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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00000349
Other study ID # NIDA-3-0010-14
Secondary ID Y01-3-0010-14
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 clinical safety issues pertaining to flupenthixol, to cocaine, and to their interaction, and to determine how pretreatment with flupenthixol modifies the subjective as well as physiological effects of cocaine. Taken together, these relatively D-1 selective agents can help determine the extent to which DA-1 binding affects the reinforcing effects of stimulants.


Recruitment information / eligibility

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Flupenthixol


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 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 Frequency and intensity of drug use and sexual beh
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
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