The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg
0mg
California Pacific Medical Center Research Institute
San Francisco, California, United States
Baylor College of Medicine
Houston, Texas, United States
Adverse Event and Cardiovascular Response
Adverse Events will measured during follow-up at weeks 14-21
Time frame: Daily, up to 9 days
Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)
Time frame: Daily, up to 9 days
PK of Lofexidine
Time frame: Daily, up to 9 days
Visual Analog Scale (VAS)
Time frame: Daily, up to 9 days
Brief Substance Abuse Craving Scale (BSCA)
Time frame: Daily, up to 9 days
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