Suspended

Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence

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What is being tested

Data Collection

Who is being recruted

Narcotic-Related Disorders+2

+ Mental Disorders

+ Opioid-Related Disorders

From 18 to 55 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2002
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

Study start date: September 1, 2002

Actual date on which the first participant was enrolled.

Buprenorphine is a mixed agonist-antagonist opioid that is being developed as a treatment for opioid dependence. Because buprenorphine is a partial mu agonist opioid, under certain conditions it is possible for buprenorphine to precipitate opioid withdrawal in opioid dependent individuals. A person with a high level of physical dependence could experience buprenorphine-related precipitated withdrawal. The purpose of this study is to test the acute effects of different doses of buprenorphine/naloxone in opioid dependent individuals maintained on methadone. The study is designed to provide dosing schedules similar to those that might be initially used in a physician's office.

Official TitleTransitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence
NCT00000243
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.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

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 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

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

Conditions

Pathology

Narcotic-Related DisordersMental DisordersOpioid-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Criteria

1 inclusion criteria required to participate
Meets criteria for opioid dependence
1 exclusion criteria prevent from participating
Significant medical or psychiatric illness

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

Johns Hopkins University (BPRU) Bayview Campus

Baltimore, United StatesOpen Johns Hopkins University (BPRU) Bayview Campus in Google Maps
SuspendedOne Study Center
Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence | PatLynk