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Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03344419
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Elias Dakwar, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE November 13, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
Abstinence from Cocaine Use [ Time Frame: from baseline to week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
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 to Facilitate the Behavioral Treatment of Cocaine Use Disorders
Official Title  ICMJE Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
Brief Summary Changes in the communication of glutamate from one brain structure to another are important in the development of therapy for cocaine use disorders. Our preliminary investigations suggest that drugs that affect glutamate exchange may be effective at promoting and maintaining individuals' abstinence from cocaine. The purpose of this randomized, double-blind, controlled trial is to test various glutamate modulators in conjunction with motivational enhancement therapy (MET) and mindfulness based relapse prevention (MBRP) for cocaine use disorders.
Detailed Description

Alterations in the transmission between neurons of a neurotransmitter called glutamate are an important target of pharmacotherapy for cocaine use disorders (CUDs). Preliminary investigations suggest that glutamate modulation may be effective at promoting and maintaining abstinence and that it promotes motivation to quit, reduces craving, reduces cocaine self-administration and facilitates abstinence in individuals with a CUD in a series of trials.

The study team has recently developed and tested a novel design that integrates a clinical trial involving serial infusions and a behavioral treatment platform. The current trial will evaluate the effect of two sub-anesthetic infusions on abstinence rates in a relatively large sample of treatment-seeking CUD individuals who complete a 12-week double-blind, randomized, controlled trial. It will also evaluate the correlation between clinical response and brain-derived neurotrophic factor (BDNF), a peripheral biomarker relevant to glutamate modulation antidepressant response. This project aims to expand on several years of promising preliminary data to rigorously evaluate the efficacy of this innovative pharmacological intervention integrated into a behavioral treatment platform.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cocaine Use Disorder
Intervention  ICMJE
  • Drug: CI-581a
    Medication infusion intravenously over 1 hour.
  • Drug: CI-581b
    Medication infusion intravenously over 1 hour.
  • Behavioral: Motivational Enhancement Therapy (MET)
    Manualized one on one therapy aimed at mobilizing motivation for change and for goals.
  • Behavioral: Mindfulness Based Relapse Prevention
    Manualized one on one therapy aimed at mindfulness-based behavioral modification and the cultivation of relapse prevention skils.
Study Arms  ICMJE
  • Experimental: CI-581a+MET+MBRP
    Administration of CI-581a at 0.71 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP
    Interventions:
    • Drug: CI-581a
    • Behavioral: Motivational Enhancement Therapy (MET)
    • Behavioral: Mindfulness Based Relapse Prevention
  • Active Comparator: CI-581b+MET+MBRP
    Administration of CI-581b at 0.025 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP
    Interventions:
    • Drug: CI-581b
    • Behavioral: Motivational Enhancement Therapy (MET)
    • Behavioral: Mindfulness Based Relapse Prevention
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Meets DSM-V criteria for cocaine use disorders, with at least 1 day of use per week over the past 30 days
  2. Physically healthy
  3. No adverse reactions to study medications
  4. 21-69 years of age (including a score > 24 on the Mental Mini Status Exam for individuals over 60 years of age)
  5. Capacity to consent and comply with study procedures
  6. Seeking Treatment

Exclusion Criteria:

  1. Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance induced psychosis, and current substance-induced mood disorder with HAMD score > 12.
  2. Physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine and nicotine
  3. Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
  4. Current suicide risk or a history of suicide attempt within the 2 years
  5. Pregnant, interested in becoming pregnant, or lactating
  6. On psychotropic or other medication whose effect could be disrupted by participation in the study, such as benzodiazepines, opioids, or barbiturates
  7. Recent history of significant violence (past 2 years)
  8. Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
  9. Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), anemia, active hepatitis or other liver disease (transaminase levels < 2-3 X the upper limit of normal will be considered acceptable), or untreated diabetes
  10. Previous history of ketamine or benzodiazepine abuse, and/or a history of adverse reaction/experience with prior exposure to ketamine or benzodiazepines
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elias Dakwar, MD 646-774-6117 elias.dakwar@nyspi.columbia.edu
Contact: Ryan Fox ryan.fox@nyspi.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03344419
Other Study ID Numbers  ICMJE 7461
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elias Dakwar, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE Not Provided
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