NIDA-CPU-0010

Division
HEAL Study
Title
Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine
Short Description
This is a human laboratory clinical pharmacology study to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (Strattera) administered orally in four escalating doses.
Release Date
Jun 03, 2020
Description

This is a dose escalating, double-blind, placebo-controlled inpatient study in 16 cocaine-experienced volunteers. The subjects will receive atomoxetine 20 mg once daily (q.d.) for 2 days, 40 mg q.d. for 2 days, 80 mg q.d. for 5 days and 100 mg q.d. for 5 days orally or matched placebo. After beginning daily treatment with either atomoxetine or placebo, subjects will receive treatment cocaine infusions of 20 mg and 40 mg i.v. on the two last days of 80 mg and 100 mg atomoxetine dosage levels. Each cocaine infusion will be preceded or followed by saline i.v. infusion in random order; cocaine and saline infusions will be administered 60 minutes apart. The subjects will be discharged 4 days after the last infusion of cocaine (day 17). Subjects will be requested to return for follow-up 2 weeks after the day of discharge.

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Study Data
Study Links
Study Documents
Case Report Form(s)
Deidentification Notes