Placebo in Alcohol Use Disorder, sponsored by Mayo Clinic. Completed at 3 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
AUDs are difficult to treat, and relapse rates are high, with an estimated 80% of individuals with AUDs returning to alcohol use after completing addictions treatment. Novel treatment approaches are needed to enhance long term sobriety. The investigator's research team has been investigating the use of acamprosate to prevent relapse to alcohol use. Unfortunately despite being FDA approved and endorsed by the American Psychiatric Association only 10% of patients treated for AUD are prescribed acamprosate or other antidipsotropic medications. The number is higher for patients treated in programs affiliated with Mayo Clinic Addiction Services (approximately 20%) but is way less than expected. The most common reasons behind these low numbers are the understanding that not every patient benefits from the use of specific medication and the lack of biomarkers predictive of response. The purpose of this project is to identify such biomarkers by discovery of genomic and metabolomic markers associated with response to acamprosate treatment.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 288 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. The most common side effect associated with acamprosate use is diarrhea, which occurs in approximately 16% of patients. Other frequently occurring side effects include asthenia, nausea, pruritus, and flatulence, headache, abdominal pain, flu syndrome, edema, weight gain, and myalgia.
Drug: Acamprosate
All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial.
Other: Placebo
The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
Number of Participants With Continuous Sobriety According to Alcohol Timeline Follow Back
The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
Time frame: Will be defined as continuous sobriety (yes/no) during 3 months of treatment
Day Until First Alcohol Use (Relapse) - Alcohol Timeline Follow Back
The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
Time frame: The number of days until first alcohol use (relapse) assessed by TLFB during 3 months of treatment
Days Until First Relapse (Heavy Relapse) - Timeline Follow Back
The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
Time frame: Number of days until first relapse (heavy relapse) between medication start and 3 months follow-up
Cumulative Abstinence Duration - Timeline Follow Back
The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
Time frame: Cumulative abstinence duration proportion: proportion of days over the length of 3 month follow-up during which participants were abstinent from alcohol use, a score range of 0 (drinking continuously) to 100 (maintain complete abstinence) is applied.
Recruitment for the study began in June of 2019 and continued to July 2023 with follow-up visits completed in October 2023. All participants were recruited while attending a residential intensive treatment program.
| Milestone | Acamprosate | Placebo |
|---|---|---|
| Started | 184 | 104 |
| Completed | 81 | 51 |
| Not completed | 103 | 53 |
The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
| Participants | Acamprosate | Placebo |
|---|---|---|
| Number of Participants With Continuous Sobriety According to Alcohol Timeline Follow Back | 66 | 39 |
The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
| Number of days | Acamprosate | Placebo |
|---|---|---|
| Day Until First Alcohol Use (Relapse) - Alcohol Timeline Follow Back | 80 (31.5 to 89) | 82 (43 to 89) |
The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
| Number of days | Acamprosate | Placebo |
|---|---|---|
| Days Until First Relapse (Heavy Relapse) - Timeline Follow Back | 81 (33 to 89) | 82.5 (52.25 to 89) |
The Alcohol Timeline Follow Back (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.
| percentage of days | Acamprosate | Placebo |
|---|---|---|
| Cumulative Abstinence Duration - Timeline Follow Back | 96.57 ± 6.85 | 96.01 ± 13.90 |
Collected over Adverse event data was collected up to 3 months during each patient's participation.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acamprosate | 0/184 (0%) | 0/184 (0%) | 55/184 (29.9%) |
| Placebo | 0/104 (0%) | 0/104 (0%) | 35/104 (33.7%) |
| Event | Acamprosate | Placebo |
|---|---|---|
| GI virus, upset, Diarrhea, gasGastrointestinal disorders | 10/184 | 4/104 |
| Difficulty SleepingNervous system disorders | 6/184 | 4/104 |
| FatigueNervous system disorders | 1/184 | 4/104 |
| Relapse - alcohol consumptionPsychiatric disorders | 4/184 | 4/104 |
| ER/Hospital visit for suicidal ideation, intoxication, or alcohol withdrawalPsychiatric disorders | 7/184 | 3/104 |
| Muscle pain/feeling achyMusculoskeletal and connective tissue disorders | 7/184 | 2/104 |
| Loss of sexual interest or problems with erection or achieving orgasmReproductive system and breast disorders | 4/184 | 3/104 |
| Cold/FluRespiratory, thoracic and mediastinal disorders | 4/184 | 3/104 |
| Depression, increased depressive thoughts and feelingsPsychiatric disorders | 0/184 | 3/104 |
| Headache/MigraineNervous system disorders | 5/184 | 2/104 |
| Age, Categorical(Participants) | Acamprosate | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 176 | 104 | 280 |
| >=65 years | 8 | 0 | 8 |
| Age, Continuous(Years) | Acamprosate | Placebo | Total |
|---|---|---|---|
| Mean | 45.986 ± 11.761 | 44.023 ± 11.071 | 45.277 ± 11.536 |
| Sex: Female, Male(Participants) | Acamprosate | Placebo | Total |
|---|---|---|---|
| Female | 55 | 30 | 85 |
| Male | 129 | 74 | 203 |
| Ethnicity (NIH/OMB)(Participants) | Acamprosate | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 168 | 96 | 264 |
| Unknown or Not Reported | 16 | 6 | 22 |
| Race (NIH/OMB)(Participants) | Acamprosate | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| Black or African American | 2 | 2 | 4 |
| White | 161 | 95 | 256 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 16 | 6 | 22 |
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