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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00988962
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : June 27, 2011
National Institutes of Health (NIH)
Information provided by:
Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Substance Abuse Behavioral: cognitive behavioral training Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy
Study Start Date : July 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings [ Time Frame: Subjects will be followed for 6 months. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00988962

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
National Institutes of Health (NIH)
Principal Investigator: Robert N Jamison, PhD Brigham and Women's Hospital


Responsible Party: Robert N. Jamison, PhD, Brigham and Women's Hospital Identifier: NCT00988962     History of Changes
Other Study ID Numbers: 2007p001732
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Brigham and Women's Hospital:

Additional relevant MeSH terms:
Chronic Pain
Substance-Related Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents