Early Phase II Trials for Cocaine Medication Development - 1

Completed · Phase 2 · Has a placebo group

Conditions studied: Cocaine-Related Disorders, Substance-Related Disorders

In brief

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

Key facts

Study ID

NCT00000317

Run by

New York State Psychiatric Institute

People needed

31

Starts

1996-08-01

Expected to finish

1999-07-01

Last updated by the study team

2017-06-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• NYS Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.