Alcohol Use Disorder
Conditions
Keywords
alcohol use disorder, alcohol abuse, treatment, lyrica
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.
Interventions
DRUGPregabalin
pregabalin up to 600 mg/day
Sponsors
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open label pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Dose of Pregabalin: | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin pregabalin up to daily dose of 600 mg
Pregabalin: pregabalin up to 600 mg/day | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 9 |
| Education | 14.1 years STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 12 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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
Population: Data was available for 14 patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Maximum Dose of Pregabalin: | 571.4 milligrams | Standard Deviation 80.2 |