NCT00067535

Brief Summary

The purpose of this study is to assess Potential Interactions Between iv Cocaine and RPR 102681

Trial Health

87
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

Timeline
Completed

Started Jun 2003

Typical duration 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

June 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

January 12, 2017

Status Verified

February 1, 2009

Enrollment Period

1.6 years

First QC Date

August 21, 2003

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic response to cocaine and subjective response to cocaine

    3x / 30 days

Interventions

Cocaine-Related DisordersDRUG

Eligibility Criteria

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

You may qualify if:

  • Includes but is not limited to:
  • Non-treatment seekers
  • DSM-IV criteria for cocaine abuse or dependence
  • Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements

You may not qualify if:

  • Please contact site 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

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 21, 2003

First Posted

August 25, 2003

Study Start

June 1, 2003

Primary Completion

January 1, 2005

Study Completion

June 1, 2005

Last Updated

January 12, 2017

Record last verified: 2009-02

Locations

US(1)