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MAP4343 Treatment for Alcohol Use Disorder

NCT04157114 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-03-11

No results posted yet for this study

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

Interventions

DRUG

MAP4343

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

DRUG

Placebo

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

BEHAVIORAL

Standardized behavioral counseling

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Mapreg

    collaborator INDUSTRY

  • The Scripps Research Institute

    lead OTHER

Principal Investigators

  • Barbara J. Mason, Ph.D. · The Scripps Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04157114 on ClinicalTrials.gov