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OpenTrials
Completed

NCT Number: NCT00988962

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

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.

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Key information

Conditions

Substance Abuse Chemically-Induced Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital Pain Management Center

Chestnut Hill, Massachusetts, 02467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive behavioral training

Behavioral

electronic diaries, compliance checklists, urine screens, individual and group motivational counseling

Other names: compliance contract, therapy

Primary outcomes

  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 outcomes

  1. 1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings

    Time frame: Subjects will be followed for 6 months.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 2, 2009
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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