Human Laboratory Study of ASP8062 for Alcohol Use Disorder

NCT05096117 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HLAB-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary objectives include evaluation of ASP8062, 25 mg once a day, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

Conditions

Alcohol Use Disorder; Alcohol Drinking; Alcohol Use Disorder (AUD)

Outcome Measures

Primary Outcomes (1)

• Alcohol Craving

  Strength of alcohol craving Visual Analogue Scale (VAS) score; min=0, max=20; higher scores = more craving (worse outcome)

  Week 3

Secondary Outcomes (13)

• Number of Subjects With no Heavy Drinking Days

  Weeks 3 to 6 of the treatment phase

• Number of Subjects Abstinent From Alcohol

  Weeks 3 to 6 of the treatment phase

• WHO 1-level Decrease in Alcohol Consumption

  Weeks 3 to 6 of the treatment phase

• WHO 2-level Decrease in Alcohol Consumption

  Weeks 3 to 6 of the treatment phase.

• Percentage of Days Abstinent

  Weeks 3 to 6 of the treatment phase

Study Arms (2)

ASP8062 (25 mg once daily)

EXPERIMENTAL

Drug: ASP8062

Matching Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ASP8062 DRUG

ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks

ASP8062 (25 mg once daily)

Placebo DRUG

1 x per day for 6 weeks

Matching Placebo

Eligibility Criteria

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

You may qualify if:

• Be at least 21 years of age.
• Meet the DSM-5 criteria for AUD of at least moderate severity.
• Be seeking treatment for AUD and desire a reduction or cessation of drinking.
• Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
• Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control to at least 30 days post the last dose of study drug, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal (one year):
• oral contraceptives,
• contraceptive sponge,
• patch,
• double barrier (diaphragm/spermicidal or condom/spermicidal),
• intrauterine contraceptive system,
• etonogestrel implant,
• medroxyprogesterone acetate contraceptive injection,
• true abstinence: when this is in line with the preferred and usual lifestyle of the participant,
• and/or hormonal vaginal contraceptive ring.
• Agree (if female) to not donate ova for at least 30 days following the last ASP8062 administration.

You may not qualify if:

• Current (past 12 months) substance use disorder of at least moderate severity (4 or more criteria) for any psychoactive substance other than alcohol and nicotine, including sedatives and hypnotics, or cocaine use disorder of any severity as defined by DSM-5 criteria.
• Be mandated by the court to obtain treatment for alcohol-dependence, or has probation or parole requirements that might interfere with study participation.
• Be anyone who in the opinion of the investigator could not be safely withdrawn from alcohol without medical detoxification.
• Have any of the following, based on DSM-5 criteria as assessed using theMINI:
• Current or lifetime diagnosis of psychotic disorders,
• Current bipolar disorder,
• Current major depressive episode,
• Current (past 3 months) eating disorder (anorexia or bulimia), or
• Within past year diagnosis of panic disorder with or without agoraphobia.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead
• Astellas Pharma Inc: collaborator

Study Sites (3)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Interventions

ASP8062

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Daniel Falk
• Organization: National Institute on Alcohol Abuse and Alcoholism

falkde@mail.nih.gov

3014430788

Study Officials

• Raye Litten, Ph.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 27, 2021
• Study Start: December 13, 2021
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available approximately 6/25/2025 for an indefinite time period
• Access Criteria: Data users will be encouraged to complete a Data Use Agreement and obtain authorization for data use by the NIAAA Data Access Committee.

Locations

US (3)