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Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00385801
First Posted: October 11, 2006
Last Update Posted: April 28, 2017
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. Read our disclaimer for details.
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital
October 6, 2006
October 11, 2006
April 30, 2015
April 28, 2017
April 28, 2017
September 2005
September 2010   (Final data collection date for primary outcome measure)
  • Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues [ Time Frame: 12 weeks ]
    Measure of Dispersion/Precision not calculated, and raw data are no longer available
  • Cocaine Use by Quantitative Urine Samples [ Time Frame: 12 weeks ]
    After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below
Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues
Complete list of historical versions of study NCT00385801 on ClinicalTrials.gov Archive Site
  • Cocaine Craving [ Time Frame: 12 weeks ]
    The University of Minnesota Cocaine Craving Scale was performed to assess cocaine craving. The scale contains 1 continuous scale for intensity and 2 categorical scales for frequency and duration of craving episodes. The continuous scale for craving intensity ranges from 0 (no craving at all in the past week) to 10 (a great deal of craving in the past week)
  • Amygdala Volume by MRI [ Time Frame: 12 weeks ]
    Measure of Dispersion/Precision not calculated, and raw data are no longer available
  • cocaine craving scales
  • cocaine use by quantitative urine samples
  • Amygdala Volume by MRI
Not Provided
Not Provided
 
Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence
A Double-Blind, Placebo-Controlled Study of the Effects of Risperdal Consta on Brain Reward Circuitry, Craving and Cocaine Use in Active Cocaine Dependence
The purpose of this study is to examine the effects of the administration of Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI), behavioral tests and measuring cocaine craving and use among people with active cocaine dependence.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Cocaine Dependence
  • Drug: Risperidone
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Identical placebo tablets and injections
    Intervention: Drug: Placebo
  • Active Comparator: risperidone consta
    Risperidone 1-2 mg tablets and Risperidone 25 mg injections
    Intervention: Drug: Risperidone
Loebl T, Angarita GA, Pachas GN, Huang KL, Lee SH, Nino J, Logvinenko T, Culhane MA, Evins AE. A randomized, double-blind, placebo-controlled trial of long-acting risperidone in cocaine-dependent men. J Clin Psychiatry. 2008 Mar;69(3):480-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • current cocaine dependence who use cocaine at least every 2 weeks
  • Non-treatment seekers who intend to continue using cocaine
  • Male 18-60 years of age
  • Potential participants must be literate in the English language, and be able to understand and complete rating scales and questionnaires accurately
  • Able to provide informed consent
  • Potential participants must be able to identify at least one "locator" person to assist in tracking the participant for follow-up assessments

Exclusion Criteria:

  • Other current substance dependence requiring immediate detoxification
  • Diagnosis of schizophrenia, bipolar disorder, current major depressive disorder
  • Currently suicidal or at high risk for suicide in the judgment of the investigator
  • Carrying a medical device incompatible with MRI (e.g., metal implants such as surgical clips or pacemakers and extensive dental work such as bridges) or suffering from significant claustrophobia that would make MRI unfeasible.
  • Size incompatible with MRI procedures
  • Serious medical illness including HIV-1 infection
  • Hepatitis C + titer with liver enzymes more than 2x normal or a Mini-Mental Status Exam Score of <25/30
  • Insulin dependent diabetes mellitus (IDDM) or non- insulin dependent diabetes mellitus (NIDDM) and abnormal Hemoglobin A1C
  • Severe hepatic or renal impairment
  • History of seizure disorder, delirium, dementia, or mental disorders due to general medical conditions
  • History of head trauma or stroke with lasting neurological sequelae
  • Tardive dyskinesia, extrapyramidal movement disorder, Parkinson's Disease or history of Neuroleptic Malignant Syndrome
  • Clinical or laboratory evidence of uncontrolled hypothyroidism/hyperthyroidism
  • Orthostatic hypotension, defined as a decrease of at > 10 mm Hg in systolic blood pressure and/or an increase in heart rate of > 20 beats per minute, measured one minute following transition from a supine to a standing position.
  • History of allergy or hypersensitivity to Risperidone
  • Treatment with: Neuroleptics, Antidepressants, Antiarrhythmics, Carbamazepine, Phenytoin, Valproate, Rifampin, Phenobarbital, Levodopa and other dopamine agonists, Fluoxetine, Interferon, Propylthiouracil, Methimazole, Opiates.
  • Treatment within 30 days prior to screening with an investigational drug or medication with the potential to influence cocaine use outcomes
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00385801
RIS-EMR-4021
Not Provided
Not Provided
Not Provided
A. Eden Evins, Massachusetts General Hospital
Massachusetts General Hospital
Janssen, LP
Principal Investigator: Eden A Evins, MD MPH Massachusetts General Hospital
Massachusetts General Hospital
March 2017

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