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Completed

NCT Number: NCT00000320

Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

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."

Completed

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Friends Research Institute

Los Angeles, California, 90025, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Buprenorphine formulation: liquid vs. tablet

Drug

random assignment to liquid buprenorphine or tablet buprenorphine

Other names: Subutex, Suboxone

Primary outcomes

  1. blood level

    Time frame: across study duration

Secondary outcomes

  1. drug use

    Time frame: across study duration

  2. craving

    Time frame: across study duration

  3. withdrawal symptoms

    Time frame: across study duration

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution

Important dates

Study start
1997
Primary completion
1999
Study completion
1999
First posted
Sep 21, 1999
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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