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The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT01535937
Recruitment Status : Terminated (An analysis demonstrated that running the final participants was unnecessary.)
First Posted : February 20, 2012
Results First Posted : September 14, 2018
Last Update Posted : May 1, 2019
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 December 29, 2011
First Posted Date  ICMJE February 20, 2012
Results First Submitted Date  ICMJE April 12, 2018
Results First Posted Date  ICMJE September 14, 2018
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE February 2012
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Number of Participants With Cocaine Use/Drop Out [ Time Frame: Over the four week period following discharge from the inpatient unit at Day 5 ]
    Number of participants who use cocaine and drop from study. During phase 2, patients will be assessed twice weekly by TLFB and urine toxicology for cocaine use. The day of first use will determine the length of time that transpired from discharge to the first lapse onto cocaine.
  • Abstinence [ Time Frame: Abstinence will be assessed over 4 weeks starting at the last day of week 1 and continuing through the end of study at the last day of week 5 ]
    Abstinence is defined as 2 or greater weeks of no cocaine use, as ascertained by the TLFB and urine toxicology.
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
Time to first cocaine use [ Time Frame: Over the four week period following discharge from the inpatient unit at Day 5 ]
During phase 2, patients will be assessed twice weekly by TLFB and urine toxicology for cocaine use. The day of first use will determine the length of time that transpired from discharge to the first lapse onto cocaine.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
  • Abstinence Rates [ Time Frame: Abstinence will be assessed over 4 weeks starting at the last day of week 1 and continuing through the end of study at the last day of week 5 ]
    Abstinence is defined as an average two weeks or greater of no cocaine use, as ascertained by TLFB and urine toxicology.
  • Stress and cue reactivity [ Time Frame: This will be assessed over the five week course of the trial; on days 1 and 5, on the last day of week 2, and on the last day of week 5 ]
    Self-assessments as well as endocrine, physiological, and other assessments are used to ascertain stress and cue reactivity as well as craving at the above-mentioned time-points as well as, in some cases, continuously over the five week period of the trial.
  • Mindfulness [ Time Frame: This will be assessed over the five week course of the trial; on days 1 and 5, on the last day of week 2, and on the last day of week 5 ]
    The Five Facet Mindfulness Questionnaire will be administered at various points throughout the study in order to ascertain the effect of the intervention on mindfulness as compared to the control.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence
Official Title  ICMJE Not Provided
Brief Summary This project will evaluate the effect of a single sub-anesthetic dose of ketamine on the time to first cocaine use and abstinence rates in 60 treatment-seeking cocaine-dependent individuals receiving mindfulness-based relapse prevention (MBRP) therapy, using a 5 week combined laboratory-inpatient and outpatient double-blind, randomized, controlled trial.
Detailed Description

he study will begin with an inpatient phase (phase 1) of 5 days, during which abstinence is achieved, followed by a 4 week outpatient phase (phase 2). A single infusion of ketamine or midazolam will occur on day 3 of Phase 1. In addition to measures of mindfulness and impulsivity, stress sensitivity tests are incorporated into the design in order to elucidate mechanisms of action. The study hypotheses are:

  1. ketamine and MBRP will significantly increase the time to first use compared to placebo and MBRP in cocaine-dependent individuals.
  2. ketamine and MBRP is significantly more likely to lead to abstinence from cocaine (no use over one week) as compared to placebo and MBRP.
  3. ketamine and MBRP will significantly reduce subjective, endocrine, and physiological responses to stress (including cue exposure) as compared to placebo and MBRP.
  4. ketamine and MBRP will significantly increase mindfulness, as assessed by the Five Facet Mindfulness Questionnaire (FFMQ), as compared to placebo and MBRP.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cocaine Dependence
Intervention  ICMJE
  • Drug: Ketamine
    0.5 mg/kg IV over 40 minutes
    Other Name: ketamine 0.5 mg/kg
  • Drug: Midazolam
    0.025 mg/kg IV over 40 minutes
    Other Name: midazolam 0.025 mg/kg
Study Arms  ICMJE
  • Experimental: Ketamine
    0.5 mg/kg of ketamine IV over 40 minutes
    Intervention: Drug: Ketamine
  • Active Comparator: midazolam
    0.025 mg/kg IV over 40 minutes
    Intervention: Drug: Midazolam
Publications * Dakwar E, Nunes EV, Hart CL, Foltin RW, Mathew SJ, Carpenter KM, Choi CJJ, Basaraba CN, Pavlicova M, Levin FR. A Single Ketamine Infusion Combined With Mindfulness-Based Behavioral Modification to Treat Cocaine Dependence: A Randomized Clinical Trial. Am J Psychiatry. 2019 Nov 1;176(11):923-930. doi: 10.1176/appi.ajp.2019.18101123. Epub 2019 Jun 24.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: August 7, 2017)
55
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2012)
60
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active cocaine dependence with at least 8 days of use or at least 4 binges of large amounts (>$200/occasion) over the past 30 days, and displaying at least one positive utox during screening
  • Physically healthy
  • No adverse reactions to study medications
  • 21-60 years of age
  • Capacity to consent and comply with study procedures, including sufficient proficiency in English
  • Seeking treatment

Exclusion Criteria:

  • 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.
  • Physiological dependence on another substance requiring medical management, such as alcohol, opioids, or benzodiazepines, excluding caffeine, nicotine, and cannabis
  • Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders
  • Current suicide risk or a history of suicide attempt within the past year
  • Pregnant or interested in becoming pregnant during the study period
  • Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
  • Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), WBC < 3.5, active hepatitis or other liver disease with elevated transaminase levels (< 2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), renal failure (creatinine > 2, BUN >40), or untreated diabetes
  • Previous history of ketamine or benzodiazepine misuse or abuse, and a history of an adverse reaction/experience with prior exposure to ketamine or benzodiazepine
  • Recent history of significant violence (past 2 years)
  • First degree relative with a psychotic disorder (bipolar disorder, schizophrenia, schizoaffective disorder, or psychosis NOS)
  • BMI > 32, or a history of documented obstructive sleep apnea
  • On psychotropic or other medications whose effect could be disrupted by participation in the study
  • Patients who cannot comply with study procedures during the initial hospitalization phase
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (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 NCT01535937
Other Study ID Numbers  ICMJE #6403/7339R
1K23DA031771-01 ( 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, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Study Chair: Herbert Kleber, M.D. NYSPI
Principal Investigator: Elias Dakwar, MD New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date April 2019

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