Development of Ibudilast for Alcohol Use Disorder

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02025998
Study type	Interventional
Source	University of California, Los Angeles
Contact
Status	Completed
Phase	Phase 1
Start date	December 2013
Completion date	June 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02179749` - Mifepristone Treatment of Alcohol Use Disorder	Phase 2
Completed	`NCT02113618` - Effect of Cognitive Training on Alcohol Use Outcomes	N/A
Completed	`NCT01008280` - Baclofen to Reduce Alcohol Use in Veterans With HCV	Phase 4
Active, not recruiting	`NCT02671019` - Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care	N/A
Completed	`NCT01751035` - Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD	N/A
Active, not recruiting	`NCT03695653` - Messaging Interventions to Reduce Alcohol Problems Project	N/A
Completed	`NCT02298751` - Exposure Therapy as Aftercare for Alcohol Use Disorder	N/A
Terminated	`NCT01566370` - Zonisamide for Heavy Drinkers With Bipolar Disorder	Phase 2
Completed	`NCT01642381` - Component Analysis for Motivational Interviewing	N/A
Completed	`NCT02511808` - Adaptive Interventions for Problem Drinkers	N/A
Completed	`NCT02384278` - Internet Based Cognitive Behavior Treatment for Alcohol Problems	N/A
Completed	`NCT01613014` - ABT-436 for Alcohol Dependence	Phase 2
Completed	`NCT02905162` - Understanding Longitudinal Clinical Outcomes and Post-release Retention in Care Among HIV-infected Prisoners in Lusaka, Zambia
Completed	`NCT02808468` - Brief Restructuring Intervention Following Trauma Exposure	N/A
Completed	`NCT01692054` - Risk and Protective Factors of Children and Adolescents Who Were Hospitalized Due to Alcohol Intoxication	N/A
Completed	`NCT02500602` - CAP: Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders	Phase 2
Active, not recruiting	`NCT02713217` - Implementing a Blended Care Model That Integrates Mental Healthcare and Primary Care Using Telemedicine and Care Management for Patients With Depression or Alcohol Use Disorder in Small Primary Care Clinics
Recruiting	`NCT02465177` - Tailoring Screening, Brief Intervention, and Referral to Treatment for Medical ICU Survivors
Completed	`NCT02193256` - Varenicline + Prazosin for Heavy Drinking Smokers	Early Phase 1
Completed	`NCT01172210` - Examining Common Substrates of Eating and Alcohol Use Disorders	N/A