Buprenorphine and Naloxone Combination Study - 10

National Institute on Drug Abuse (NIDA)

Overview

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

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

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Heroin Dependence Opioid-Related Disorders

Interventions

Buprenorphine/naloxoneDRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

New York MDRU

New York, New York, United States

Outcomes

Primary Outcomes

Physiological measures

Measurements of buprenorphine and naloxone in plasma

Subjective symptoms measures

Data from ClinicalTrials.gov

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