Official NIH NLM MEDLINE / PubMed Citation • PMID: 42407075 • DOI: 10.7326/ANNALS-25-04784

Patient-Centered Prescription Opioid Tapering Methods: A Randomized Clinical Trial.

Annals of internal medicine • 2026 Sep • Vol. 179 (9) : 1221-1231 • ISSN 1539-3704

Authors: Beth D Darnall, Luzmercy Perez, Ming-Chih Kao, Kate Lorig, Aram S Mardian, Pamela Flood, Ting Pun, Eric R Hanson, William Brose, Chwen-Yuen A Chen, Matthias Cheung, Luana Colloca, Korina De Bruyne, Naomi Edelson, Eileen Kim, Mark McGovern, Nathaniel Moore, Bruce D Nicholson, Joel Porter, Heather Poupore-King, Vafi Salmasi, Richard L Stieg, Lanja S Sinjary, Jiapeng Xu, Juliette Hong, Lu Tian, Sean C Mackey

Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, and Stanford Pain Relief Innovations Lab, Palo Alto, California (B.D.D.).

Verbatim Formal Study Abstract

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.

Publication Classification: Journal Article Randomized Controlled Trial Multicenter Study

NLM MeSH Descriptors: Humans Analgesics, Opioid Female Chronic Pain Male Middle Aged Drug Tapering Cognitive Behavioral Therapy Adult Patient-Centered Care Self-Management Pain Management