The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence

Cocaine Dependence Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01535937
• Other study ID #: #6403/7339R
• Secondary ID: 1K23DA031771-01
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 2012
• Est. completion date: April 2017

Study information

• Verified date: April 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Ketamine
0.5 mg/kg IV over 40 minutes
• Midazolam
0.025 mg/kg IV over 40 minutes

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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