Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1

Cocaine-Related Disorders Clinical Trial

Official title:

Potential Interactions Between IV Cocaine and RPR 102681

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067535
• Other study ID #: NIDA-CPU-0003-1
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2003
• Last updated: January 11, 2017
• Start date: June 2003
• Est. completion date: June 2005

Study information

• Verified date: February 2009
• 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 iv Cocaine and RPR 102681

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Cocaine-Related Disorders

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic response to cocaine and subjective response to cocaine		3x / 30 days	Yes