The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence

Ketamine

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.

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Midazolam

Condition or Disease

  • Cocaine Dependence

Phase

Study Design

Study type: Interventional
Status: Terminated
Study results: Has Results
Age: 21 Years to 60 Years   (Adult)
Enrollment: 55 ()
Funded by: Other|NIH

Masking

Clinical Trial Dates

Start date: Feb 12, 2020
Primary Completion: Jan 17, 2020
Completion Date: Apr 17, 2020
Study First Posted: Feb 20, 2012
Results First Posted: Sep 14, 2018
Last Updated: May 01, 2019

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

New York, New York, USA

The 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.

Eligibility Criteria

Sex: All
Minimum Age: 21
Maximum Age: 60

More Details

NCT Number: NCT01535937
Other IDs: #6403/7339R|1K23DA031771-01
Study URL: https://ClinicalTrials.gov/show/NCT01535937
Last updated: Feb 22, 2021