The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking

Overview

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 (2×2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment.

Full Title of Study: “The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking: a Randomized, Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2023

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).

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • Daily occurrence of Heavy Drinking Days (HDD)
    • Time Frame: 12 weeks
    • Defined as >4 drinks/day for men; >3 drinks for women. Comparing this outcome between groups that receive CI-581a versus CI-581b, as well as between CI-581a groups.

Secondary Measures

  • Daily occurrence of drinking days
    • Time Frame: 12 weeks
    • Comparing this outcome in between group that received CI-581a versus CI-581b, as well as between CI-581a groups.

Participating in This Clinical Trial

Inclusion Criteria

1. Active alcohol use disorder, with at least 4 heavy drinking day over the past 7 days (greater than 4 drinks a day for males, greater than 3 drinks for females). In the case of the use of other drugs, alcohol is designated as the primary drug.

2. Physically healthy

3. No adverse reactions to study medications

4. 21-70 years of age

5. Capacity to consent and comply with study procedures, including sufficient proficiency in English

6. Seeking to reduce or stop alcohol use

Exclusion Criteria

1. Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, or any psychotic illness, including substance induced psychosis

2. Physiological dependence on another substance, such as opioids or benzodiazepines, excluding caffeine, nicotine, and cannabis

3. Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders

4. Current suicide risk or a history of suicide attempt within the past year

5. Inability to safely initiate 24 hours of abstinence from alcohol, as evidenced by CIWA greater than 10 during screening; history of severe withdrawal phenomena over the past 6 months (e.g., inpatient stabilization, withdrawal-related seizure); or self-reported inability to maintain abstinence for 24 hours.

6. Pregnant or interested in becoming pregnant during the study period

7. Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse

8. Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (greater than 160/90), WBC less than 3.5, active hepatitis or other liver disease with elevated transaminase levels (less than 2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), renal failure (creat greater than 2, BUN greater than 40), epilepsy, or untreated diabetes

9. Previous history of misuse or abuse of study medications, and a history of an adverse reaction/experience with prior exposure to study medications

10. On psychotropic or other medications whose effect could be disrupted by participation in the study

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • New York State Psychiatric Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elias Dakwar, Assistant Professor of Clinical Psychiatry – Columbia University
  • Overall Official(s)
    • Elias Dakwar, MD, Principal Investigator, NYSPI/Columbia
  • Overall Contact(s)
    • Kate O’Malley, 6467746103, kate.omalley@columbia.edu

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