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.
Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment
Official Title:
Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy
Further study details as provided by Brigham and Women's Hospital:
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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
Estimated Study Completion Date:
June 2011
Estimated Primary Completion Date:
June 2011 (Final data collection date for primary outcome measure)
electronic diaries, compliance checklists, urine screens, individual and group motivational counseling
Low-Risk: No Intervention
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988962
