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Completed

NCT Number: NCT00015288

Buprenorphine and Naloxone Combination Study - 10

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

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Key information

Conditions

Heroin Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New York MDRU

New York, 10010, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

buprenorphine/naloxone

Drug

Primary outcomes

  1. Physiological measures

  2. Measurements of buprenorphine and naloxone in plasma

  3. Subjective symptoms measures

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • New York MDRU

Registry information

Official study title

PK0496 Pharmacokinetics of Buprenorphine

Important dates

Study start
1996
First posted
Apr 18, 2001
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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