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Published on: April 14, 2016
Patient-Centered Prescription Opioid Tapering Methods : A Randomized Clinical Trial
Beth D Darnall1, Luzmercy Perez2, Ming-Chih Kao3
1Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, and Stanford Pain Relief Innovations Lab, Palo Alto, California (B.D.D.).
Background:
Evidence is needed on tapering long-term prescription opioids in outpatient settings.
Objective:
To determine and compare the effectiveness of 3 opioid tapering and pain control strategies (July 2018 to November 2023).
Design:
Randomized controlled trial. (ClinicalTrials.gov: NCT03445988).
Setting:
11 U.S. sites.
Participants:
Adults with pain for at least 6 months receiving a morphine equivalent daily dose (MEDD) of 10 or higher for at least 3 months without moderate or severe opioid use disorder.
Intervention:
Patient-centered opioid tapering with close monitoring and electronic supports was administered as taper only, taper plus cognitive behavioral therapy for chronic pain (pain-CBT), or taper plus a chronic pain self-management program (CPSMP).
Measurements:
Taper success (primary outcome) was either an MEDD decrease of at least 50% with no increased pain or no MEDD increase with decreased pain intensity.
Results:
A total of 562 participants were randomly assigned (191 taper only, 203 taper plus pain-CBT, 168 taper plus CPSMP). The taper success rate was 50.9% (95% CI, 42.9% to 58.9%) for taper only, 48.6% (CI, 41.0% to 56.2%) for taper plus pain-CBT, and 44.5% (CI, 36.0% to 53.3%) for taper plus CPSMP. Tapering with pain-CBT or CPSMP provided no benefit in taper success over taper only (taper plus pain-CBT vs. taper only, -2.4 percentage points [CI, -11.9 to 7.2 percentage points]; taper plus CPSMP vs. taper only, -5.2 percentage points [CI, -15.3 to 4.8 percentage points]). Study-related adverse event risk (including opioid withdrawal symptoms) was highest in the taper only group (126 of 191 [66%]) compared with taper plus pain-CBT (109 of 203 [54%]) and taper plus CPSMP (108 of 168 [64%]).
Limitation:
Challenges related to COVID-19 reduced the sample size and made treatment groups imbalanced; low behavioral treatment attendance and losses to follow-up could have limited effectiveness.
Conclusion:
Adding CBT or self-management to patient-centered opioid tapering did not improve taper success at 12 months, although CBT may reduce adverse effects (including opioid withdrawal symptoms).
Primary Funding Source:
Patient-Centered Outcomes Research Institute.
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