RecruitingPhase 2NCT04084860

The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking

The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking: a Randomized, Controlled Trial


Sponsor

New York State Psychiatric Institute

Enrollment

120 participants

Start Date

Nov 8, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CI-581a, a drug called CI-581b, and others for people with alcohol use disorder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCI-581a

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

DRUGCI-581b

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

BEHAVIORALMBRP

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).

BEHAVIORALMET

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).


Locations(1)

NYSPI

New York, New York, United States

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NCT04084860


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