Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2013-06-30
2016-06-30
Brief Summary
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The project will yield information essential to planning a future, larger-scale RCT designed to evaluate: 1) the efficacy of the intervention in preventing prescription opioid abuse, misuse, overdose and other adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain, 2) the effects of the intervention on opioid use, pain, pain related activity interference, and mood. Participants in our pilot study will be limited to those without current opioid abuse or other substance abuse, but past substance abuse will be allowed. This will provide a sample of patients at risk for opioid abuse, misuse and overdose, but who may be able to taper their opioids successfully. Hypothesis: Patients receiving chronic opioid therapy for chronic non-cancer pain who are randomized to the opioid taper support intervention, as compared with patients randomized to usual opioid prescribing care, will have lower opioid average daily doses at 22 and 34 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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taper support
Weekly visits with pharmacological and psychological support for opioid taper at 10% of original dose per week
opioid taper support
Weekly visits with physician's assistant (supervised by pain physician/psychiatrist and pain psychologist) who provides pharmacological and psychological support for opioid taper at 10% per week
Usual care
Usual care for chronic pain. All care allowed except buprenorphine.
No interventions assigned to this group
Interventions
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opioid taper support
Weekly visits with physician's assistant (supervised by pain physician/psychiatrist and pain psychologist) who provides pharmacological and psychological support for opioid taper at 10% per week
Eligibility Criteria
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Inclusion Criteria
* CNCP, defined as pain on more than half the days in the past six months, where indicated diagnostic workup is complete and treatment is focused on pain;
* currently on COT, defined as self-report of prescribed oral opioid medication use on a daily or near-daily (\>90% of days) basis for 90 days or more;
* mean daily opioid dose in the past 30 days of 25 mg MED or greater;
* willing to participate in the study arm to which they are randomly assigned (including opioid taper in-person sessions if randomized to that group);
* able to read, speak, and write English.
Exclusion Criteria
* medical comorbidity with life expectancy less than a year (based on medical record review by the PI);
* recent use (past month) of parenteral, transdermal, or transmucosal opioids,
* currently residing in nursing home;
* currently using intrathecal pump for pain control;
* any current substance abuse according to the DSM-IV checklist (nicotine and marijuana will be allowed since Washington State allows medical marijuana for pain control);
* presence of illicit drug metabolite in baseline urine drug test,
* psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year;
* current suicidal ideation with specific plan or intent;
* significant cognitive impairment (on 6-item screener Scale).
18 Years
80 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Washington
OTHER
Responsible Party
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Mark Sullivan
Prinicipal Study Investigator
Locations
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University of Washington Center for Pain Relief
Seattle, Washington, United States
Countries
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Other Identifiers
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43641-B
Identifier Type: -
Identifier Source: org_study_id
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