Buprenorphine and Naloxone Combination Study - 10

Phase 1

Completed

• Conditions: Heroin Dependence; Opioid-Related Disorders

• Registration Number: NCT00015288
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

The purpose of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Detailed Description

The objective of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Study Timeline

• Study Start: 1996-11
• Status Verified: 1998-08
• Study First Submitted QC: 2001-04-17
• Study First Submitted: 2001-04-18
• Study First Posted: 2001-04-18
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male/Female between the ages of 21 and 45. Within 15% of ideal body weight. No oral pathology that would interfere with the sublingual absorption of the medication. Experienced in the use of opiates but not dependent.

Exclusion Criteria

LFT's exceeding than 3x's normal. History of seizure. Opiate dependent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurements of buprenorphine and naloxone in plasma
Physiological measures
Subjective symptoms measures

Trial Locations

Locations (1)

New York MDRU; 🇺🇸 New York, New York, United States