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Completed

NCT Number: NCT00000337

Infusion Laboratory: Protocol 1 - Selegeline - 2

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.

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

31 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Friends Research Institute

Los Angeles, California, 90025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selegiline

Drug

Primary outcomes

  1. Degree of drug craving

  2. History, incidence and amount of drug use

  3. Type and severity of stimulant withdrawal symptoms

  4. Population incidence of symptoms of depression, possible organic brain syndrome deficits

  5. Frequency and intensity of drug use and sexual behaviors at risk for HIV

  6. Evidence of change in neurophysiology and brain activity

  7. Evidence of change in subjective responses to cocaine challenge

  8. Clinical physiological response to cocaine challenge - especially adverse effects measures

  9. Degree to which study medication influences changes in #6, 7 & 8 above (possible efficacy measure)

  10. Characterization of study population

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Infusion Laboratory: Protocol 1 - Selegeline

Important dates

Study start
1994
First posted
Sep 21, 1999
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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