Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

Opiate Addiction Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879996
• Other study ID #: FMD0350908A
• Secondary ID: K23AA015616R03DA
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2009
• Last updated: August 3, 2012
• Start date: April 2009
• Est. completion date: October 2011

Study information

• Verified date: August 2012
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.

Description:

The purpose of this randomized clinical trial is to compare methadone with buprenorphine for the treatment of chronic pain among patients who have developed a physical dependence on prescription opiate analgesics that is associated with psychosocial dysfunction (i.e., addiction).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• chronic back pain

• opioid addiction

• not successful with abstinence

• at least 18 years old

• able to understand spoken English

• live in Western New York State (Erie or Niagara county)

• have health insurance or ability to pay for health care

• no methadone or buprenorphine treatment within past year

• not member of a vulnerable population (e.g., pregnancy, prisoner)

Exclusion Criteria:

• homelessness

• unable to give consent (e.g., dementia, psychosis)

• serious heart or lung disease

• taking a medication that could interact with methadone or buprenorphine

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Opiate Addiction

Intervention

Drug:
• Methadone
Oral, 10-60 mg per day, 2-4 times per day, 6 months
• Buprenorphine/naloxone
Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months

Locations

Country	Name	City	State
United States	Erie County Medical Center	Buffalo	New York
United States	Sheehan Memorial Hospital	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Retained in Treatment	This outcome assesses the number of participants who completed the treatment after 6 months.	6 months	No
Secondary	Numerical Rating Score for Pain	Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.	6 months	No
Secondary	Numerical Rating Score for Functioning	We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning.	6 months	No
Secondary	Self-reported Illicit Opioid Use		6 months	No