Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Opioid-Related Disorders

Treatments: Drug: Buprenorphine formulation: liquid vs. tablet

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000320

NIDA-10068-1

R01-10068-1

Details and patient eligibility

About

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."

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

1; liquid formulation

Active Comparator group

Description:

liquid formulation

Treatment:

Drug: Buprenorphine formulation: liquid vs. tablet

2; tablet formulation

Active Comparator group

Description:

tablet formulation

Treatment:

Drug: Buprenorphine formulation: liquid vs. tablet