- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05096117
Human Laboratory Study of ASP8062 for Alcohol Use Disorder
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- University of California Los Angeles
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Rhode Island
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Providence, Rhode Island, United States, 02912
- Brown University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
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:
- surgical sterilization (vasectomy);
- 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)
- 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);
- the participant's female partner has undergone tubal ligation (female sterilization) or is postmenopausal (one year);
- the participant's female partner has undergone placement of an intrauterine device or intrauterine system; and,
- true abstinence: when this is in line with the preferred and usual lifestyle of the participant.
- Agree (if male) to refrain from sperm donation from the randomization visit to at least 90 days after the last dose of study drug.
- Be able to take oral medication and be willing to adhere to the medication regimen.
- Complete all assessments required at screening and baseline.
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.
- Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
- 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.
- Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document.
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:
- Selective serotonin reuptake inhibitors (SSRIs)
- Dual uptake inhibitors
- Serotonin-norepinephrine reuptake inhibitors (SNRIs)
- Tricyclic antidepressants
- Be someone who in the opinion of the investigator would be expected to complete the study protocol.
- 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.
- 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).
Have sitting (3 to 5 minutes) vital signs at the screening visit within the following limits:
- Systolic blood pressure 90 to 140 mmHg
- Diastolic blood pressure of 50 to 90 mmHg
- Heart rate of 40 to 90 beats per minute
Exclusion Criteria:
- 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.
Contact site for additional exclusion criteria.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Matching Placebo
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1 x per day for 6 weeks
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Experimental: Active Medication
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Craving
Time Frame: Week 3
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Strength of alcohol craving VAS score
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Week 3
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Raye Litten, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcohol Drinking
- Alcoholism
- Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- GABA Modulators
- GABA Agents
- ASP8062
Other Study ID Numbers
- HLAB-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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