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Glutamatergic Modulation of Disordered Alcohol Use

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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

Tracking Information
First Submitted Date  ICMJE August 21, 2015
First Posted Date  ICMJE September 3, 2015
Results First Submitted Date  ICMJE January 25, 2019
Results First Posted Date  ICMJE April 23, 2019
Last Update Posted Date February 11, 2020
Study Start Date  ICMJE July 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
change from baseline in number of heavy drinking days ascertained through timeline followback (TLFB) [ Time Frame: from baseline to week 5 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glutamatergic Modulation of Disordered Alcohol Use
Official Title  ICMJE The Effect of Brief Potent Glutamatergic Modulation on Disordered Alcohol Use
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE
  • Drug: CI-581a
  • Drug: CI-581b
  • Behavioral: Motivational Enhancement Therapy (MET)
Study Arms  ICMJE
  • 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
    Interventions:
    • 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
    Interventions:
    • Drug: CI-581b
    • Behavioral: Motivational Enhancement Therapy (MET)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2020)
50
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2015)
40
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02539511
Other Study ID Numbers  ICMJE 7014
R21AA023010 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elias Dakwar, Columbia University
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Elias Dakwar, MD NYSPI/Columbia
PRS Account New York State Psychiatric Institute
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP