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Human Laboratory Study of ASP8062 for Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05096117
Recruitment Status : Completed
First Posted : October 27, 2021
Last Update Posted : June 7, 2023
Astellas Pharma Inc
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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) and nicotine use (among nicotine users), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Alcohol Drinking Alcohol Use Disorder (AUD) Drug: ASP8062 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Human Laboratory Study of ASP8062 for Alcohol Use Disorder
Actual Study Start Date : December 13, 2021
Actual Primary Completion Date : March 22, 2023
Actual Study Completion Date : March 22, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Active Medication Drug: ASP8062
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

Placebo Comparator: Matching Placebo Drug: Placebo
1 x per day for 6 weeks

Primary Outcome Measures :
  1. Alcohol Craving [ Time Frame: Week 3 ]
    Strength of alcohol craving VAS score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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,
    6. etonogestrel implant,
    7. medroxyprogesterone acetate contraceptive injection,
    8. true abstinence: when this is in line with the preferred and usual lifestyle of the participant,
    9. and/or hormonal vaginal contraceptive ring.
  6. Agree (if female) to not donate ova for at least 30 days following the last ASP8062 administration.
  7. Agree (if male) to use acceptable methods of contraception if the male participant's partner could become pregnant from the time of the first administration of the study drug until 90 days following the final administration of the study drug. One of the following acceptable methods of contraception must be utilized:

    1. surgical sterilization (vasectomy);
    2. the participant's female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or sub dermal implants (commenced at least 14 days prior to study drug administration to the male participant)
    3. the participant's female partner uses a medically prescribed topically applied transdermal contraceptive patch (commenced at least 14 days prior to study drug administration to the male participant);
    4. the participant's female partner has undergone tubal ligation (female sterilization) or is postmenopausal (one year);
    5. the participant's female partner has undergone placement of an intrauterine device or intrauterine system; and,
    6. true abstinence: when this is in line with the preferred and usual lifestyle of the participant.
  8. Agree (if male) to refrain from sperm donation from the randomization visit to at least 90 days after the last dose of study drug.
  9. Be able to take oral medication and be willing to adhere to the medication regimen.
  10. Complete all assessments required at screening and baseline.
  11. Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing in the next 2 months.

    Not anticipate any significant problems with transportation arrangements or available time to travel to the study site over the next 2 months.

  12. Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
  13. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
  14. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document.
  15. If taking a medication for depression or anxiety, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following:

    1. Selective serotonin reuptake inhibitors (SSRIs)
    2. Dual uptake inhibitors
    3. Serotonin-norepinephrine reuptake inhibitors (SNRIs)
    4. Tricyclic antidepressants
  16. Be someone who in the opinion of the investigator would be expected to complete the study protocol.
  17. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
  18. Be willing to use a smartphone's video capability to record daily oral ingestion of tablets for the entire 6-week treatment period (subject's own smartphone or one provided by AiCure).
  19. Have sitting (3 to 5 minutes) vital signs at the screening visit within the following limits:

    1. Systolic blood pressure 90 to 140 mmHg
    2. Diastolic blood pressure of 50 to 90 mmHg
    3. Heart rate of 40 to 90 beats per minute

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.

Contact site for additional exclusion criteria.


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 identifier (NCT number): NCT05096117

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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Astellas Pharma Inc
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Study Director: Raye Litten, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier: NCT05096117    
Other Study ID Numbers: HLAB-003
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: June 7, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcohol Drinking
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action