NCT00265265

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2016

Enrollment Period

1.1 years

First QC Date

December 13, 2005

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related Disorders

Keywords

Cocaine Dependence

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Cardiovascular responses

Secondary Outcomes (5)

  • Cocaine craving

  • pharmacokinetic assessment

  • Psychological Effects of Cocaine

  • Abuse Liability

  • Mood and personality assessments

Interventions

AtomoxetineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- please contact the site directly for more information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniformed Services University of Health Science

Bethesda, Maryland, 20814 4799, United States

Location

Related 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.

    PMID: 22987022RESULT

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Louis Cantilena, M.D.

    Uniformed Services University of Health Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 14, 2005

Study Start

August 1, 2005

Primary Completion

September 1, 2006

Last Updated

January 12, 2017

Record last verified: 2016-08

Locations

US(1)