NCT02025998

Brief Summary

The objective of this proposal is to advance medication development for alcoholism by conducting a safety and initial efficacy study of ibudilast, a neuroimmune modulator and phosphodiesterase inhibitor, for alcohol use disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

December 19, 2013

Last Update Submit

February 19, 2016

Conditions

Alcohol Use Disorders

Keywords

ibudilast, alcoholism

Outcome Measures

Primary Outcomes (1)

  • Subjective response to alcohol

    Biphasic Alcohol Effects Scale (BAES) Alcohol Urge Questionnaire (AUQ)

    During the alcohol administration and observation period which is expected to last a total of 4 hours

Secondary Outcomes (2)

  • Stress-Induced Craving

    During the stress exposure and observation period which is expected to last a total of 2 hours

  • Cue-Induced Alcohol Craving

    During the cue-exposure and observation period which is expected to last a total of 2 hours

Study Arms (2)

Ibudilast

EXPERIMENTAL

Ibudilast will be administered for 7 days at the target dose of 50 mg/bid

Drug: Ibudilast

Sugar pill

PLACEBO COMPARATOR

Placebo pills will be administered for 7 days and taken twice daily

Other: Matched placebo

Interventions

IbudilastDRUG

Ibudilast is a glial cell modulator that inhibits phosphodiesterases -4 and -10 and macrophage migration inhibitory factor.

Also known as: MN-166, AV411
Ibudilast
Matched placeboOTHER

A matched placebo (suggar pill) will be administered as a control condition.

Also known as: Suggar pill
Sugar pill

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 21 and 65
  • meet DSM-IV diagnostic criteria for alcohol abuse or dependence
  • report drinking at least 48 standard drinks in a 30-day period, during the 90 days before enrollment

You may not qualify if:

  • current treatment for alcohol problems, a history of treatment in the 30 days before enrollment or current treatment seeking;
  • current (last 12 months) DSM-IV diagnosis of dependence on any psychoactive substances other than alcohol and nicotine;
  • lifetime DSM-IV 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 (CIWA-R);
  • pregnancy, nursing, or refusal to use reliable method of birth control (if female);
  • 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 in the past year;
  • currently on prescription medication that contraindicates use of IBUD;
  • any other circumstances that, in the opinion of the investigators, compromises participant safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Addictions Laboratory

Los Angeles, California, 90095, United States

Location

Related Publications (2)

  • Meredith LR, Green R, Grodin EN, Chorpita M, Miotto K, Ray LA. Ibudilast moderates the effect of mood on alcohol craving during stress exposure. Exp Clin Psychopharmacol. 2022 Oct;30(5):620-631. doi: 10.1037/pha0000458. Epub 2021 Apr 22.

    PMID: 36102596DERIVED

  • Cummings JR, Tomiyama AJ, Ray LA. Does the Neuroimmune Modulator Ibudilast Alter Food Craving? Results in a Sample With Alcohol Use Disorder. J Addict Med. 2018 Sep/Oct;12(5):410-417. doi: 10.1097/ADM.0000000000000416.

    PMID: 29794557DERIVED

Related Links

MeSH Terms

Conditions

Alcoholism

Interventions

ibudilast

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Lara Ray, 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
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 19, 2013

First Posted

January 1, 2014

Study Start

December 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)