Development of Ibudilast for Alcohol Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ibudilast for the Treatment of Alcohol Use Disorder

NCT03594435

Alcohol Use Disorder

COMPLETED PHASE2

Ibudilast and Withdrawal-Related Dysphoria

NCT03489850

Alcohol Use Disorder

COMPLETED PHASE2

Ibudilast for Treating Alcohol Use Disorder

NCT05414240

Alcohol Use Disorder (AUD) Alcoholism

ACTIVE_NOT_RECRUITING PHASE2

Development of a Selective ALDH2 Inhibitor to Treat AUD

NCT04311294

Alcohol Use Disorder

WITHDRAWN PHASE2

Development of Ivermectin for Alcohol Use Disorders

NCT02046200

Alcohol Use Disorder

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Alcohol dependence (AD) is a chronic and relapsing condition affecting 10 million Americans. To date, only four pharmacotherapies are approved by the FDA for the treatment of alcoholism and their efficacy is modest. Therefore, medication development for AD represents a high priority area. Ibudilast (IBUD) is a glial cell modulator that inhibits phosphodiesterases (PDE) -4 and -10 and macrophage migration inhibitory factor (MIF). Preclinical data suggest that neuroimmune modulation is critical to the rewarding properties of drugs of abuse, including alcohol. Further, IBUD has been shown to enhance GDNF release in vivo and GDNF modulation has been implicated in alcohol reinstatement in animals, while PDE inhibition has been shown to reduce alcohol intake in mice. Together, these findings suggest that neuroimmune modulation constitutes a novel target for the treatment of alcoholism. The objective of this study is to advance medication development for alcoholism by conducting an initial Phase II study of IBUD for AD. Specifically, the proposed study consists of a randomized, double-blind, placebo-controlled within-subject crossover design to determine the safety, tolerability, and initial human laboratory efficacy of IBUD in a sample of 24 non-treatment seeking individuals with either alcohol abuse or dependence treated with IBUD (50mg BID) and placebo. Participants will complete two separate 7-day inpatient stays at the UCLA CTRC during which they will take the study medication, complete an IV alcohol challenge, and take part in a stress-exposure and cue-exposure paradigms. Specific aims are to test whether IBUD (a) is safe in the context of alcohol administration, (b) attenuates alcohol-induced reinforcement, and (c) dampens stress-induced and cue-induced alcohol craving. In sum, this study will efficiently evaluate safety and initial efficacy of IBUD thereby screening novel medications for AD and elucidating potential mechanisms by which IBUD may be clinically efficacious. Results from this study will inform whether a randomized controlled trial of IBUD for alcoholism is warranted.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Use Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ibudilast

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

Group Type EXPERIMENTAL

Ibudilast

Intervention Type DRUG

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

Sugar pill

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

Group Type PLACEBO_COMPARATOR

Matched placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ibudilast

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

Intervention Type DRUG

Matched placebo

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MN-166, AV411 Suggar pill

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No