- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00385801
Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence
March 20, 2017 updated by: A. Eden Evins, Massachusetts General Hospital
A Double-Blind, Placebo-Controlled Study of the Effects of Risperdal Consta on Brain Reward Circuitry, Craving and Cocaine Use in Active Cocaine Dependence
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- MGH Addiction Research Program
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Identical placebo tablets and injections
|
|
ACTIVE_COMPARATOR: risperidone consta
Risperidone 1-2 mg tablets and Risperidone 25 mg injections
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues
Time Frame: 12 weeks
|
Measure of Dispersion/Precision not calculated, and raw data are no longer available
|
12 weeks
|
Cocaine Use by Quantitative Urine Samples
Time Frame: 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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cocaine Craving
Time Frame: 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)
|
12 weeks
|
Amygdala Volume by MRI
Time Frame: 12 weeks
|
Measure of Dispersion/Precision not calculated, and raw data are no longer available
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eden A Evins, MD MPH, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
September 1, 2010
Study Registration Dates
First Submitted
October 6, 2006
First Submitted That Met QC Criteria
October 10, 2006
First Posted (ESTIMATE)
October 11, 2006
Study Record Updates
Last Update Posted (ACTUAL)
April 28, 2017
Last Update Submitted That Met QC Criteria
March 20, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- RIS-EMR-4021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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