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Infusion Laboratory: Protocol 3 (Risperidone) - 4

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 1996 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000339
First Posted: September 21, 1999
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
The purpose of this study is to evaluate clinical safety issues pertaining to risperidone, to cocaine and to its interaction, and to determine how pretreatment with risperidone modifies the subjective as well as physiological effects of cocaine.

Condition Intervention Phase
Cocaine-Related Disorders Drug: Risperidone Phase 1

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Infusion Laboratory: Protocol 3 (Risperidone)

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Evidence of change in neurotoxicity based on chore
  • Degree of drug craving
  • History, incidence and amount of drug use
  • Type and severity of stimulant withdrawal symptoms
  • Characterization of study population
  • Population incidence of symptoms of depression, po
  • Frequency and intensity of drug use and sexual beh
  • Evidence of change in subjective responses to coca
  • Clinical physiological response to cocaine challen
  • Degree to which study medication influences change

Estimated Enrollment: 13
Study Start Date: June 1996
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000339


Locations
United States, California
Friends Research Institute
Los Angeles, California, United States, 90025
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Walter Ling, M.D. Friends Research Institute, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00000339     History of Changes
Other Study ID Numbers: NIDA-3-0010-4
Y01-3-0010-4
First Submitted: September 20, 1999
First Posted: September 21, 1999
Last Update Posted: January 11, 2017
Last Verified: June 1996

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents