The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking

Part of paid clinical trials in New York, New York.

Sponsor
New York State Psychiatric Institute
Study ID
NCT04084860
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CI-581a — DRUG
    CI-581a during weeks 1 and 6 at 0.71 mg/kg
  • CI-581b — DRUG
    CI-581b during weeks 1 and 6 at 0.0125 mg/kg
  • MBRP — BEHAVIORAL
    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).
  • MET — BEHAVIORAL
    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).

Study Details

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.

Key Dates

Start date
Nov 8, 2019
Status verified
Nov 2023
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CI-581a + MET/MBRP
    Administration of CI-581a during weeks 1 and 6 at 0.71 mg/kg in the context of a 12 wk outpatient treatment (behavioral treatment combination of MET/MBRP will be provided)
  • Experimental: CI-581a + Medication Management
    Administration of CI-581a during weeks 1 and 6 at 0.71 mg/kg in the context of a 12 wk outpatient treatment ( no MET/MBRP sessions will be provided, only general check-ins and psychiatrist visits)
  • Active Comparator: CI-581b + MET/MBRP
    Administration of CI-581b during weeks 1 and 6 at 0.0125 mg/kg in the context of a 12 wk outpatient treatment (behavioral treatment combination of MET/MBRP will be provided)
  • Active Comparator: CI-581b + Medication Management
    Administration of CI-581b during weeks 1 and 6 at 0.0125 mg/kg in the context of a 12 wk outpatient treatment (no MET/MBRP sessions will be provided, only general check-ins and psychiatrist visits)

Primary Outcome Measure

Daily occurrence of Heavy Drinking Days (HDD) [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYSPINew YorkNew York10032
H.O.P.E. Clinic
888-497-8427
Elias Dakwar, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
NYSPI· New York, NY

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