Alcohol Use DisorderPhase 4NCT03818191
Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome
A Phase 4 study testing Acamprosate in people with Alcohol Use Disorder, run by Mayo Clinic at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Acamprosate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jul 2019to 4 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to85; DSM-5 diagnosis of AUD determined by PRISM;
- Completion of alcohol detoxification (CIWA score < 5) and no alcohol for at least 7 days (but no more than 35 days);
- Ability to provide informed consent
- Ability to speak English
- Willingness to use the study medications for 3 months and attend follow-up visits.
- 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).
- Willingness to discontinue previously prescribed acamprosate for a period of at least 3 days before randomization to study medication (acamprosate or placebo).
Who cannot join
- Hypersensitivity or allergy to acamprosate
- Current use of wellbutrin and not willing to switch to an acceptable antidepressant medication
- Renal impairment (creatinine level >1.5 mg/dL);
- Diagnosis of advanced liver disease indicated in the medical record or by a MELD score of above 10;
- Women who are pregnant, breastfeeding, or planning to become pregnant during the next year;
- 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
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- 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.
- Current use of Naltrexone and not willing to stop and switch to Acamprosate/Placebo
- Current use of Antabuse.
- Active suicidal ideation or any unstable medical or psychiatric condition as determined by responses to PRISM or by the investigator.
- Status of involuntary or court-ordered admission at time of consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hazelden Betty Ford Foundation
Center City, Minnesota, 55012
Hazelden Betty Ford Foundation
Newberg, Oregon, 97132
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Acamprosate, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamprosateDrug
The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
PlaceboOther
The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
| Study group | Role | What they receive |
|---|---|---|
| Acamprosate | Active comparator | 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. Receives: Drug: Acamprosate |
| Placebo | Placebo comparator | All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Will be defined as continuous sobriety (yes/no) during 3 months of treatment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start15 Jul 2019
- Primary completion4 Nov 2023
- Study completion4 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Victor M. Karpyak, Mayo Clinic
- Investigators
- Victor M Karpyak, MD, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818191
- Sponsor's protocol ID
- 18-006428
- Other IDs
- 1R01AA027486-01, 1U01AA027487
- Status last verified
- Nov 2024
- First submitted
- 14 Jan 2019
- Last updated
- 17 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome
- ClinicalTrials.gov ID
- NCT03818191
- Acronym / sponsor ID
- 18-006428
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 4 Nov 2023 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 17 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acamprosate | Active comparator | Drug: AcamprosateAll 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. |
| Placebo | Placebo comparator | Other: PlaceboAll participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to85; DSM-5 diagnosis of AUD determined by PRISM;
- Completion of alcohol detoxification (CIWA score < 5) and no alcohol for at least 7 days (but no more than 35 days);
- Ability to provide informed consent
- Ability to speak English
- Willingness to use the study medications for 3 months and attend follow-up visits.
Key exclusion criteria (11 listed)
- Hypersensitivity or allergy to acamprosate
- Current use of wellbutrin and not willing to switch to an acceptable antidepressant medication
- Renal impairment (creatinine level >1.5 mg/dL);
- Diagnosis of advanced liver disease indicated in the medical record or by a MELD score of above 10;
- Women who are pregnant, breastfeeding, or planning to become pregnant during the next year;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcamprosateThe research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. | Drug | Acamprosate |
| PlaceboThe research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate. | Other | Placebo |
Primary outcome
Number of Participants With Continuous Sobriety According to Alcohol Timeline Follow Back
Time frame: Will be defined as continuous sobriety (yes/no) during 3 months of treatment
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.
3 secondary outcomes
Day Until First Alcohol Use (Relapse) - Alcohol Timeline Follow Back
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
Time frame: Number of days until first relapse (heavy relapse) between medication start and 3 months follow-up
Cumulative Abstinence Duration - Timeline Follow Back
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor M Karpyak, MD, Ph.D. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acamprosate in people with Alcohol Use Disorder, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Continuous Sobriety According to Alcohol Timeline Follow Back (time frame: Will be defined as continuous sobriety (yes/no) during 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.