Clinical trial NCT04157114: MAP4343 Treatment for Alcohol Use Disorder
Official title: A Double-Blind, Randomized, Controlled Trial of MAP4343 Treatment, a Ligand of the Neurospecific Microtubule Associated Protein-2, for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: Alcohol-Related Disorders
Substance-Related Disorders
MAP4343
Alcohol Treatment
Alcohol
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Mapreg
First posted: 2019-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, single-site, randomized, double-blind, placebo-controlled, proof-of-concept (POC) study involving 6 weeks of MAP4343 in conjunction with 6 weeks of manual-guided counseling, with 2 follow-up visits at 1 week and 1 month post-treatment.


Eligibility criteria: Inclusion Criteria:

1. Male or female volunteers, 18-65 years of age
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:

1. Significant medical disorders or clinically significant findings on ECG, urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician
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)

Primary outcomes:
measure: Timeline Follow-Back (TLFB) Interview
timeFrame: 90-day period prior to and throughout the study
measure: Visual Analogue Scale of Craving (VAS; adapted from ACQ)
timeFrame: At subject's Week 2 human laboratory session
Secondary outcomes:
measure: Alcohol Craving Questionnaire-Short Form (ACQ-SF)
timeFrame: Subjects will followed for up to 10 weeks
measure: Beck Depression Inventory (BDI-II)
timeFrame: Subjects will be followed for up to 10 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Subjects will be followed for up to 10 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Subjects will be followed for up to 10 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Barbara J. Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: