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
  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: Risperidone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
placebo
Active Comparator: risperidone consta Drug: Risperidone

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: A. Eden Evins, PI, 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: November 6, 2013
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
Chemically-Induced Disorders
Mental Disorders
Cocaine
Risperidone
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Dopamine Antagonists

ClinicalTrials.gov processed this record on August 28, 2014