A Novel Human Lab Model for Screening AUD Medications

NCT04249882 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 19-001735R21AA027180
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use Disorder; Medications Development

Outcome Measures

Primary Outcomes (3)

• Percentage of Days Abstinent

  The percentage of days abstinent from alcohol is determined using the Timeline Follow Back (TLFB). The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14). Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database. The primary outcome variable was calculated as the percent of days participants were abstinent during the practice quit period.

  6 days

• # of Drinks Per Drinking Day

  The drinks per drinking day outcome is determined using the the Timeline Follow Back (TLFB). The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14). Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database. The primary outcome variable was calculated as the number of drinks per drinking day during the practice quit period.

  6 days

• Cue-induced Craving

  Randomized participants completed a cue-exposure paradigm at two time points during the study, once on Day 1 prior to ingesting the first does of study medication, and again on Day 14. After every 3 minutes of exposure (water and alcohol), participants rated their urge to drink on the Alcohol Urge Questionnaire (AUQ). The AUQ is comprised of eight items rated on a 7-point Likert scale with items related to the subjective experience of alcohol craving, with higher total scores indicating higher craving and a minimum score of 8 and maximum score of 56. 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).

  Cue reactivity paradigm takes place on Day 1 and on Day 14. Craving is measured 3 min after each cue exposure

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matched to active medications

Drug: Placebo

Varenicline

ACTIVE COMPARATOR

1 mg twice a day

Drug: Varenicline

Naltrexone

ACTIVE COMPARATOR

50 mg once a day

Drug: Naltrexone

Interventions

Placebo DRUG

Matched to active medication

Also known as: PLAC

Placebo

Naltrexone DRUG

50 mg once a day

Also known as: NTX

Naltrexone

Varenicline DRUG

1 mg twice a day

Also known as: VAR, Chantix

Varenicline

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 21 and 65
• Meet current (i.e., past 12-month) DSM-5 diagnostic criteria for AUD moderate or severe
• Have intrinsic motivation to reduce or quit drinking (defined as self-reported intention to reduce or quit drinking within the next 6 months)
• 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
• Have reliable internet access

You may not qualify if:

• Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
• Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
• Have a positive urine screen for drugs other than cannabis
• Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
• Have an intense fear of needles or have had any adverse reactions to needle puncture
• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

UCLA Addictions Lab

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• Baskerville WA, Grodin EN, Meredith LR, Ray LA. Interplay between alcohol cues and mood states during early abstinence: A daily diary study. Exp Clin Psychopharmacol. 2025 Jun;33(3):260-268. doi: 10.1037/pha0000770. Epub 2025 Mar 13.

  PMID: 40080609 DERIVED

• Ho D, Towns B, Grodin EN, Ray LA. A novel human laboratory model for screening medications for alcohol use disorder. Trials. 2020 Nov 23;21(1):947. doi: 10.1186/s13063-020-04842-w.

  PMID: 33225963 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

5'-palmitoyl cytarabine; Naltrexone; Varenicline

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Quinoxalines

Results Point of Contact

• Title: Dr. Lara Ray
• Organization: University of California Los Angeles

lararay@psych.ucla.edu

310-206-6756

Study Officials

• Lara Ray, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study team, medical personnel, and participants will be blind to drug condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, double-blind, placebo-controlled, 3-arm, parallel-group study of naltrexone (50 mg QD) and varenicline (1 mg BID).

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 31, 2020
• Study Start: January 28, 2020
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)