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Infusion Laboratory: Protocol 1 - Selegeline - 2

Infusion Laboratory: Protocol 1 - Selegeline

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000337
Enrollment
0
Registered
1999-09-21
Start date
1994-11-30
Completion date
Unknown
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

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.

Interventions

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
31 Years to 47 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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
Degree of drug craving
History, incidence and amount of drug use
Type and severity of stimulant withdrawal symptoms
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026