Clinical trial NCT03256253: Pregabalin as Treatment for Alcohol Use Disorder
Official title: An Open-Label Pilot Study of Pregabalin as Treatment for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: alcohol use disorder
alcohol abuse
treatment
lyrica
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label pilot study
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Maximum Dose of Pregabalin:
timeFrame: over the course of the 8 week trial or participants' length of participation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Univeristy-STARS
state: New York
Study officials:
affiliation: new york psychiatric institute
name: john mariani, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.