Suspended

Sublingual Buprenorphine for Chronic Pain and Opioid Dependence Management

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Study Aim

This study aims to evaluate the effectiveness of sublingual Buprenorphine in managing chronic pain and opioid dependence, ensuring no withdrawal symptoms after a 3-day treatment and maintaining a pain-free condition throughout the study duration.

What is being tested

Buprenorphine/Naloxone

Drug
Who is being recruted

Narcotic-Related Disorders+7

+ Mental Disorders

+ Neurologic Manifestations

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorTheresa Jacob, PhD, MPH
Last updated: May 8, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

The study will utilize sublingual buprenorphine for the treatment of chronic pain patients with co-occurring opioid dependence. Adult male and female chronic pain patients with co-occurring opioid dependence/disorder, being treated at MMC will be enrolled in a home induction procedure. Subjects will be switched from their current opioid pain medication to buprenorphine/naloxone to assess whether buprenorphine is at least as effective, if not more effective, as other opioid medications in controlling their pain while simultaneously improving their psychological distress, functional status, and other aspects of patients' lives. We will utilize a home induction procedure, and maintain subjects on this oral medication for a duration of 6 months.

NCT01841931
Principal SponsorTheresa Jacob, PhD, MPH
Last updated: May 8, 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

4 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.

Over 18 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 DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersOpioid-Related DisordersPainChronic Pain

Criteria

3 inclusion criteria required to participate
Has opioid dependence as assessed by a Maimonides psychiatrist
Has received opioid therapy for at least 90 days
Meets DSM criteria for opioid dependence (or opioid use disorder when DSM 5 is in use)
6 exclusion criteria prevent from participating
Lacks sufficient fluency in English to understand the study protocol, answer survey questions or give informed consent
Plan to cease habitation in greater New York area within 6 months
Predicted life expectancy < 1 year
Pregnant women
Show More Criteria

Study Plan

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

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Sublingual buprenorphine/naloxone taken in a 3-day induction, with a final daily dose (up to 32 mg depending on the subject) taken daily, as prescribed by the study psychiatrist. Subjects will continue buprenorphine for study duration (6 months).

Study Objectives

Primary Objectives

Secondary 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

Maimonides Medical Center

Brooklyn, United StatesOpen Maimonides Medical Center in Google Maps
SuspendedOne Study Center