CompletedNCT03256253Updated Aug 31, 2020Results posted

Pregabalin as Treatment for Alcohol Use Disorder

A Phase 2 interventional study of Pregabalin in Alcohol Use Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-08-31.

Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 18
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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 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 studied

Alcohol Use Disorder

Browse trials for

Keywords

alcohol use disorder
alcohol abuse
treatment
lyrica

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

Experimental
pregabalin
pregabalin up to daily dose of 600 mg
Drug: Pregabalin

Interventions

DrugPregabalin
pregabalin up to 600 mg/day
Also known as: lyrica

What researchers measure

Primary outcomes

Maximum Dose of Pregabalin:
Defined as the highest amount of medication per day maintained for a 7 day period.
Time frame: over the course of the 8 week trial or participants' length of participation

Results

Posted Aug 13, 2020

Participant flow

Participant flow — Overall Study
Milestone	Pregabalin
Started	18
Completed	6
Not completed	12

Outcome measures

PrimaryMaximum Dose of Pregabalin:

Defined as the highest amount of medication per day maintained for a 7 day period.

Time frame:: over the course of the 8 week trial or participants' length of participation
Reported as:: Mean · milligrams

Maximum Dose of Pregabalin:
milligrams	Pregabalin
Maximum Dose of Pregabalin:	571.4 ± 80.2

Adverse events

Collected over Over the course of the 8 week trial or length of participant's participation. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pregabalin	0/15 (0%)	0/15 (0%)	12/15 (80%)

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Pregabalin
drowsinessGeneral disorders	4/15
fogginessGeneral disorders	3/15
dizzinessGeneral disorders	3/15
insomniaGeneral disorders	3/15
back painMusculoskeletal and connective tissue disorders	2/15
blurred visionEye disorders	2/15
vivid dreamsGeneral disorders	2/15
dry mouthGeneral disorders	2/15
fatigueGeneral disorders	2/15
difficulty concentratingGeneral disorders	1/15

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Pregabalin
Mean	40.1 ± 9.0

Sex: Female, Male
Sex: Female, Male(Participants)	Pregabalin
Female	9
Male	9

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Pregabalin
Hispanic or Latino	9
Not Hispanic or Latino	9
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Pregabalin
American Indian or Alaska Native	0
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	2
White	9
More than one race	1
Unknown or Not Reported	4

Education
Education(years)	Pregabalin
Mean	14.1 ± 2.5

Study locations

1 site

Columbia Univeristy-STARS
New York, New York 10019, United States

References and documents

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 documents

Statistical analysis plan · Jun 28, 2017
Study protocol · Jun 28, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03256253
Lead sponsor: New York State Psychiatric Institute
Responsible party: John Mariani MD (Research psychiatrist, New York State Psychiatric Institute) — Principal investigator
First posted: Aug 21, 2017
Start date: Feb 15, 2018
Primary completion: May 31, 2019
Completion: May 31, 2020
Results posted: Aug 13, 2020
Last update: Aug 31, 2020

Study contacts

john mariani, md

principal investigator · new york psychiatric institute

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Alcoholism→

Other studies from this sponsor

New York State Psychiatric Institute

Start the discussion