Alcohol Use DisorderPhase 2NCT03256253
Pregabalin as Treatment for Alcohol Use Disorder
A Phase 2 study testing Pregabalin in people with Alcohol Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The proposed protocol is an 8 week open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2018to 31 May 2020
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-5 criteria for current alcohol use disorder
- Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days
- Between the ages of 18 and 65
- Able to provide informed consent and comply with study procedures
Who cannot join
- Subjects with any current psychiatric disorder as defined by DSM-5, other than AUD, that in the investigator's judgment might require intervention over the course of the study.
- Subjects receiving psychotropic medication treatment
- Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar > 13)
- History of alcohol withdrawal seizures or alcohol withdrawal delirium
- History of allergic reaction to candidate medication (pregabalin)
- Pregnancy, lactation, or failure in females patients to use adequate contraceptive methods
Show all 10Show fewer
- Unstable physical disorders which might make participation hazardous
- Subjects who have a current DSM-5 diagnosis of moderate or severe substance use disorder, with the exception of alcohol, nicotine and caffeine use disorders. A diagnosis of a mild substance use disorder will not be exclusionary, as long as the current primary substance use disorder is alcohol.
- Are legally mandated to participate in alcohol use disorder treatment program
- Cognitively impaired
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Pilot Study of Pregabalin as Treatment for Alcohol Use Disorder
The proposed protocol is an 8 week open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.
Read the detailed description
The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.
- Conditions
- Alcohol Use Disorder
- Being tested
- Pregabalin
- Keywords
- alcohol use disorder, alcohol abuse, treatment, lyrica
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called lyrica
pregabalin up to 600 mg/day
| Study group | Role | What they receive |
|---|---|---|
| pregabalin | Experimental | pregabalin up to daily dose of 600 mg Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Dose of Pregabalin:
Defined as the highest amount of medication per day maintained for a 7 day period.
Measured: over the course of the 8 week trial or participants' length of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start15 Feb 2018
- Primary completion31 May 2019
- Study completion31 May 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label pilot study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Mariani MD, New York State Psychiatric Institute
- Investigators
- john mariani, md, Principal investigator, new york psychiatric institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256253
- Sponsor's protocol ID
- 7491
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2017
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mariani JJ, Pavlicova M, Choi CJ, Brooks DJ, Mahony AL, Kosoff Z, Naqvi N, Brezing C, Luo SX, Levin FR. An open-label pilot study of pregabalin pharmacotherapy for alcohol use disorder. Am J Drug Alcohol Abuse. 2021 Jul 4;47(4):467-475. doi: 10.1080/00952990.2021.1901105. Epub 2021 Jun 5.
PubMed 34092158
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study of Pregabalin as Treatment for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03256253
- Acronym / sponsor ID
- 7491
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol use disorder, alcohol abuse, treatment, lyrica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed protocol is an 8 week open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.
Detailed description
The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label pilot study
| Arm | Type | Receives |
|---|---|---|
| pregabalin | Experimental | Drug: Pregabalinpregabalin up to daily dose of 600 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets DSM-5 criteria for current alcohol use disorder
- Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days
- Between the ages of 18 and 65
- Able to provide informed consent and comply with study procedures
Key exclusion criteria (10 listed)
- Subjects with any current psychiatric disorder as defined by DSM-5, other than AUD, that in the investigator's judgment might require intervention over the course of the study.
- Subjects receiving psychotropic medication treatment
- Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar > 13)
- History of alcohol withdrawal seizures or alcohol withdrawal delirium
- History of allergic reaction to candidate medication (pregabalin)
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 |
|---|---|---|
| PregabalinAlso: lyricapregabalin up to 600 mg/day | Drug | pregabalin |
Primary outcome
Maximum Dose of Pregabalin:
Time frame: over the course of the 8 week trial or participants' length of participation
Defined as the highest amount of medication per day maintained for a 7 day period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34092158Mariani JJ, Pavlicova M, Choi CJ, Brooks DJ, Mahony AL, Kosoff Z, Naqvi N, Brezing C, Luo SX, Levin FR. An open-label pilot study of pregabalin pharmacotherapy for alcohol use disorder. Am J Drug Alcohol Abuse. 2021 Jul 4;47(4):467-475. doi: 10.1080/00952990.2021.1901105. Epub 2021 Jun 5.
- 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.
john mariani, md principal investigator
new york psychiatric institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pregabalin in people with Alcohol Use Disorder, run by New York State Psychiatric Institute at 1 site 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 4 inclusion and 10 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Aug 2020). 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?
Maximum Dose of Pregabalin: (time frame: over the course of the 8 week trial or participants' length of participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03256253, which also lists 1 linked publication.
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 31 Aug 2020.