This trial is active, not recruiting.

Condition cocaine-related disorders
Treatment flupenthixol
Phase phase 1
Sponsor National Institute on Drug Abuse (NIDA)
Trial size 0 participants
Trial identifier NCT00000349, NIDA-3-0010-14, Y01-3-0010-14


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Degree of drug craving
time frame:
History, incidence and amount of drug use
time frame:
Type and severity of stimulant withdrawal symptoms
time frame:
Characterization of study population
time frame:
Population incidence of symptoms of depression, po
time frame:
Frequency and intensity of drug use and sexual beh
time frame:
Evidence of change in neurophysiology and brain ac
time frame:
Evidence of change in subjective responses to coca
time frame:
Clinical physiological response to cocaine challen
time frame:
Degree to which study medication influences change
time frame:

Eligibility Criteria

Male or female participants from 21 years up to 50 years old.

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.

Additional Information

Official title Infusion Laboratory: Protocol 5 (Flupenthixol)
Principal investigator Walter Ling, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2005.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).