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Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1

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ClinicalTrials.gov Identifier: NCT00067535
Recruitment Status : Completed
First Posted : August 25, 2003
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

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

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Cocaine-Related Disorders Phase 1

Detailed Description:
Phase I, Double-Blind, Placebo-Controlled Dose Escalating Assessment of Potential Interactions Between Intravenous Cocaine and RPR 102681

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Potential Interactions Between IV Cocaine and RPR 102681
Study Start Date : June 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources




Primary Outcome Measures :
  1. Hemodynamic response to cocaine and subjective response to cocaine [ Time Frame: 3x / 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Please contact site for more information.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067535


Locations
United States, Maryland
Uniformed Services University of Health Science
Bethesda, Maryland, United States, 20814 4799
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Louis Cantilena, M.D. Uniformed Services University of Health Science

ClinicalTrials.gov Identifier: NCT00067535     History of Changes
Other Study ID Numbers: NIDA-CPU-0003-1
First Posted: August 25, 2003    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: February 2009

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents