Interactions Between Intravenous (IV) Cocaine and Lofexidine

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Clonidine; Cocaine; Lofexidine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Please contact site for more information