Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

NCT ID: NCT00000320

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-10-31

Study Completion Date

1999-08-31

Brief Summary

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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

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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

Conditions

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Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1; liquid formulation

liquid formulation

Group Type ACTIVE_COMPARATOR

Buprenorphine formulation: liquid vs. tablet

Intervention Type DRUG

random assignment to liquid buprenorphine or tablet buprenorphine

2; tablet formulation

tablet formulation

Group Type ACTIVE_COMPARATOR

Buprenorphine formulation: liquid vs. tablet

Intervention Type DRUG

random assignment to liquid buprenorphine or tablet buprenorphine

Interventions

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Buprenorphine formulation: liquid vs. tablet

random assignment to liquid buprenorphine or tablet buprenorphine

Intervention Type DRUG

Other Intervention Names

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Subutex Suboxone

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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Friends Research Institute

Principal Investigators

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Walter Ling, M.D.

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

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Friends Research Institute

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01-10068-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-10068-1

Identifier Type: -

Identifier Source: org_study_id

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