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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT03244592
Eligibility Criteria:
Inclusion Criteria:
1. Ages 25 - 45
2. Meet DSM-5 diagnostic criteria for an AUD \[n.b., only participants with moderate or severe AUD will be enrolled\]
3. Drink ≥ 48 standard drinks in a 30-day period before enrollment
Exclusion Criteria:
1. Currently in treatment for AUD, a history of treatment in the 30 days before enrollment, or currently treatment seeking
2. Current (last 12 months) DSM-V diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
3. Lifetime DSM-V diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
4. Positive urine screen for narcotics, amphetamines, or sedative hypnotics
5. Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised
6. Pregnancy, nursing, or refusal to use reliable method of birth control (if female)
7. A medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
8. AST, ALT, or GGT ≥ 3 times upper normal limit
9. Attempted suicide in the past 3 years and/or serious suicidal intention or plan within the past year
10. Currently on prescription medication that contraindicates use of MINO
11. Any other circumstances that, in the opinion of the investigators, compromises participant safety.
12. Claustrophobia
13. Participating in any other research study involving exposure to ionizing radiation in the past year will be excluded if the total cumulative exposure from the past research studies and the current research study would exceed the limits set by the FDA in 21 CFR 361.1. Specifically, the total cumulated dose to the whole body, active blood-forming organs, lens of the eye, and gonads must remain below 5 rems, and the cumulated dose to all other organs must remain below 15 rems. Potential participants who have had exposure to ionizing radiation in the past year will not be allowed to participate if we are unable to obtain proper documentation quantifying the amount of past exposure.
14. Presence of a metal device in the body (e.g., pacemaker, infusion pump, aneurysm clip, metal prosthesis or plate): Those devices could either interfere with the acquisition of the MRI scan of the brain or for whom the MRI scan would pose a potential risk. If participants have a non-removable device in their body, they must acquire and show a document exhibiting the device is MRI-compatible.
15. low affinity rs6971 genotype
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT03244592
Study Brief:
Protocol Section:
NCT03244592