Interactions Between Intravenous (IV) Cocaine and Lofexidine

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Cocaine Related Disorders

In brief

The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.

Key facts

Study ID

NCT01148992

Run by

National Institute on Drug Abuse (NIDA)

People needed

16

Starts

2010-08-01

Expected to finish

2011-03-01

Last updated by the study team

2017-01-11

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study.
• Be between 18 and 50 years of age, inclusive.
• Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period.
• Be able to verbalize understanding of the consent form and provide written informed consent.
• Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control:
• diaphragm and condom by partner
• intrauterine device (that does not contain progesterone) and condom by partner
• sponge and condom by partner
• complete abstinence from sexual intercourse
• Note: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed.

You may not qualify if…

• Please contact site for more information

Where it is running

• California Pacific Medical Center Research Institute — San Francisco, California, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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