Early Phase II Trials for Cocaine Medication Development - 1

• Status: Completed
• Trial end date: 1999-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents.

The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene, Inc.
• Treatments: Cocaine; Risperidone

Criteria

Inclusion:

1. good standing at methadone maintenance program

2. DSM-IV criteria for cocaine dependence or abuse

3. used cocaine at least 4 times in last month

4. able to give informed consent

Exclusion criteria

1. currently meets DSM-IV criteria for Major depression or dysthymia

2. meets DSM-IV criteria for attention deficit hyperactivity disorder, bipolar disorder, schizophrenia or any psychotic disorder

3. history of seizures

4. history of allergic reaction to risperidone

5. chronic organic mental disorder

6. significant current suicidal risk

7. pregnancy, lactation or failure to use adequate birth control (for females)

8. unstable physical disorders that may make participation hazardous

9. coronary vascular disease

10. cardiac conduction system disease as indicated by QRS duration >/= 0.11

11. current use of other prescribed psychotropic medications

12. history of failure to respond to a previous adequate trial of risperidone

13. history of neuroleptic malignant syndrome, tardive dyskinesia, or severe extrapyramidal reactions to neuroleptic medications

14. current DSM-IV criteria for another substance dependence other than nicotine.