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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

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.

Condition or disease Intervention/treatment Phase
Cocaine Use Disorder Drug: CI-581a Drug: CI-581b Behavioral: Motivational Enhancement Therapy (MET) Behavioral: Mindfulness Based Relapse Prevention Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: CI-581a
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.

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
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.




Primary Outcome Measures :
  1. Abstinence from Cocaine Use [ Time Frame: from baseline to week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03344419


Contacts
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Contact: Elias Dakwar, MD 646-774-6117 elias.dakwar@nyspi.columbia.edu
Contact: Ryan Fox ryan.fox@nyspi.columbia.edu

Locations
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United States, New York
STARS Recruiting
New York, New York, United States, 10019
Contact: Elias Dakwar, MD    646-774-6117    elias.dakwar@nyspi.columbia.edu   
Contact: Ryan Fox       ryan.fox@nyspi.columbia.edu   
NYSPI Recruiting
New York, New York, United States, 10032
Contact: Elias Dakwar, MD    646-774-6117    elias.dakwar@nyspi.columbia.edu   
Principal Investigator: Elias Dakwar, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)

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Responsible Party: Elias Dakwar, research psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03344419    
Other Study ID Numbers: 7461
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elias Dakwar, New York State Psychiatric Institute:
cocaine
mindfulness based relapse prevention
motivational enhancement therapy
Additional relevant MeSH terms:
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Disease
Pathologic Processes
Cocaine
Ketamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents