Skip to content

Evaluation of Liquid vs. Tablet Buprenorphine - 6

Pharmacokinetics and Bioavailability of Liquid vs Tablet Buprenorphine

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000341
Enrollment
1
Registered
1999-09-21
Start date
1996-08-31
Completion date
2000-08-31
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-Related Disorders

Keywords

opioid dependence

Brief summary

The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.

Interventions

DRUGBuprenorphine

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

M/F ages 21-50. Meet DSM-IV criteria for opioid dependence. Agree to conditions of the study and sign informed consent.

Exclusion criteria

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Design outcomes

Primary

MeasureTime frame
Subjective and observer rater physiological effects of bup

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026