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Human Laboratory Study of ASP8062 for Alcohol Use Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Human Laboratory Study of ASP8062 for Alcohol Use Disorder

NCT05096117•National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be at least 21 years of age.
•2. Meet the DSM-5 criteria for AUD of at least moderate severity.
•3. Be seeking treatment for AUD and desire a reduction or cessation of drinking.
•4. 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.
•5. 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):
•1. oral contraceptives,
•2. contraceptive sponge,
•3. patch,
•4. double barrier (diaphragm/spermicidal or condom/spermicidal),
•5. intrauterine contraceptive system,
+32 more criteria

Exclusion Criteria

•1. 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.
•2. Be mandated by the court to obtain treatment for alcohol-dependence, or has probation or parole requirements that might interfere with study participation.
•3. Be anyone who in the opinion of the investigator could not be safely withdrawn from alcohol without medical detoxification.
•4. Have any of the following, based on DSM-5 criteria as assessed using theMINI:
•1. Current or lifetime diagnosis of psychotic disorders,
•2. Current bipolar disorder,
•3. Current major depressive episode,
•4. Current (past 3 months) eating disorder (anorexia or bulimia), or
•5. Within past year diagnosis of panic disorder with or without agoraphobia.
•\-

Locations (3)

University of California Los Angeles

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

Brown University

Providence, Rhode Island, United States

Key Dates

Start Date

December 13, 2021

Primary Completion Date

March 22, 2023

Completion Date

March 22, 2023

Last Updated

December 3, 2024

Enrollment

ACTUAL participants

Conditions

Alcohol Use DisorderAlcohol DrinkingAlcohol Use Disorder (AUD)

Interventions

ASP8062

DRUG

Placebo

DRUG

Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment

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Alcohol Use DisorderCannabis Use Disorder

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RECRUITINGNA

Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder

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Alcohol Use Disorder (AUD)Cocaine Use Disorder (CUD)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Human Laboratory Study of ASP8062 for Alcohol Use Disorder

Inclusion Criteria

Exclusion Criteria

Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment

Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder

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Anxiety During Abstinence in AUD

Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

Image-guided, Robot Navigated Transcranial Magnetic Stimulation (IR-TMS) for Alcohol Use Disorder (AUD)