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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.
Janssen, LP
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital Identifier:
First received: October 6, 2006
Last updated: November 6, 2013
Last verified: November 2013
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: Risperidone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
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 [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • cocaine craving scales [ Time Frame: 12 weeks ]
  • cocaine use by quantitative urine samples [ Time Frame: 12 weeks ]
  • amygdala volume by MRI [ Time Frame: 12 weeks ]

Enrollment: 31
Study Start Date: September 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: sugar pill
Active Comparator: risperidone consta Drug: Risperidone


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00385801

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: A. Eden Evins, PI, Massachusetts General Hospital Identifier: NCT00385801     History of Changes
Other Study ID Numbers: RIS-EMR-4021
Study First Received: October 6, 2006
Last Updated: November 6, 2013

Keywords provided by Massachusetts General Hospital:

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators processed this record on April 26, 2017