Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

January 5, 2009

Start Date ^ICMJE

October 1997

Primary Completion Date

August 1999 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

blood level [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Craving
Drug use
Withdrawal symptoms

Change History

Complete list of historical versions of study NCT00000320 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

drug use [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]
craving [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]
withdrawal symptoms [ Time Frame: across study duration ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

Official Title ^ICMJE

Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution

Brief Summary

The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."

Detailed Description

1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacokinetics Study

Condition ^ICMJE

Opioid-Related Disorders

Intervention ^ICMJE

Drug: Buprenorphine formulation: liquid vs. tablet

Study Arms / Comparison Groups

Active Comparator: liquid formulation
Active Comparator: tablet formulation

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

August 1999

Primary Completion Date

August 1999 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000320

Responsible Party

Walter Ling, M.D., Friends Research Institute

Study ID Numbers ^ICMJE

NIDA-10068-1, R01-10068-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP