Chronic Non-cancer Pain Clinical Trial
Official title:
Pilot Randomized Trial of Opioid Taper Support
The proposed research will develop, demonstrate the feasibility of, and pilot test in a
randomized controlled trial a prescription opioid taper support intervention. This
intervention aims to prevent opioid misuse and adverse events among patients receiving
chronic opioid therapy for chronic non-cancer pain without evidence of current substance
abuse.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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