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Infusion Laboratory: Protocol 1 - Selegeline - 2

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000337
First Posted: September 21, 1999
Last Update Posted: January 12, 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 determine the effects of selegiline on the subjective and physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.

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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Infusion Laboratory: Protocol 1 - Selegeline

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Degree of drug craving
  • History, incidence and amount of drug use
  • Type and severity of stimulant withdrawal symptoms
  • Population incidence of symptoms of depression, possible organic brain syndrome deficits
  • Frequency and intensity of drug use and sexual behaviors at risk for HIV
  • Evidence of change in neurophysiology and brain activity
  • Evidence of change in subjective responses to cocaine challenge
  • Clinical physiological response to cocaine challenge - especially adverse effects measures
  • Degree to which study medication influences changes in #6, 7 & 8 above (possible efficacy measure)
  • Characterization of study population

Estimated Enrollment: 0
Study Start Date: November 1994
Detailed Description:
To develop a medication for the treatment of cocaine addiction using a medical human physio-neuro-psycho-immunology laboratory setting. To characterize this cocaine abusing population on a variety of psychological and physicologically measures over time from withdrawal through pere and post cocaine administration. To determine the effects of selegeline on the subjective and physiological effects of cocaine challenge in chronic crack abusers. To evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years to 47 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): NCT00000337


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

Publications:
1996 CPDD: "Acute cocaine administration reverses EEG signs of cocaine withdrawal.". 1996 CPDD: "Acute cocaine administration reverses EEG signs of cocaine withdrawal."

ClinicalTrials.gov Identifier: NCT00000337     History of Changes
Other Study ID Numbers: NIDA-3-0010-2
Y01-3-0010-2
First Submitted: September 20, 1999
First Posted: September 21, 1999
Last Update Posted: January 12, 2017
Last Verified: August 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