MAP4343 Treatment for Alcohol Use Disorder

NCT04157114 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: MAP2019P60AA006420
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

Alcohol-Related Disorders; Substance-Related Disorders; MAP4343; Alcohol Treatment; Alcohol

Outcome Measures

Primary Outcomes (2)

• Timeline Follow-Back (TLFB) Interview

  The Timeline Follow-Back Interview provides quantity and frequency estimates of alcohol consumption for the 90-day period prior to and throughout the study.

  90-day period prior to and throughout the study

• Visual Analogue Scale of Craving (VAS; adapted from ACQ)

  The Visual Analogue Scale of Craving has 4 questions to assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity with a 0-20 point visual analogue scale for each item, with 0 indicating no craving and 20 indicating severe craving.

  At subject's Week 2 human laboratory session

Secondary Outcomes (4)

• Alcohol Craving Questionnaire-Short Form (ACQ-SF)

  Subjects will followed for up to 10 weeks

• Beck Depression Inventory (BDI-II)

  Subjects will be followed for up to 10 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  Subjects will be followed for up to 10 weeks

• State-Trait Anxiety Inventory (STAI)

  Subjects will be followed for up to 10 weeks

Study Arms (2)

MAP4343

ACTIVE COMPARATOR

Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling

Drug: MAP4343; Behavioral: Standardized behavioral counseling

Placebo

PLACEBO COMPARATOR

Subjects will receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling

Drug: Placebo; Behavioral: Standardized behavioral counseling

Interventions

MAP4343 DRUG

Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling

MAP4343

Placebo DRUG

Subjects receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling

Placebo

Standardized behavioral counseling BEHAVIORAL

Subjects receive manually-guided counseling 1 time per week for a 6 week duration

Also known as: Manually-guided therapy

MAP4343; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female volunteers, 18-65 years of age
• 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
• 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
• 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
• Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
• Negative Blood Alcohol Concentration (BAC) and a Clinical Institute Withdrawal Assessment (CIWA) score of ≤ 9 at randomization
• 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
• 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.
• Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent

You may not qualify if:

• 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
• Liver function tests more than 3 times the upper limit of normal
• 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
• 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
• 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
• 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
• No fixed domicile and/or no availability by home or mobile telephone
• Treatment mandated by a legal authority
• Failure to comply with study procedures
• Subjects who require medical detoxification (Note: Subjects may proceed with study evaluation after completion of detoxification)

Sponsors & Collaborators

• The Scripps Research Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Mapreg: collaborator

Study Sites (1)

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Barbara J. Mason, Ph.D.

  The Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)