Infusion Laboratory: Protocol 1 - Selegeline - 2 - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000337

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 I

Drug Information available for: Selegiline Selegiline hydrochloride

U.S. FDA Resources

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

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

Ages Eligible for Study:	31 Years to 47 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	NIDA-3-0010-2, Y01-3-0010-2
Study First Received:	September 20, 1999
Last Updated:	November 3, 2005
ClinicalTrials.gov Identifier:	NCT00000337
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Selegiline
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Monoamine Oxidase Inhibitors
Antiparkinson Agents

Enzyme Inhibitors
Central Nervous System Agents
Protective Agents
Neuroprotective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009