Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome
NCT ID: NCT03818191
Last Updated: 2024-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
288 participants
INTERVENTIONAL
2019-07-15
2023-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Acamprosate
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.
Acamprosate
The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
Placebo
All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial.
Placebo
The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
Interventions
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Acamprosate
The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
Placebo
The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
Eligibility Criteria
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Inclusion Criteria
2. Completion of alcohol detoxification (CIWA score \< 5) and no alcohol for at least 7 days (but no more than 35 days);
3. Ability to provide informed consent
4. Ability to speak English
5. Willingness to use the study medications for 3 months and attend follow-up visits.
6. No chronic/daily use of benzodiazepines, opioids, or stimulants for a period of time which is determined by 3 x the medication half-life value (see addendum A) to be completed before the initiation of study medication (acamprosate or placebo).
7. Willingness to discontinue previously prescribed acamprosate for a period of at least 3 days before randomization to study medication (acamprosate or placebo).
Exclusion Criteria
2. Current use of wellbutrin and not willing to switch to an acceptable antidepressant medication
3. Renal impairment (creatinine level \>1.5 mg/dL);
4. Diagnosis of advanced liver disease indicated in the medical record or by a MELD score of above 10;
5. Women who are pregnant, breastfeeding, or planning to become pregnant during the next year;
6. Primary diagnosis of substance use disorder other than alcohol as determined by PRISM or in medical record review or secondary diagnosis of active (within the past year) benzo/sedative dependence, opioid dependence, stimulant dependence, heroin dependence, and/or cocaine dependence
7. Refusal to abstain from any chronic/daily use of prescribed benzodiazepines, opioids, stimulants, cannabis related medication such as CBD or medical marijuana, during the course of participation.
8. Current use of Naltrexone and not willing to stop and switch to Acamprosate/Placebo
9. Current use of Antabuse.
10. Active suicidal ideation or any unstable medical or psychiatric condition as determined by responses to PRISM or by the investigator.
11. Status of involuntary or court-ordered admission at time of consent.
18 Years
85 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Mayo Clinic
OTHER
Responsible Party
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Victor M. Karpyak
Principal Investigator
Principal Investigators
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Victor M Karpyak, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Hazelden Betty Ford Foundation
Center City, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Hazelden Betty Ford Foundation
Newberg, Oregon, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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