Search / Trial NCT00000317

Early Phase II Trials for Cocaine Medication Development - 1

Launched by NEW YORK STATE PSYCHIATRIC INSTITUTE · Sep 20, 1999

Trial Information

Current as of December 05, 2024

Completed

Keywords

Cocaine Methadone Patients Risperidone

ClinConnect Summary

This was an 18-week prospective, randomized, placebo-controlled crossover design with placebo lead-in phase and terminal placebo phase. After two weeks of single-blind placebo, patients were randomly assigned to one of two schedules of medication:

2 Week Baseline Weeks 1-6 Weeks 7-12 Weeks 13-18 Group 1 placebo risperidone placebo placebo Group 2 placebo placebo risperidone placebo

The first 6-week phase provided an initial double-blind medication-placebo comparison. In the second six-week phase (weeks 7-12), patients crossed over to the opposite treatment. During weeks 13-18, Group 1 pat...

Gender

ALL

Eligibility 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.

Trial Officials

Edward Nunes, M.D.

Principal Investigator

NYS Psychiatric Institute

About New York State Psychiatric Institute

The New York State Psychiatric Institute (NYSPI) is a leading research organization dedicated to advancing the understanding and treatment of mental health disorders. Affiliated with Columbia University, NYSPI integrates clinical research with cutting-edge scientific inquiry to develop innovative therapeutic strategies and improve patient care. With a focus on a wide range of psychiatric conditions, NYSPI conducts clinical trials that aim to translate findings from laboratory research into effective interventions, enhancing the quality of life for individuals affected by mental illness. Committed to ethical research practices and collaboration, NYSPI plays a pivotal role in shaping the future of psychiatric care through rigorous scientific exploration and community engagement.

Locations

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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