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The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CI-581a
CI-581b
MBRP
MET
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 hypertension (>160/90), anemia, active hepatitis or other liver disease (transaminase levels < 2-3 X the upper limit of normal will be considered acceptable), epilepsy, or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that study medications in combination with this medication may increase the risk of drug-induced hepatitis.
  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. Recent history of significant violance
  11. On psychotropic or other medications whose effect could be disrupted by participation in the study

Sites / Locations

  • NYSPIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

CI-581a + MET/MBRP

CI-581a + Medication Management

CI-581b + MET/MBRP

CI-581b + Medication Management

Arm Description

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)

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)

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)

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)

Outcomes

Primary Outcome Measures

Daily occurrence of Heavy Drinking Days (HDD)
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 Outcome Measures

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

Full Information

First Posted
September 4, 2019
Last Updated
March 31, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04084860
Brief Title
The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking
Official Title
The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2019 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Alterations in glutamate neurotransmission are an important target of pharmacotherapy for alcohol use disorder. Our investigations with glutamate modulators in drug and alcohol dependent individuals suggest that they may exert unique therapeutic effects on dependence-related vulnerabilities and may also address problem drinking in alcohol dependent individuals. The proposed project will expand on our prior research by testing the efficacy of glutamate modulators in a larger population of non-depressed individuals with alcohol use disorder (AUD); 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. It, therefore, has the potential to deepen our understanding of the therapeutic role of glutamate modulators in AUD treatment, as well as to provide further evidence for the efficacy of this novel pharmacotherapy strategy in addressing problem use

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CI-581a + MET/MBRP
Arm Type
Experimental
Arm Description
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)
Arm Title
CI-581a + Medication Management
Arm Type
Experimental
Arm Description
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)
Arm Title
CI-581b + MET/MBRP
Arm Type
Active Comparator
Arm Description
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)
Arm Title
CI-581b + Medication Management
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
CI-581a
Intervention Description
CI-581a during weeks 1 and 6 at 0.71 mg/kg
Intervention Type
Drug
Intervention Name(s)
CI-581b
Intervention Description
CI-581b during weeks 1 and 6 at 0.0125 mg/kg
Intervention Type
Behavioral
Intervention Name(s)
MBRP
Other Intervention Name(s)
Mindfulness Based Relapse Prevention (MBRP)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
MET
Other Intervention Name(s)
Motivational Enhancement Therapy (MET)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Daily occurrence of Heavy Drinking Days (HDD)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Daily occurrence of drinking days
Description
Comparing this outcome in between group that received CI-581a versus CI-581b, as well as between CI-581a groups.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Physically healthy No adverse reactions to study medications 21-70 years of age Capacity to consent and comply with study procedures, including sufficient proficiency in English Seeking to reduce or stop alcohol use Exclusion Criteria: Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, or any psychotic illness, including substance-induced psychosis Physiological dependence on another substance, such as opioids or benzodiazepines, excluding caffeine, nicotine, and cannabis Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders Current suicide risk or a history of suicide attempt within the past year 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. Pregnant or interested in becoming pregnant during the study period Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse Unstable physical disorders which might make participation hazardous such as hypertension (>160/90), anemia, active hepatitis or other liver disease (transaminase levels < 2-3 X the upper limit of normal will be considered acceptable), epilepsy, or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that study medications in combination with this medication may increase the risk of drug-induced hepatitis. Previous history of misuse or abuse of study medications, and a history of an adverse reaction/experience with prior exposure to study medications Recent history of significant violance On psychotropic or other medications whose effect could be disrupted by participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate O'Malley
Phone
6467746103
Ext
6103
Email
kate.omalley@nyspi.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elias Dakwar, MD
Phone
6467748728
Ext
8728
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias Dakwar, MD
Organizational Affiliation
NYSPI/Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYSPI
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H.O.P.E. Clinic
Phone
888-497-8427
First Name & Middle Initial & Last Name & Degree
Elias Dakwar, MD

12. IPD Sharing Statement

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The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking

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