Cocaine-Related Disorders Clinical Trial
Official title:
Infusion Laboratory: Protocol 4 (Dihydrexidine)
The purpose of this study is to evaluate safety issues pertaining to dihydrexidine (DHX), to cocaine, and to its interaction, and to determine how pretreatment with DHX modifies the subjective as well as physiological effects of cocaine infusion.
Status | Active, not recruiting |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 50 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. |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Friends Research Institute | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of drug craving | |||
Primary | Frequency of IV drug use and sexual risk behaviors | |||
Primary | History, incidence and amount of drug use | |||
Primary | Type and severity of stimulant withdrawal symptoms | |||
Primary | Characterization of study population | |||
Primary | Population incidence of symptoms of depression, po | |||
Primary | Evidence of change in neurophysiology and brain ac | |||
Primary | Evidence of change in subjective responses to coca | |||
Primary | Clinical physiological response to cocaine challen | |||
Primary | Degree to which study medication influences change |