Study Stopped
An analysis demonstrated that running the final participants was unnecessary.
The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence
2 other identifiers
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedResults Posted
Study results publicly available
September 14, 2018
CompletedMay 1, 2019
April 1, 2019
4.9 years
December 29, 2011
April 12, 2018
April 16, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Cocaine Use/Drop Out
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.
Over the four week period following discharge from the inpatient unit at Day 5
Abstinence
Abstinence is defined as 2 or greater weeks of no cocaine use, as ascertained by the TLFB and urine toxicology.
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
Study Arms (2)
Ketamine
EXPERIMENTAL0.5 mg/kg of ketamine IV over 40 minutes
midazolam
ACTIVE COMPARATOR0.025 mg/kg IV over 40 minutes
Interventions
Eligibility Criteria
You may qualify if:
- 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
- years of age
- Capacity to consent and comply with study procedures, including sufficient proficiency in English
- Seeking treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 31230464DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elias Dakwar, MD
- Organization
- NYSPI
Study Officials
- STUDY CHAIR
Herbert Kleber, M.D.
NYSPI
- PRINCIPAL INVESTIGATOR
Elias Dakwar, MD
New York State Psychiatric Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Psychiatry
Study Record Dates
First Submitted
December 29, 2011
First Posted
February 20, 2012
Study Start
February 1, 2012
Primary Completion
January 1, 2017
Study Completion
April 1, 2017
Last Updated
May 1, 2019
Results First Posted
September 14, 2018
Record last verified: 2019-04