Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1

NCT ID: NCT00265265

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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

Detailed Description

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Conditions

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Cocaine-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atomoxetine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louis Cantilena, M.D.

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of Health Science

Locations

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Uniformed Services University of Health Science

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22987022 (View on PubMed)

Other Identifiers

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NIDA-CPU-0010-1

Identifier Type: -

Identifier Source: org_study_id

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