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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 10, 2019
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
MediciNova
Information provided by (Responsible Party):
Lara Ray, PhD, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Percent heavy drinking days [ Time Frame: 12 week-treatment period ]
Heavy drinking days defined as 5+ drinks for men and 4+ for women
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Drinks per day [ Time Frame: 12-week treatment period ]
    secondary alcohol consumption endpoint
  • Drinks per drinking day [ Time Frame: 12-week treatment period ]
    secondary alcohol consumption endpoint
  • Percent days abstinent [ Time Frame: 12-week treatment period ]
    secondary alcohol consumption endpoint
  • Percent subjects with no heavy drinking days [ Time Frame: 12-week treatment period ]
    secondary alcohol consumption endpoint
  • Percent subjects abstinent [ Time Frame: 12-week treatment period ]
    secondary alcohol consumption endpoint
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2018)
  • Depressive Symptomatology [ Time Frame: 12-week treatment period ]
    Responses from Beck Depression Inventory II (BDI-II) will be used to test this outcome
  • Neuroinflammation [ Time Frame: 12-week treatment period ]
    Blood levels of proinflammatory markers
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ibudilast for the Treatment of Alcohol Use Disorder
Official Title  ICMJE A Randomized Controlled Clinical Trial of the Neuroimmune Modulator Ibudilast for the Treatment of Alcohol Use Disorder
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • Drug: Ibudilast
    targets neurotrophin signaling and neuroimmune function
    Other Names:
    • Pinatos
    • MN-166
  • Drug: Placebo oral capsule
    matched to active drug, ibudilast
    Other Name: Sugar Pill
Study Arms  ICMJE
  • Experimental: Ibudilast
    10mg delayed-release capsules, target dose 50mg BID (5 x 10mg capsules twice daily) for 12 weeks
    Intervention: Drug: Ibudilast
  • Placebo Comparator: Placebo Oral Capsule
    matched to experimental drug
    Intervention: Drug: Placebo oral capsule
Publications * Burnette EM, Baskerville WA, Grodin EN, Ray LA. Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial. Trials. 2020 Sep 11;21(1):779. doi: 10.1186/s13063-020-04670-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jessica Jenkins, MS 310-206-6756 jenkinsj@ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03594435
Other Study ID Numbers  ICMJE 18-000963
R01AA026190 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lara Ray, PhD, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • MediciNova
Investigators  ICMJE
Principal Investigator: Lara A. Ray, PhD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP