Alcohol Use DisorderPhase 2NCT05096117
Human Laboratory Study of ASP8062 for Alcohol Use Disorder
A Phase 2 study testing ASP8062 in people with Alcohol Use Disorder and Alcohol Drinking, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Drinking, Alcohol Use Disorder (AUD)
- What is being tested?
- ASP8062
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Dec 2021to 22 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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,
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- 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.
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado
Aurora, Colorado, 80045
University of California Los Angeles
Los Angeles, California, 90095
Brown University
Providence, Rhode Island, 02912
About this study
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.
- Being tested
- ASP8062, Placebo
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP8062Drug
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
PlaceboDrug
1 x per day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| ASP8062 (25 mg once daily) | Experimental | Not described Receives: Drug: ASP8062 |
| Matching Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Craving
Strength of alcohol craving Visual Analogue Scale (VAS) score; min=0, max=20; higher scores = more craving (worse outcome)
Measured: Week 3
Secondary outcomes (13)
Number of Subjects With no Heavy Drinking Days
Number of subjects that have no heavy drinking days during weeks 3 to 6 of the treatment phase. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Measured: Weeks 3 to 6 of the treatment phase
Number of Subjects Abstinent From Alcohol
Number of subjects that have not drank alcohol during Weeks 3 to 6 of the treatment phase.
Measured: Weeks 3 to 6 of the treatment phase
WHO 1-level Decrease in Alcohol Consumption
The number of subjects experiencing at least a 1-level decrease in World Health Organization (WHO) levels of alcohol consumption from the level at baseline (the period including the 28 days before screening) to the level during Weeks 3 to 6 of the treatment phase.
The WHO levels of average alcohol consumption per day are as follows:
Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category.
Measured: Weeks 3 to 6 of the treatment phase
WHO 2-level Decrease in Alcohol Consumption
The number of subjects experiencing at least a 2-level decrease in World Health Organization (WHO) levels of alcohol consumption from the level at baseline (the period including the 28 days before screening) to the level during Weeks 3 to 6 of the treatment phase.
The WHO levels of average alcohol consumption per day are as follows:
Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category.
Measured: Weeks 3 to 6 of the treatment phase.
Percentage of Days Abstinent
The percentage of days abstinent from drinking alcohol
Measured: Weeks 3 to 6 of the treatment phase
Percentage of Heavy Drinking Days
Percentage of heavy drinking days where a heavy drinking day is 4 or more drinks on a day for women or 5 or more drinks on a day for men.
Measured: Weeks 3 to 6 of the treatment phase
Drinks Per Week
The number of drinks consumed per week
Measured: Weeks 3 to 6 of the treatment phase
Drinks Per Drinking Day
The number of drinks consumed on days where participants drank
Measured: Weeks 3 to 6 of the treatment phase
Penn Alcohol Craving Scale (PACS)
The amount of craving; higher numbers indicate more craving. There are 5 items each on a 0 to 6 scale. Items are summed to get to the total craving, resulting in scores having a min=0 and max=30.
Measured: Weeks 3 to 6 during the treatment phase, averaged
Pittsburgh Sleep Quality Index (PSQI)
A measure of sleep quality; the PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Measured: Weeks 4 & 6 of the treatment phase, averaged
Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Related Negative Consequences
A measure of alcohol-related negative consequences. There are 7 items scored on a 1 to 7 scale (a higher score indicative greater frequency of negative consequences). The items are summed and converted to a T-score to create a total score. The T-scores range from 0 to 100 (the population mean = 50 and standard deviation = 10). Higher T-scores are indicative of more negative consequences (worse outcome).
Measured: Week 6 of the treatment phase
Profile of Mood States (POMS) Total Disturbance
A measure of total mood disturbance. Total mood disturbance is the sum of depression, anger, fatigue, confusion, and tension subscales subtracting the vigor subscale items. The range of possible scores is from -32 to 200 with higher scores indicating greater mood disturbance.
Measured: Weeks 4 & 6 of the treatment phase, averaged
Cigarettes Smoked Per Day (Among Smokers)
The number of cigarettes smoked per day, computed among individuals who smoked at baseline
Measured: Weeks 3 to 6 of the treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start13 Dec 2021
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Raye Litten, Ph.D., Study director, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096117
- Sponsor's protocol ID
- HLAB-003
- Status last verified
- Nov 2024
- First submitted
- 19 Oct 2021
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and supporting information will be shared with the general research community upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Laboratory Study of ASP8062 for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05096117
- Acronym / sponsor ID
- HLAB-003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Collaborators
- Astellas Pharma Inc
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP8062 (25 mg once daily) | Experimental | Drug: ASP8062 |
| Matching Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (42 listed)
- 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):
Key exclusion criteria (11 listed)
- 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:
- Contact site for additional exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP8062ASP8062 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 | Drug | ASP8062 (25 mg once daily) |
| Placebo1 x per day for 6 weeks | Drug | Matching Placebo |
Primary outcome
Alcohol Craving
Time frame: Week 3
Strength of alcohol craving Visual Analogue Scale (VAS) score; min=0, max=20; higher scores = more craving (worse outcome)
13 secondary outcomes
Number of Subjects With no Heavy Drinking Days
Time frame: Weeks 3 to 6 of the treatment phase
Number of Subjects Abstinent From Alcohol
Time frame: Weeks 3 to 6 of the treatment phase
WHO 1-level Decrease in Alcohol Consumption
Time frame: Weeks 3 to 6 of the treatment phase
WHO 2-level Decrease in Alcohol Consumption
Time frame: Weeks 3 to 6 of the treatment phase.
Percentage of Days Abstinent
Time frame: Weeks 3 to 6 of the treatment phase
Percentage of Heavy Drinking Days
Time frame: Weeks 3 to 6 of the treatment phase
Drinks Per Week
Time frame: Weeks 3 to 6 of the treatment phase
Drinks Per Drinking Day
Time frame: Weeks 3 to 6 of the treatment phase
Penn Alcohol Craving Scale (PACS)
Time frame: Weeks 3 to 6 during the treatment phase, averaged
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Weeks 4 & 6 of the treatment phase, averaged
Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Related Negative Consequences
Time frame: Week 6 of the treatment phase
Profile of Mood States (POMS) Total Disturbance
Time frame: Weeks 4 & 6 of the treatment phase, averaged
Cigarettes Smoked Per Day (Among Smokers)
Time frame: Weeks 3 to 6 of the treatment phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data and supporting information will be shared with the general research community upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raye Litten, Ph.D. study director
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP8062 in people with Alcohol Use Disorder and Alcohol Drinking, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 42 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Craving (time frame: Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.