Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-12-31
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MAP4343
Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling
MAP4343
Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling
Standardized behavioral counseling
Subjects receive manually-guided counseling 1 time per week for a 6 week duration
Placebo
Subjects will receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling
Placebo
Subjects receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling
Standardized behavioral counseling
Subjects receive manually-guided counseling 1 time per week for a 6 week duration
Interventions
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MAP4343
Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling
Placebo
Subjects receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling
Standardized behavioral counseling
Subjects receive manually-guided counseling 1 time per week for a 6 week duration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Meets Diagnostic and Statistical Manual (DSM)-5 criteria for current Alcohol Use Disorder (AUD) of moderate or greater severity, defined by DSM-5 as ≥ 4 symptoms
3. In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (males: ≥ 5 drinks, females: ≥ 4 drinks) per week
4. Seeking research-based outpatient treatment for AUD and willing to comply with the protocol, take daily oral medication for 6 weeks and complete 10 study visits
5. Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
6. Negative Blood Alcohol Concentration (BAC) and a Clinical Institute Withdrawal Assessment (CIWA) score of ≤ 9 at randomization
7. In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, electrocardiogram (ECG), urine test, and routine lab tests
8. Females with childbearing potential must have a negative pregnancy test on both the screening and randomization visits and agree to use non-hormonal effective birth control for the study duration and 1 month post treatment.
9. Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent
Exclusion Criteria
2. Liver function tests more than 3 times the upper limit of normal
3. Meets DSM-5 criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders or mild cannabis use disorder
4. Urine drug test positive at screening for abused drugs other than cannabis. Subjects using cannabis will be excluded if they meet criteria for cannabis use disorder ≥ moderate level of severity
5. Treatment within the month prior to screening with an investigational drug or vaccine, or drugs that may influence study outcomes, e.g., disulfiram, naltrexone, acamprosate
6. Chronic use or need for psychotropic drugs. Note: some drugs with psychotropic properties (e.g., anti-hypertensive drugs) or antidepressant medication taken at a stable dose for ≥ 3 months and no longer meeting criteria for depressive or anxiety disorders are allowed if their use is judged by both the investigator and study physician not to pose a safety risk or impact the results of the study
7. No fixed domicile and/or no availability by home or mobile telephone
8. Treatment mandated by a legal authority
9. Failure to comply with study procedures
10. Subjects who require medical detoxification (Note: Subjects may proceed with study evaluation after completion of detoxification)
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Mapreg
INDUSTRY
The Scripps Research Institute
OTHER
Responsible Party
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Barbara J. Mason
Principal Investigator
Principal Investigators
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Barbara J. Mason, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Scripps Research Institute
Locations
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The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, United States
Countries
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Other Identifiers
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MAP2019
Identifier Type: -
Identifier Source: org_study_id
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