Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers - 1

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Unknown status
• CT.gov ID: NCT00032916
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The purpose of this study is to conduct a drug interaction study with NS2359 and cocaine in cocaine experienced volunteers.

Condition or Disease	Intervention/Treatment	Phase
Cocaine-Related Disorders; Drug Administration Schedule; Infusions, Intravenous	Drug: NS2359	Phase 1

Detailed Description

This is a single-center, double-blind, placebo-controlled, randomized, single dose, fixed order, dose escalating inpatient design that will study oral NS2359 in cocaine experienced volunteers.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers
• Study Start Date: Jun 1, 2001
• Study Completion Date: Dec 1, 2002

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic parameter comparison []

2. plasma concentration []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Male or Female, 18-45 yrs of age; females of child-bearing potential using appropriate method of birth control; be able to understand the procedure and agrees to participate via informed consent; must be cocaine dependent according to DSM-4 criteria; must be capable of providing written consent; must be able to comply with protocol requirement, CPU rules and regulations; must not be currently seeking treatment for cocaine abuse.

Exclusion Criteria:

Incapable of understanding the informed consent process; Additional criteria available during screening at the site.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00032916
• Other Study ID Numbers: NIDA-CPU-2359-02-1; NCT00031330
• First Posted: Apr 8, 2002
• Last Update Posted: Jan 11, 2017
• Last Verified: Apr 1, 2004

• Additional relevant MeSH terms: Cocaine-Related Disorders

Study Results

No Results Posted as of Jan 11, 2017