Status:
WITHDRAWN
Minocycline for Alcohol Use Disorder
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Inflammation
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of this proposal is to advance medication development for alcohol use disorder by examining the efficacy and mechanisms of action of minocycline, a neuroimmune modulator, as a potential ...
Detailed Description
The research objective of this project is to advance medication development for AUD by conducting a randomized, double blind, placebo-controlled, neuroimaging study to examine the effects of minocycli...
Eligibility Criteria
Inclusion
- Ages 25 - 45
- Meet DSM-5 diagnostic criteria for an AUD \[n.b., only participants with moderate or severe AUD will be enrolled\]
- Drink ≥ 48 standard drinks in a 30-day period before enrollment
Exclusion
- Currently in treatment for AUD, a history of treatment in the 30 days before enrollment, or currently treatment seeking
- Current (last 12 months) DSM-V diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- Lifetime DSM-V diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
- Positive urine screen for narcotics, amphetamines, or sedative hypnotics
- Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised
- Pregnancy, nursing, or refusal to use reliable method of birth control (if female)
- A medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
- AST, ALT, or GGT ≥ 3 times upper normal limit
- Attempted suicide in the past 3 years and/or serious suicidal intention or plan within the past year
- Currently on prescription medication that contraindicates use of MINO
- Any other circumstances that, in the opinion of the investigators, compromises participant safety.
- Claustrophobia
- 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.
- 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.
- low affinity rs6971 genotype
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03244592
Start Date
January 15 2018
End Date
March 1 2018
Last Update
January 24 2019
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