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Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1

Phase 1, Double-Blind, Placebo-Controlled Multiple Dose Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00265265
Enrollment
16
Registered
2005-12-14
Start date
2005-08-31
Completion date
Unknown
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine-Related Disorders

Keywords

Cocaine Dependence

Brief summary

The purpose of this study is to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (Strattera) administered orally in four escalating doses.

Interventions

DRUGAtomoxetine

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 18-45 years of age who are not seeking treatment at the time of the study * Must be able to provide written informed consent * Must be within 20 percent of ideal body weight and weigh at least 45 kg * Must meet DSM0IV diagnostic criteria for cocaine abuse or dependence * Must currently be using cocaine as confirmed by a positive BE * If female and of child bearing potential, must agree to the use of birth control

Exclusion criteria

\- please contact the site directly for more information

Design outcomes

Primary

MeasureTime frame
Safety
Cardiovascular responses

Secondary

MeasureTime frame
Cocaine craving
Abuse Liability
Psychological Effects of Cocaine
pharmacokinetic assessment
Mood and personality assessments

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026