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

Not Applicable

Completed

• Conditions: Substance Abuse
• Interventions: Behavioral: cognitive behavioral training

• Registration Number: NCT00988962
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-Risk Treatment	cognitive behavioral training	-

Primary Outcome Measures

Name	Time	Method
Drug Misuse Index: 1) physician ratings of misuse (ABC), 2) structured self-report interview (PDUQ), and 3) urine tox screens	All subjects will be followed for 6 months.

Secondary Outcome Measures

Name	Time	Method
1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings	Subjects will be followed for 6 months.

Trial Locations

Locations (1)

Brigham and Women's Hospital Pain Management Center; 🇺🇸 Chestnut Hill, Massachusetts, United States