Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

National Institute on Drug Abuse (NIDA)120 enrolled

Overview

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."

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine formulation: liquid vs. tabletDRUG

random assignment to liquid buprenorphine or tablet buprenorphine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Friends Research Institute

Los Angeles, California, United States

Outcomes

Primary Outcomes

blood level

Time frame: across study duration

Secondary Outcomes

drug use

Time frame: across study duration

craving

Time frame: across study duration

withdrawal symptoms

Time frame: across study duration

Data from ClinicalTrials.gov

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