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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Janssen, LP
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00385801
First received: October 6, 2006
Last updated: May 3, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Cocaine Dependence
Drug: Risperidal-Consta
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of the Effects of Risperdal Consta on Brain Reward Circuitry, Craving and Cocaine Use in Active Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • functional MRI activation patterns in the nucleus accumbens and amygdala in response to cocaine cues

Secondary Outcome Measures:
  • cocaine craving scales
  • cocaine use by quantitative urine samples
  • amygdala volume by MRI

Study Start Date: September 2005
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385801

Locations
United States, Massachusetts
MGH Addiction Research Program
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Janssen, LP
Investigators
Principal Investigator: Eden A Evins, MD MPH Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tsafrir Loebl, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00385801     History of Changes
Other Study ID Numbers: RIS-EMR-4021
Study First Received: October 6, 2006
Last Updated: May 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
cocaine
dependence
risperidal
MRI

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Risperidone
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Dopamine Antagonists

ClinicalTrials.gov processed this record on June 17, 2013