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The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking

NCT04084860 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-11-07

No results posted yet for this study

Summary

The proposed project tests the efficacy of glutamate modulators in non-depressed individuals with alcohol use disorder (AUD); the primary hypothesis is that the glutamate modulator being tested reduces heavy drinking days compared to the active control. It also aims to investigate, using a 2 by 2 factorial (2x2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment.

Conditions

Interventions

DRUG

CI-581a

CI-581a during weeks 1 and 6 at 0.71 mg/kg

DRUG

CI-581b

CI-581b during weeks 1 and 6 at 0.0125 mg/kg

BEHAVIORAL

MBRP

MBRP will help with maintaining use reduction/abstinence.In this trial, 3 sessions will occur in the first 2 weeks following the second infusion (weeks 6 and 7), while one session a week will be administered in the latter 5 weeks (weeks 8 through 12).

BEHAVIORAL

MET

MET may help with goal setting and enhancing engagement with MBRP. In this trial, a standard 5-week MET platform will be provided to individuals randomized to receive behavioral treatment, with an additional session after each infusion (7 sessions total).

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Elias Dakwar, MD · NYSPI/Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-08
Primary Completion
2024-08-31
Completion
2024-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04084860 on ClinicalTrials.gov