Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT05827159
Eligibility Criteria:
Inclusion Criteria:
1. Between 18 and 80 years in age
2. Diagnosed with moderate to severe Alcohol Use Disorder
3. Stated willingness and ability to comply with all study procedures and availability for the duration of the study
4. Reproductive aged females will have a negative pregnancy test within the past 24 hours and agree to use of highly effective family planning during study participation period
5. Able to speak English sufficiently to understand study procedures and provide written informed consent to participate in the study.
6. Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4.
Exclusion Criteria:
1. A current diagnosis of OUD, self-reported past 7 day opioid or opioid pain medication use, or a positive urine opioid screen (opiates, methadone, buprenorphine, oxycodone, hydrocodone, tramadol and fentanyl)
2. Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery)
3. History of complicated alcohol withdrawal
4. Condition that precludes interview (i.e., life threatening injury/illness)
5. Inability to consent due to cognitive impairment
6. Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation
7. In police custody
8. Unable to provide contact information
9. Previously enrolled in this study or currently enrolled in another study for which they are currently receiving study medications or active ongoing intervention
10. Any contraindication to naltrexone or gabapentin, including known allergy, renal failure, acute hepatitis, hepatic failure,1 or severe lung disease or other chronic conditions such as chronic obstructive pulmonary disease (COPD).
11. Creatine Clearance \<60 mL/min within past 72 hours.
12. Currently pregnant or breast feeding
13. Requiring hospitalization at the time of the index visit
14. Past week treatment with medications for the treatment of alcohol use disorder
15. Taking gabapentin or naltrexone for any reason
16. Appearing unable or unwilling to comply with discharge instructions or complete follow-up
17. Current residence outside of the state of Connecticut
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05827159
Study Brief:
Protocol Section:
NCT05827159