Infusion Laboratory: Protocol 1 - Selegeline - 2

Cocaine-Related Disorders Clinical Trial

Official title:

Infusion Laboratory: Protocol 1 - Selegeline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000337
• Other study ID #: NIDA-3-0010-2
• Secondary ID: Y01-3-0010-2
• Status: Completed
• Phase: Phase 1
• First received: September 20, 1999
• Last updated: January 11, 2017
• Start date: November 1994

Study information

• Verified date: August 1996
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Years to 47 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Selegiline

Locations

Country	Name	City	State
United States	Friends Research Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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