Glutamatergic Modulation of Disordered Alcohol Use
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CI-581a
CI-581b
Motivational Enhancement Therapy (MET)
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence
Eligibility Criteria
Inclusion Criteria:
- Active alcohol dependence. In the case of the use of other drugs, alcohol is designated as the primary drug. At least four heavy drinking day over the past 7 days (>4 drinks a day for males, >3 drinks for females) OR minimum weekly use of 35 drinks for males and 28 for females
- Physically healthy
- No adverse reactions to study medications
- 21-69 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 criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance induced psychosis, and current substance-induced mood disorder.
- Physiological dependence on another substance requiring medical management, such as opiods or benzodiazepines, excluding caffeine, nicotine, and cannabis
- Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders. Significant dissociative symptoms
- Current suicide risk or a history of suicide attempt within the past year
- Inability to safely initiate 24 hours of abstinence from alcohol; repeated inability to initiate abstinence during the trial without incurring significant withdrawal; history of severe withdrawal phenomena over the past 6 months (e.g., withdrawal-related seizure); or self-reported inability to maintain abstinence for 24 hours without substantial distress.
- 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 end-stage AIDS, hypertension (>140/90), leukopenia, active hepatitis or other liver disease with elevated transaminase levels (< 2-3 X upper limit of normal will be considered acceptable if clotting factors are normal), renal failure, epilepsy, or untreated diabetes
- Previous history of study medication misuse or abuse, and a history of an adverse reaction/experience with prior exposure to study medications
- Recent history of significant violence (past 2 years)
- First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
- obesity
- On psychotropic or other medications whose effect could be disrupted by participation in the study
- BMI > 35
Sites / Locations
- NYSPI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CI-581a+MET
CI-581b+MET
Arm Description
Administration of CI-581a during wk 2 at 0.71 mg/kg in the context of a 5 wk course of MET
Administration of CI-581b during wk 2 at 0.025 mg/kg in the context of a 5 wk course of MET
Outcomes
Primary Outcome Measures
Percentage of Participants Demonstrating Alcohol Abstinence in the Control (Midazolam) Group Versus the Active (Ketamine) Group
Percentage of participants demonstrating alcohol abstinence in the control (midazolam) group versus the active (ketamine) group
Secondary Outcome Measures
Full Information
NCT ID
NCT02539511
First Posted
August 21, 2015
Last Updated
January 31, 2020
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT02539511
Brief Title
Glutamatergic Modulation of Disordered Alcohol Use
Official Title
The Effect of Brief Potent Glutamatergic Modulation on Disordered Alcohol Use
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Alcohol use disorders remain a significant public health problem. The pharmacological facilitation of behavioral treatment represents a promising strategy for addressing disordered drinking. Alcohol use disorders are recognized to be associated with various vulnerabilities that complicate the course of treatment and that may be amenable to glutamate modulators. The purpose of this randomized, double-blind, controlled trial is to test various glutamate modulators in conjunction with motivational enhancement therapy (MET) for alcohol use disorders.
Detailed Description
Individuals diagnosed with alcohol dependence will be randomized to receive a single infusion of glutamate modulators during week 2 while engaged in a 5-week course of MET. They will meet with staff twice weekly, except for week 2 during which they will present to the clinic three times. Clinic visits include MET sessions, psychiatric monitoring, assessments, and study procedures (e.g., medication administration).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CI-581a+MET
Arm Type
Experimental
Arm Description
Administration of CI-581a during wk 2 at 0.71 mg/kg in the context of a 5 wk course of MET
Arm Title
CI-581b+MET
Arm Type
Active Comparator
Arm Description
Administration of CI-581b during wk 2 at 0.025 mg/kg in the context of a 5 wk course of MET
Intervention Type
Drug
Intervention Name(s)
CI-581a
Intervention Type
Drug
Intervention Name(s)
CI-581b
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy (MET)
Primary Outcome Measure Information:
Title
Percentage of Participants Demonstrating Alcohol Abstinence in the Control (Midazolam) Group Versus the Active (Ketamine) Group
Description
Percentage of participants demonstrating alcohol abstinence in the control (midazolam) group versus the active (ketamine) group
Time Frame
21 days post-infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active alcohol dependence. In the case of the use of other drugs, alcohol is designated as the primary drug. At least four heavy drinking day over the past 7 days (>4 drinks a day for males, >3 drinks for females) OR minimum weekly use of 35 drinks for males and 28 for females
Physically healthy
No adverse reactions to study medications
21-69 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 criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance induced psychosis, and current substance-induced mood disorder.
Physiological dependence on another substance requiring medical management, such as opiods or benzodiazepines, excluding caffeine, nicotine, and cannabis
Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders. Significant dissociative symptoms
Current suicide risk or a history of suicide attempt within the past year
Inability to safely initiate 24 hours of abstinence from alcohol; repeated inability to initiate abstinence during the trial without incurring significant withdrawal; history of severe withdrawal phenomena over the past 6 months (e.g., withdrawal-related seizure); or self-reported inability to maintain abstinence for 24 hours without substantial distress.
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 end-stage AIDS, hypertension (>140/90), leukopenia, active hepatitis or other liver disease with elevated transaminase levels (< 2-3 X upper limit of normal will be considered acceptable if clotting factors are normal), renal failure, epilepsy, or untreated diabetes
Previous history of study medication misuse or abuse, and a history of an adverse reaction/experience with prior exposure to study medications
Recent history of significant violence (past 2 years)
First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
obesity
On psychotropic or other medications whose effect could be disrupted by participation in the study
BMI > 35
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
31786934
Citation
Dakwar E, Levin F, Hart CL, Basaraba C, Choi J, Pavlicova M, Nunes EV. A Single Ketamine Infusion Combined With Motivational Enhancement Therapy for Alcohol Use Disorder: A Randomized Midazolam-Controlled Pilot Trial. Am J Psychiatry. 2020 Feb 1;177(2):125-133. doi: 10.1176/appi.ajp.2019.19070684. Epub 2019 Dec 2.
Results Reference
derived
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Glutamatergic Modulation of Disordered Alcohol Use
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