Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1

Cocaine-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265265
• Other study ID #: NIDA-CPU-0010-1
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2005
• Last updated: January 11, 2017
• Start date: August 2005

Study information

• Verified date: August 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Atomoxetine

Locations

Country	Name	City	State
United States	Uniformed Services University of Health Science	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cantilena L, Kahn R, Duncan CC, Li SH, Anderson A, Elkashef A. Safety of atomoxetine in combination with intravenous cocaine in cocaine-experienced participants. J Addict Med. 2012 Dec;6(4):265-73. doi: 10.1097/ADM.0b013e31826b767f. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Cardiovascular responses
Secondary	Cocaine craving
Secondary	pharmacokinetic assessment
Secondary	Psychological Effects of Cocaine
Secondary	Abuse Liability
Secondary	Mood and personality assessments