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

Condition	Treatment or Intervention	Phase
Heroin Dependence Opioid-Related Disorders	Drug: Buprenorphine/naloxone	Phase I

Further Study Details: 

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

Ages Eligible for Study:  21 Years   -   50 Years,  Genders Eligible for Study:  Both

Criteria

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.

New York
      New York MDRU, New York,  New York,  10010,  United States

Study chairs or principal investigators

John Rotrosen, M.D.,  Principal Investigator,  New York MDRU   

Study ID Numbers:  NIDA-5-0013-10; Y01-5-0013-10
Record last reviewed:  August 1998
Last Updated:  December 3, 2004
Record first received:  April 18, 2001
ClinicalTrials.gov Identifier:  NCT00015288
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08