Minocycline for Alcohol Use Disorder

NCT03244592 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: K01AA026005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 treatment. This study has important clinical implications, as the available treatments for alcohol use disorder are only modestly effective and testing novel medications is a high research priority.

Conditions

Alcohol Use Disorder; Inflammation; Neurocognitive Dysfunction; Craving; Alcohol Drinking

Keywords

Minocycline

Outcome Measures

Primary Outcomes (11)

• Microglial Activation

  Level of \[11C\]DAA1106 binding during PET imaging

  Change from baseline after 28 days of medication dosing

• Cue-Induced Alcohol Craving

  Alcohol Urge Questionnaire (AUQ)

  Change from baseline after 28 days of medication dosing

• Alcohol consumption

  Total drinks consumed

  Day 28 of medication dosing period

• Verbal Learning and Memory

  Hopkins Verbal Learning Test

  Change from baseline after 28 days of medication dosing

• Set-Shifting

  Wisconsin Card Sorting Test

  Change from baseline after 28 days of medication dosing

• Response Inhibition

  Stop Signal Task

  Change from baseline after 28 days of medication dosing

• Manipulative Dexterity

  Grooved Pegboard Test

  Change from baseline after 28 days of medication dosing

• Executive Function

  Digit Symbol Substitution Test

  Change from baseline after 28 days of medication dosing

• Memory

  Digit Span

  Change from baseline after 28 days of medication dosing

• Vocabulary

  WAIS Vocabulary

  Change from baseline after 28 days of medication dosing

• Executive Function

  Rey Complex Figure Copy

  Change from baseline after 28 days of medication dosing

Secondary Outcomes (2)

• Peripheral Proinflammatory Marker levels

  At baseline (day zero) and after 7, 14, and 21 and 28 days of medication dosing

• Alcohol Use Disorder Severity

  At baseline (day zero) and after 28 days of medication dosing

Study Arms (2)

Minocycline

ACTIVE COMPARATOR

200 mg/day

Drug: Minocycline

Sugar Pill

PLACEBO COMPARATOR

Matched placebo

Drug: Sugar pill

Interventions

Minocycline DRUG

200 mg/day

Minocycline

Sugar pill DRUG

Matched placebo

Also known as: Placebo

Sugar Pill

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

MeSH Terms

Conditions

Alcoholism; Inflammation; Cognition Disorders; Alcohol Drinking; cyclopia sequence

Interventions

Minocycline; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbohydrates

Study Officials

• Daniel Roche, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 9, 2017
• Study Start: January 15, 2018
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share