Infusion Laboratory: Protocol 1 - Selegeline - 2 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

November 3, 2005

Start Date ^ICMJE

November 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000337 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Infusion Laboratory: Protocol 1 - Selegeline - 2

Official Title ^ICMJE

Infusion Laboratory: Protocol 1 - Selegeline

Brief Summary

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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Selegiline

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

31 Years to 47 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000337

Responsible Party

Study ID Numbers ^ICMJE

NIDA-3-0010-2, Y01-3-0010-2

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

August 1996

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP