MAP4343 Treatment for Alcohol Use Disorder

February 23, 2022 updated by: Barbara J. Mason, The Scripps Research Institute

A Double-Blind, Randomized, Controlled Trial of MAP4343 Treatment, a Ligand of the Neurospecific Microtubule Associated Protein-2, for Alcohol Use Disorder

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: MAP4343
Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling
Drug: MAP4343
Subjects will receive daily oral doses of MAP4343 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
Other Names:
  • Manually-guided therapy
PLACEBO_COMPARATOR: Placebo
Subjects will 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
Other Names:
  • Manually-guided therapy
Drug: Placebo
Subjects receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeline Follow-Back (TLFB) Interview
Time Frame: 90-day period prior to and throughout the study
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)
Time Frame: At subject's Week 2 human laboratory session
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Craving Questionnaire-Short Form (ACQ-SF)
Time Frame: Subjects will followed for up to 10 weeks
The Alcohol Craving Questionnaire-Short Form has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving.
Subjects will followed for up to 10 weeks
Beck Depression Inventory (BDI-II)
Time Frame: Subjects will be followed for up to 10 weeks
The Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0-3, summed for a weekly total score between 0 and 63, higher scores indicate more depression.
Subjects will be followed for up to 10 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Subjects will be followed for up to 10 weeks
The Pittsburgh Sleep Quality Index, modified for weekly administration, consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher scores indicating greater sleep impairment.
Subjects will be followed for up to 10 weeks
State-Trait Anxiety Inventory (STAI)
Time Frame: Subjects will be followed for up to 10 weeks
The State-Trait Inventory has 20 questions for assessing state anxiety and 20 for trait anxiety answered with scores between 1-4, summed for a weekly total score between 20 and 80, higher scores indicate more anxiety.
Subjects will be followed for up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Scripps Research Institute

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Mapreg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (ACTUAL)

November 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAP2019
  • P60AA006420 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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