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CompletedNCT00015288Updated Jan 12, 2017

Buprenorphine and Naloxone Combination Study - 10

A Phase 1 interventional study of Buprenorphine/naloxone in Heroin Dependence and Opioid-Related Disorders, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-01-12.

Sponsored by National Institute on Drug Abuse (NIDA) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Ages
21 Years to 50 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Heroin Dependence
  • Opioid-Related Disorders
03

In context

Heroin Dependence

90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.

Browse Heroin Dependence studies →

Lead sponsor

National Institute on Drug Abuse (NIDA) is the lead sponsor of 393 studies on the registry; 19 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
Double
Enrollment
0 participants

Interventions

06

What researchers measure

Primary outcomes

  1. Physiological measures

  2. Measurements of buprenorphine and naloxone in plasma

  3. Subjective symptoms measures

07

Study locations

1 site
  • New York MDRU
    New York, New York 10010, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00015288
Collaborators
New York MDRU
First posted
Apr 18, 2001
Start date
Nov 1996
Last update
Jan 12, 2017

Study contacts

John Rotrosen, M.D.
principal investigator · New York MDRU
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 1998. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Buprenorphine · Naloxone

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