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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Placebo-Controlled Study of the Effects of Risperdal Consta on Brain Reward Circuitry, Craving and Cocaine Use in Active Cocaine Dependence

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Risperidone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Identical placebo tablets and injections | Drug: Placebo<br> <br> |
| Active Comparator: risperidone consta<br>Risperidone 1-2 mg tablets and Risperidone 25 mg injections | Drug: Risperidone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues | Measure of Dispersion/Precision not calculated, and raw data are no longer available | 12 weeks | 
| Cocaine Use by Quantitative Urine Samples | 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine Craving | 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) | 12 weeks | 
| Amygdala Volume by MRI | Measure of Dispersion/Precision not calculated, and raw data are no longer available | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine, dependence, risperidal, MRI