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Infusion Laboratory: Protocol 4 (Dihydrexidine) - 13

Infusion Laboratory: Protocol 4 (Dihydrexidine)

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000348
Enrollment
0
Registered
1999-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2017-01-11

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 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.

Interventions

DRUGDihydrexidine

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 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
Degree of drug craving
Frequency of IV drug use and sexual risk behaviors
History, incidence and amount of drug use
Type and severity of stimulant withdrawal symptoms
Characterization of study population
Population incidence of symptoms of depression, po
Evidence of change in neurophysiology and brain ac
Evidence of change in subjective responses to coca
Clinical physiological response to cocaine challen
Degree to which study medication influences change

Countries

United States

Outcome results

None listed

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