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Ibudilast for the Treatment of Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT03594435
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
MediciNova
Information provided by (Responsible Party):
Lara Ray, PhD, University of California, Los Angeles

Brief Summary:
This study is a double-blind, placebo-controlled randomized clinical trial of IBUD (50mg BID) for the treatment of Alcohol Use Disorder (AUD). Eligible participants will undergo a 12-week medication treatment period and 5 in-person visits over 16 weeks.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Ibudilast Drug: Placebo oral capsule Phase 2

Detailed Description:
The study design consists of a 12-week, double-blind, placebo-controlled randomized clinical trial of IBUD (50mg BID) for the treatment of Alcohol Use Disorder (AUD). The investigators will randomize 132 treatment-seekers with current AUD over the course of 4 years. As a behavioral support platform, all participants will complete the NIAAA-developed and computer-delivered program "Take Control" during the study. Participants will complete telephone screening, followed by in-person eligibility assessment, a physical exam for medical eligibility, randomization to study medication or matched placebo, and in-person follow-up visits at 4, 8, and 12 weeks of treatment. TLFB assessment of drinking outcomes will also occur by telephone on weeks 2, 6, and 10. A final safety check visit will occur on week 16, consisting of repeated clinical labs and ECG.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-Arm, Randomized, Double-Blind, Placebo-Controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of the Neuroimmune Modulator Ibudilast for the Treatment of Alcohol Use Disorder
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Ibudilast
10mg delayed-release capsules, target dose 50mg BID (5 x 10mg capsules twice daily) for 12 weeks
Drug: Ibudilast
targets neurotrophin signaling and neuroimmune function
Other Names:
  • Pinatos
  • MN-166

Placebo Comparator: Placebo Oral Capsule
matched to experimental drug
Drug: Placebo oral capsule
matched to active drug, ibudilast
Other Name: Sugar Pill




Primary Outcome Measures :
  1. Percent heavy drinking days [ Time Frame: 12 week-treatment period ]
    Heavy drinking days defined as 5+ drinks for men and 4+ for women


Secondary Outcome Measures :
  1. Drinks per day [ Time Frame: 12-week treatment period ]
    secondary alcohol consumption endpoint

  2. Drinks per drinking day [ Time Frame: 12-week treatment period ]
    secondary alcohol consumption endpoint

  3. Percent days abstinent [ Time Frame: 12-week treatment period ]
    secondary alcohol consumption endpoint

  4. Percent subjects with no heavy drinking days [ Time Frame: 12-week treatment period ]
    secondary alcohol consumption endpoint

  5. Percent subjects abstinent [ Time Frame: 12-week treatment period ]
    secondary alcohol consumption endpoint


Other Outcome Measures:
  1. Depressive Symptomatology [ Time Frame: 12-week treatment period ]
    Responses from Beck Depression Inventory II (BDI-II) will be used to test this outcome

  2. Neuroinflammation [ Time Frame: 12-week treatment period ]
    Blood levels of proinflammatory markers



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be between the ages of 18 and 65
  2. Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for alcohol use disorder moderate or severe
  3. Be treatment-seeking for AUD
  4. Report drinking at least 28 drinks per week if male (21 drinks per week if female) in the 28 days prior to consent

Exclusion Criteria:

  1. Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
  2. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
  3. Have a positive urine screen for narcotics, amphetamines, or sedative hypnotics;
  4. Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
  5. Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:

    • Oral contraceptives
    • Contraceptive sponge
    • Patch
    • Double barrier
    • Intrauterine contraceptive device
    • Etonogestrel implant
    • Medroxyprogesterone acetate contraceptive injection
    • Complete abstinence from sexual intercourse
    • Hormonal vaginal contraceptive ring
  6. Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
  7. Have AST, ALT, or GGT ≥ 3 times upper normal limit
  8. Have attempted suicide in the past 3 years and/or have had serious suicidal intention or plan in the past year
  9. Currently be on prescription medication that contraindicates use of IBUD, including alpha or beta agonists, theophylline, or other sympathomimetic
  10. Currently be on any medications for AUD or any psychotropic medications (e.g., psychostimulants and benzodiazepines) with the exception of stable antidepressants (stable dose for ≥4 weeks)
  11. Have any other circumstances that, in the opinion of the investigators, compromises participant safety.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594435


Contacts
Contact: Jessica Jenkins, MS 310-206-6756 jenkinsj@ucla.edu

Locations
United States, California
UCLA Addictions Laboratory Recruiting
Los Angeles, California, United States, 90095
Contact: Jessica Jenkins, MA    310-206-6756    raylab@psych.ucla.edu   
Principal Investigator: Lara Ray, PhD         
Sub-Investigator: Karen Miotto, MD         
Sub-Investigator: Gang Li, PhD         
Sub-Investigator: Michael Irwin, MD         
Sub-Investigator: Steven Shoptaw, PhD         
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
MediciNova
Investigators
Principal Investigator: Lara A. Ray, PhD University of California, Los Angeles

Responsible Party: Lara Ray, PhD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03594435     History of Changes
Other Study ID Numbers: 18-000963
R01AA026190 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lara Ray, PhD, University of California, Los Angeles:
ibudilast, treatment, medication development

Additional relevant MeSH terms:
Disease
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Ibudilast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents