Infusion Laboratory: Protocol 4 (Dihydrexidine) - 13

Cocaine-Related Disorders Clinical Trial

Official title:

Infusion Laboratory: Protocol 4 (Dihydrexidine)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00000348
• Other study ID #: NIDA-3-0010-13
• Secondary ID: Y01-3-0010-13
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 20, 1999
• Last updated: January 10, 2017

Study information

• Verified date: December 2002
• 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• 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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Dihydrexidine

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, 

Outcome

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