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:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00385801
First received: October 6, 2006
Last updated: November 6, 2013
Last verified: November 2013

October 6, 2006
November 6, 2013
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 ] [ Designated as safety issue: No ]
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 scales [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • cocaine use by quantitative urine samples [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • amygdala volume by MRI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 MRI, behavioral tests and measuring cocaine craving and use among people with active cocaine dependence.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Cocaine Dependence
Drug: Risperidone
  • Placebo Comparator: sugar pill
    placebo
  • Active Comparator: risperidone consta
    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
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00385801
RIS-EMR-4021
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
November 2013

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