Status:

COMPLETED

Early Phase II Trials for Cocaine Medication Development - 1

Lead Sponsor:

New York State Psychiatric Institute

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

Research Foundation for Mental Hygiene, Inc.

Conditions:

Cocaine-Related Disorders

Substance-Related Disorders

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

Brief 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 tr...

Detailed Description

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 ...

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.

Key Trial Info

Start Date :

August 1 1996

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 1999

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT00000317

Start Date

August 1 1996

End Date

July 1 1999

Last Update

June 26 2017

Active Locations (1)

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1

NYS Psychiatric Institute

New York, New York, United States, 10032

Early Phase II Trials for Cocaine Medication Development - 1 | DecenTrialz