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Glutamatergic Modulation of Disordered Alcohol Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02539511
Recruitment Status : Completed
First Posted : September 3, 2015
Results First Posted : April 23, 2019
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Elias Dakwar, Columbia University

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: CI-581a Drug: CI-581b Behavioral: Motivational Enhancement Therapy (MET) Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Brief Potent Glutamatergic Modulation on Disordered Alcohol Use
Study Start Date : July 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: CI-581a+MET
Administration of CI-581a during wk 2 at 0.71 mg/kg in the context of a 5 wk course of MET
Drug: CI-581a
Behavioral: Motivational Enhancement Therapy (MET)
Active Comparator: CI-581b+MET
Administration of CI-581b during wk 2 at 0.025 mg/kg in the context of a 5 wk course of MET
Drug: CI-581b
Behavioral: Motivational Enhancement Therapy (MET)



Primary Outcome Measures :
  1. Percentage of Participants Demonstrating Alcohol Abstinence in the Control (Midazolam) Group Versus the Active (Ketamine) Group [ Time Frame: 21 days post-infusion ]
    Percentage of participants demonstrating alcohol abstinence in the control (midazolam) group versus the active (ketamine) group



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539511


Locations
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United States, New York
NYSPI
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Elias Dakwar, MD NYSPI/Columbia
  Study Documents (Full-Text)

Documents provided by Elias Dakwar, Columbia University:
Study Protocol  [PDF] September 5, 2017
Statistical Analysis Plan  [PDF] September 5, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elias Dakwar, Assistant Professor of Clinical Psychiatry, Columbia University
ClinicalTrials.gov Identifier: NCT02539511    
Other Study ID Numbers: 7014
R21AA023010 ( U.S. NIH Grant/Contract )
First Posted: September 3, 2015    Key Record Dates
Results First Posted: April 23, 2019
Last Update Posted: February 11, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action