Infusion Laboratory: Protocol 1 - Selegeline - 2
- Conditions
- Cocaine-Related Disorders
- Registration Number
- NCT00000337
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.
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
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Characterization of study population Evidence of change in subjective responses to cocaine challenge Degree of drug craving History, incidence and amount of drug use Clinical physiological response to cocaine challenge - especially adverse effects measures Type and severity of stimulant withdrawal symptoms Degree to which study medication influences changes in #6, 7 & 8 above (possible efficacy measure)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Friends Research Institute
🇺🇸Los Angeles, California, United States