Search / Trial NCT00000317

Early Phase II Trials for Cocaine Medication Development - 1

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

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Cocaine Methadone Patients Risperidone

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 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:
  • good standing at methadone maintenance program
  • DSM-IV criteria for cocaine dependence or abuse
  • used cocaine at least 4 times in last month
  • able to give informed consent
  • Exclusion criteria
  • currently meets DSM-IV criteria for Major depression or dysthymia
  • meets DSM-IV criteria for attention deficit hyperactivity disorder, bipolar disorder, schizophrenia or any psychotic disorder
  • history of seizures
  • history of allergic reaction to risperidone
  • chronic organic mental disorder
  • significant current suicidal risk
  • pregnancy, lactation or failure to use adequate birth control (for females)
  • unstable physical disorders that may make participation hazardous
  • coronary vascular disease
  • cardiac conduction system disease as indicated by QRS duration >/= 0.11
  • current use of other prescribed psychotropic medications
  • history of failure to respond to a previous adequate trial of risperidone
  • history of neuroleptic malignant syndrome, tardive dyskinesia, or severe extrapyramidal reactions to neuroleptic medications
  • current DSM-IV criteria for another substance dependence other than nicotine.

Attachments

readout_NCT00000317_2024-06-14.pdf

4.5 MB

NCT00000317_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

1x/week for 18 weeks

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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