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

NCT00385801 | Completed Phase 2 Results

• 1 other identifier: RIS-EMR-4021
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

cocaine; dependence; risperidal; MRI

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Cocaine Craving

  12 weeks

• Amygdala Volume by MRI

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Identical placebo tablets and injections

Drug: Placebo

risperidone consta

ACTIVE COMPARATOR

Risperidone 1-2 mg tablets and Risperidone 25 mg injections

Drug: Risperidone

Interventions

Risperidone DRUG

risperidone consta

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Janssen, LP: collaborator

Study Sites (1)

MGH Addiction Research Program

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Loebl T, Angarita GA, Pachas GN, Huang KL, Lee SH, Nino J, Logvinenko T, Culhane MA, Evins AE. A randomized, double-blind, placebo-controlled trial of long-acting risperidone in cocaine-dependent men. J Clin Psychiatry. 2008 Mar;69(3):480-6. doi: 10.4088/jcp.v69n0321.

  PMID: 18294021 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: A. Eden Evins, MD, MPH. Director of the MGH-Harvard Center for Addiction Medicine
• Organization: Massachusetts General Hospital - Harvard Medical School

a_eden_evins@hms.harvard.edu

6176434679

Study Officials

• Eden A Evins, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: September 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-03

Locations

US (1)