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Sublingual Buprenorphine for Chronic Pain

Primary Purpose

Chronic Pain

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

buprenorphine

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Pain, Chronic pain, Buprenorphine, Drug addiction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Undergoing treatment for moderate-severe chronic pain for at least six months at either an ambulatory practice of the Department of Pain and Palliative Medicine Beth Israel Medical Center in New York City or the the Peter Kruger Clinic at the same institution.

Either

On opioid therapy (any dose) and observed to have had at least four of the aberrant drug-related behaviors described in (Passik et al. Clin J Pain; 22(2):173-81 2006) during the past six months, or
Considered a candidate for long-term therapy by the pain specialist and a history of a substance use disorder, as determined by DSM-IV criteria, but no longer meeting criteria for at least one year.

Age 18-70

Exclusion Criteria:

Meets DSM-IV criteria for current opioid dependence or other substance use disorder including alcohol abuse.
Currently being treated for opioid dependence with methadone.
Currently maintained on naltrexone (e.g., for alcohol dependence).
Taking benzodiazepines on a daily basis.
A history of moderate-severe cardiopulmonary disease or symptoms or signs consistent with moderate-severe cardiopulmonary disease.
Elevated liver function test (LFT) results (> 2.5 above normal).

Sites / Locations

Beth Israel Medical Center
Beth Israel Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Pain severity

Secondary Outcome Measures

Pain behaviors, psychiatric distress, drug use, side effects

Full Information

NCT ID

NCT00612287

First Posted

February 6, 2008

Last Updated

April 6, 2009

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Beth Israel Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00612287

Brief Title

Sublingual Buprenorphine for Chronic Pain

Official Title

Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2009 (undefined)

Primary Completion Date

May 2009 (Anticipated)

Study Completion Date

August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Beth Israel Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to develop and pilot test clinical guidelines for the use of buprenorphine for the treatment chronic pain among patients with substance abuse histories. Buprenorphine, an opioid medication, holds promise as a treatment of chronic pain because, compared to most other opioid analgesics, it has a high safety profile, a low level of physical dependence, and mild withdrawal symptoms on cessation. Moreover there are promising reports from Europe of its use as a skin patch to treat chronic pain as well as clinical reports in the U.S. that it may be effective when used sublingually (placed under the tongue). This study will test the sublingual formulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

Pain, Chronic pain, Buprenorphine, Drug addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

buprenorphine

Other Intervention Name(s)

Suboxone®

Intervention Description

Sublingual buprenorphine; product name Suboxone® (buprenorphine/naloxone). Dosing is informed by a clinical guideline which permits flexibility dependent up physician's clinical judgment. During the induction period (Day 1, at the physician's office) the first dose is 2 mg and can be brought up to 20 mg depending on patient's response. On Day 2 going forward dose can range from 2 mg q8h to 12 mg q8h. Rescue doses with buprenorphine are also permitted.

Primary Outcome Measure Information:

Title

Pain severity

Time Frame

1, 2, 3, 4, 5 & 6 months

Secondary Outcome Measure Information:

Title

Pain behaviors, psychiatric distress, drug use, side effects

Time Frame

Months 1 through 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Undergoing treatment for moderate-severe chronic pain for at least six months at either an ambulatory practice of the Department of Pain and Palliative Medicine Beth Israel Medical Center in New York City or the the Peter Kruger Clinic at the same institution. Either On opioid therapy (any dose) and observed to have had at least four of the aberrant drug-related behaviors described in (Passik et al. Clin J Pain; 22(2):173-81 2006) during the past six months, or Considered a candidate for long-term therapy by the pain specialist and a history of a substance use disorder, as determined by DSM-IV criteria, but no longer meeting criteria for at least one year. Age 18-70 Exclusion Criteria: Meets DSM-IV criteria for current opioid dependence or other substance use disorder including alcohol abuse. Currently being treated for opioid dependence with methadone. Currently maintained on naltrexone (e.g., for alcohol dependence). Taking benzodiazepines on a daily basis. A history of moderate-severe cardiopulmonary disease or symptoms or signs consistent with moderate-severe cardiopulmonary disease. Elevated liver function test (LFT) results (> 2.5 above normal).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Russell K Portenoy, MD

Phone

212-844-1505

Rportenoy@bethisrael.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Rosenblum, PhD

Organizational Affiliation

NDRI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Russell K Portenoy, MD

Facility Name

Beth Israel Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

12. IPD Sharing Statement

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Sublingual Buprenorphine for Chronic Pain

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