Sublingual Buprenorphine for Chronic Pain

NCT00612287 | Unknown Phase 2

• 1 other identifier: R21DA022675
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain

Keywords

Pain; Chronic pain; Buprenorphine; Drug addiction

Outcome Measures

Primary Outcomes (1)

• Pain severity

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

Secondary Outcomes (1)

• Pain behaviors, psychiatric distress, drug use, side effects

  Months 1 through 6

Study Arms (1)

A

EXPERIMENTAL

Drug: buprenorphine

Interventions

buprenorphine DRUG

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.

Also known as: Suboxone®

A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• Beth Israel Medical Center: collaborator

Study Sites (2)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain; Substance-Related Disorders

Interventions

Buprenorphine; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Andrew Rosenblum, PhD

  NDRI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Russell K Portenoy, MD

CONTACT

212-844-1505; Rportenoy@bethisrael.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 11, 2008
• Study Start: April 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 7, 2009

Record last verified: 2009-04

Locations

US (2)