Sublingual Buprenorphine for Chronic Pain

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: buprenorphine

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Beth Israel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

1. 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
2. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: A

Drug: buprenorphine; 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.; Other Names: Suboxone®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain severity	1, 2, 3, 4, 5 & 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain behaviors, psychiatric distress, drug use, side effects	Months 1 through 6

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborators: Beth Israel Medical Center
• Investigators: Principal Investigator: Andrew Rosenblum, PhD, NDRI

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): May 1, 2009
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: February 6, 2008
• First Submitted That Met QC Criteria: February 6, 2008
• First Posted (Estimate): February 11, 2008

Study Record Updates

• Last Update Posted (Estimate): April 7, 2009
• Last Update Submitted That Met QC Criteria: April 6, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Pain; Chronic pain; Buprenorphine; Drug addiction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: R21DA022675 (U.S. NIH Grant/Contract)