Phase
Condition
Alcohol Use Disorder
Addictions
Alcohol Dependence
Treatment
Brief Negotiation Interview
Naltrexone Pill
Gabapentin Pill
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Between 18 and 80 years in age
Diagnosed with moderate to severe Alcohol Use Disorder
Stated willingness and ability to comply with all study procedures and availabilityfor the duration of the study
Reproductive aged females will have a negative pregnancy test within the past 24hours and agree to use of highly effective family planning during studyparticipation period
Able to speak English sufficiently to understand study procedures and providewritten informed consent to participate in the study.
Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4.
Exclusion
Exclusion Criteria:
A current diagnosis of OUD, self-reported past 7 day opioid or opioid painmedication use, or a positive urine opioid screen (opiates, methadone,buprenorphine, oxycodone, hydrocodone, tramadol and fentanyl)
Current prescription of opioid pain medications, or anticipated need for opioid painmedications during the study period (i.e. planned surgery)
History of complicated alcohol withdrawal
Condition that precludes interview (i.e., life threatening injury/illness)
Inability to consent due to cognitive impairment
Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation
In police custody
Unable to provide contact information
Previously enrolled in this study or currently enrolled in another study for whichthey are currently receiving study medications or active ongoing intervention
Any contraindication to naltrexone or gabapentin, including known allergy, renalfailure, acute hepatitis, hepatic failure,1 or severe lung disease or other chronicconditions such as chronic obstructive pulmonary disease (COPD).
Creatine Clearance <60 mL/min within past 72 hours.
Currently pregnant or breast feeding
Requiring hospitalization at the time of the index visit
Past week treatment with medications for the treatment of alcohol use disorder
Taking gabapentin or naltrexone for any reason
Appearing unable or unwilling to comply with discharge instructions or completefollow-up
Current residence outside of the state of Connecticut
Study Design
Study Description
Connect with a study center
Yale New Haven Hospital
New Haven, Connecticut 06520
United StatesActive - Recruiting
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