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

Cocaine Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385801
• Other study ID #: RIS-EMR-4021
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2006
• Last updated: November 6, 2013
• Start date: September 2005
• Est. completion date: September 2010

Study information

• Verified date: November 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Risperidone

Locations

Country	Name	City	State
United States	MGH Addiction Research Program	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Janssen, LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional MRI activation patterns in the nucleus accumbens and amygdala in response to cocaine cues		12 weeks	No
Secondary	cocaine craving scales		12 weeks	No
Secondary	cocaine use by quantitative urine samples		12 weeks	No
Secondary	amygdala volume by MRI		12 weeks	No