Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00988962
First received: September 30, 2009
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

Chronic back pain patients are often dismissed from a pain center or a primary care practice when they are noncompliant with opioid therapy, instead of being offered treatments to reduce misuse and to improve compliance. Unfortunately, there are few treatment resources for such patients. This study seeks to remedy that problem, with the goal of reducing the rate of prescription opioid misuse among noncompliant patients through the use of novel tracking, education, and counseling interventions.


Condition Intervention
Substance Abuse
Behavioral: cognitive behavioral training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Drug Misuse Index: 1) physician ratings of misuse (ABC), 2) structured self-report interview (PDUQ), and 3) urine tox screens [ Time Frame: All subjects will be followed for 6 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings [ Time Frame: Subjects will be followed for 6 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: July 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: High-Risk No Treatment
Experimental: High-Risk Treatment Behavioral: cognitive behavioral training
electronic diaries, compliance checklists, urine screens, individual and group motivational counseling
Other Names:
  • compliance contract
  • therapy
No Intervention: Low-Risk

Detailed Description:

This study will evaluate drug misuse behavior over 6 months with the use of self-report questionnaires, physician ratings, urine toxicology screens, and electronic diary data.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic pain for >6 months
  • history of taking daily opioids for pain for >6 months
  • average >3 on a pain intensity scale of 0 to 10 over past week
  • able to speak and understand English
  • chronic neck or back pain as primary pain complaint
  • willingness to participate

Exclusion Criteria:

  • current opioid addiction (M.I.N.I. Section K)
  • current diagnosis of cancer or any other malignant disease
  • acute osteomyelitis or acute bone disease
  • nonambulatory
  • present or past DSM-IV diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder
  • pregnancy
  • any clinically unstable systemic illness judged to interfere with treatment
  • an acute condition requiring surgery
  • taking opioids intermittently
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988962

Locations
United States, Massachusetts
Brigham and Women's Hospital Pain Management Center
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Robert N Jamison, PhD Brigham and Women's Hospital
  More Information

Publications:

Responsible Party: Robert N. Jamison, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00988962     History of Changes
Other Study ID Numbers: 2007p001732
Study First Received: September 30, 2009
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
pain
opioids

Additional relevant MeSH terms:
Chronic Pain
Substance-Related Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014