Completed

Comparison of Liquid and Tablet Buprenorphine Formulations in Steady-State Pharmacokinetics

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What is being tested

Data Collection

Who is being recruted

Narcotic-Related Disorders+3

+ Mental Disorders

+ Heroin Dependence

From 21 to 50 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

Summary

Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

This study focuses on comparing two forms of buprenorphine, a medication used for treatment, in liquid and tablet form. The research involves individuals who are inducted on either the liquid or tablet version, without knowing which one they are receiving. The goal is to understand the effects of these different forms once they reach a steady state, typically by the second week. This study is crucial as it aims to improve treatment methods and address current challenges associated with buprenorphine use. During the study, participants are scheduled for blood draws in specific weeks. The main outcomes being measured are drug craving, drug use, and retention, which refers to how well the medication stays in the body. These measurements help evaluate the effectiveness and safety of both forms of buprenorphine, potentially aiding in the development of improved treatment strategies.

Official TitleExpanded Steady-State Pharmacokinetic Study, Comparing Liquid and Tablet Buprenorphine Formulations
NCT00000302
Principal SponsorNational Institute on Drug Abuse (NIDA)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Narcotic-Related DisordersMental DisordersHeroin DependenceOpioid-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Criteria

4 inclusion criteria required to participate
M/F ages 21-50.

Opiate dependence according to DSM-IV criteria.

Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine.

Agreeable to conditions of study and signed informed consent.

6 exclusion criteria prevent from participating
Psychiatric disorder that requires medication therapy.

History of seizures.

Pregnant and/or nursing women.

Dependence on ETOH or benzodiazepines or other sedative-hypnotics.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Friends Research Institute

Los Angeles, United StatesOpen Friends Research Institute in Google Maps
CompletedOne Study Center