Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

National Institutes of Health (NIH) logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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