Interactions Between Intravenous (IV) Cocaine and Lofexidine
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal