Phase 2
Completed N=31
Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence
Cocaine Dependence
Source: ClinicalTrials.gov NCT00385801 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues |
— | — |
| PRIMARY Cocaine Use by Quantitative Urine Samples |
1.81; 0.87 | — |
| SECONDARY Cocaine Craving |
NA; NA | 0.86 |
| SECONDARY Amygdala Volume by MRI |
— | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00385801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.