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
Recruitment status was Active, not recruiting
Sponsor:
Massachusetts General Hospital
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
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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