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

Condition(s) targeted: Cocaine Dependence

Intervention: Risperidone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Eden A Evins, MD MPH, Principal Investigator, Affiliation: Massachusetts General Hospital

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.

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

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

Primary outcome: functional MRI activation patterns in the nucleus accumbens and amygdala in response to cocaine cues

Secondary outcome:

cocaine craving scales

cocaine use by quantitative urine samples

amygdala volume by MRI

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Male.

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

MGH Addiction Research Program, Boston, Massachusetts 02114, United States

Starting date: September 2005
Last updated: November 6, 2013