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

Phase 2

Completed

Conditions: Cocaine Dependence

Interventions: Drug: Risperidone
Drug: Placebo

Registration Number: NCT00385801

Lead Sponsor: Massachusetts General Hospital

Brief Summary: The purpose of this study is to examine the effects of the administration of Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI), behavioral tests and measuring cocaine craving and use among people with active cocaine dependence.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 31

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
risperidone consta	Risperidone	Risperidone 1-2 mg tablets and Risperidone 25 mg injections
Placebo	Placebo	Identical placebo tablets and injections

Primary Outcome Measures

Name	Time	Method
Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues	12 weeks	Measure of Dispersion/Precision not calculated, and raw data are no longer available
Cocaine Use by Quantitative Urine Samples	12 weeks	After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below

Secondary Outcome Measures

Name	Time	Method
Amygdala Volume by MRI	12 weeks	Measure of Dispersion/Precision not calculated, and raw data are no longer available
Cocaine Craving	12 weeks	The University of Minnesota Cocaine Craving Scale was performed to assess cocaine craving. The scale contains 1 continuous scale for intensity and 2 categorical scales for frequency and duration of craving episodes. The continuous scale for craving intensity ranges from 0 (no craving at all in the past week) to 10 (a great deal of craving in the past week)