Status:
TERMINATED
Interactions Between Intravenous (IV) Cocaine and Lofexidine
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Related Disorders
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.
Detailed Description
To determine the safety of daily oral lofexidine alone and concurrent with IV cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.
Eligibility Criteria
Inclusion
- 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
- Please contact site for more information
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01148992
Start Date
August 1 2010
End Date
March 1 2011
Last Update
January 11 2017
Active Locations (2)
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1
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94110
2
Baylor College of Medicine
Houston, Texas, United States, 77030