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A Novel Human Lab Model for Screening AUD Medications

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ClinicalTrials.gov Identifier: NCT04249882
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : June 1, 2021
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Lara Ray, PhD, University of California, Los Angeles

Brief Summary:
This study design consists of a randomized, double-blind, placebo-controlled, 3-arm, parallel-group study of naltrexone (50 mg QD) and varenicline (1 mg BID). A total of 108 men and women with current AUD (moderate or severe) and reporting intrinsic motivation to change their drinking, will be randomly assigned to receive naltrexone (50 mg QD), varenicline (1 mg BID) or matched placebo. Post-randomization, all participants will complete an alcohol cue-reactivity paradigm prior to the initial dose of study medication. After a week-long medication titration period, participants will be asked to complete a 7-day practice quit attempt, during which they will have daily virtual visits (phone and online) where they will report on their alcohol use. Additionally, a second cue-reactivity paradigm will be conducted 90 minutes following study drug administration on final day of the practice quit attempt (Day 14).

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Placebo Drug: Naltrexone Drug: Varenicline Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, 3-arm, parallel-group study of naltrexone (50 mg QD) and varenicline (1 mg BID).
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The study team, medical personnel, and participants will be blind to drug condition.
Primary Purpose: Treatment
Official Title: A Novel Human Laboratory Model for Screening Medications for Alcohol Use Disorder
Actual Study Start Date : January 28, 2020
Estimated Primary Completion Date : June 20, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Placebo Comparator: Placebo
Matched to active medications
Drug: Placebo
Matched to active medication

Active Comparator: Varenicline
1 mg twice a day
Drug: Varenicline
1 mg twice a day

Active Comparator: Naltrexone
50 mg once a day
Drug: Naltrexone
50 mg once a day




Primary Outcome Measures :
  1. Percentage of days abstinent [ Time Frame: 7 days ]
    The percentage of days abstinent from alcohol is determined using the the Timeline Follow Back (TLFB). The TLFB will be administered to assess quantity and frequency of alcohol, cigarette and marijuana use and will be completed at the initial screening (for the 30 days prior to that visit) and at each subsequent visit to gather data for every day prior to and including the last visit. Information obtained in this interview will be recorded on the TLFB Calendar and transcribed to a database.

  2. # of drinks per drinking day [ Time Frame: 7 days ]
    The number of alcohol drinks per alcohol drinking day is determined using the Timeline Follow Back (TLFB). The TLFB will be administered to assess quantity and frequency of alcohol, cigarette and marijuana use and will be completed at the initial screening (for the 30 days prior to that visit) and at each subsequent visit to gather data for every day prior to and including the last visit. Information obtained in this interview will be recorded on the TLFB Calendar and transcribed to a database.

  3. Cue-induced craving [ Time Frame: Cue reactivity paradigm takes place on Day 1 and on Day 14. Craving is measured 3 min after each cue exposure ]
    Alcohol urge questionnaire score (alcohol minus water) is the primary outcome for the cue-reactivity paradigm. The investigators are primarily interested in the difference in craving from post-treatment (day 14) to pre-treatment (randomization/day 1).



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Ages Eligible for Study:   21 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 21 and 65
  2. Meet current (i.e., past 12-month) DSM-5 diagnostic criteria for AUD moderate or severe
  3. Have intrinsic motivation to reduce or quit drinking (defined as self-reported intention to reduce or quit drinking within the next 6 months)
  4. Report drinking at least 28 drinks per week if male (14 drinks per week if female) in the 28 days prior to the initial consent
  5. Have reliable internet access

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 drugs other than cannabis
  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. Have an intense fear of needles or have had any adverse reactions to needle puncture
  6. 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
  7. Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
  8. Be currently taking any psychotropic medications that, in the opinion of the investigators, compromises participant safety
  9. Be currently taking or have had previous experience with either naltrexone or varenicline
  10. 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): NCT04249882


Contacts
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Contact: Lara Ray, PhD (310) 794-5383 lararay@psych.ucla.edu
Contact: Jessica Jenkins, MS 310-206-6756 jenkinsj@ucla.edu

Locations
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United States, California
UCLA Addictions Lab Recruiting
Los Angeles, California, United States, 90095
Contact: Jessica Jenkins, MS    310-206-6756    jenkinsj@ucla.edu   
Contact: Lara Ray, PhD    (310) 794-5383    lararay@psych.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Lara Ray, PhD University of California, Los Angeles
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lara Ray, PhD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04249882    
Other Study ID Numbers: 19-001735
R21AA027180 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Lara Ray, PhD, University of California, Los Angeles:
Alcohol Use Disorder
Medications Development
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Varenicline
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action