Design and methods of the Care Management for the Effective Use of Opioids (CAMEO) trial

Michael A. Bushey, James Slaven, Samantha D. Outcalt, Kurt Kroenke, Carol Kempf, Amanda Froman, Christy Sargent, Brad Baecher, Alan Zillich, Teresa M. Damush, Chandan Saha, Dustin D. French, Matthew J. Bair*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


Low back pain is the most common pain condition seen in primary care, with the most common treatment being analgesic medications, including opioids. A dramatic increase in opioid prescriptions for low back pain over the past few decades has led to increased non-medical use and opioid overdose deaths. Cognitive behavioral therapy (CBT) for chronic pain is an evidence-based non-pharmacological treatment for pain with demonstrated efficacy when delivered using collaborative care models. No previous studies have tested CBT compared to analgesic optimization that includes opioid management in primary care. This paper describes the study design and methods of the CAre Management for the Effective use of Opioids (CAMEO) trial, a 2-arm, randomized comparative effectiveness trial in seven primary care clinics. CAMEO enrolled 261 primary care veterans with chronic (6 months or longer) low back pain of at least moderate severity who were receiving long-term opioid therapy and randomized them to either nurse care management focused on analgesic treatment and optimization (MED) or cognitive behavioral therapy (CBT). All subjects undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months by interviewers blinded to treatment assignment. The primary outcome is pain severity and interference, measured by the Brief Pain Inventory (BPI) total score. Secondary outcomes include health-related quality of life, fatigue, sleep, functional improvement, pain disability, pain beliefs, alcohol and opioid problems, depression, anxiety, and stress.

Original languageEnglish (US)
Article number106456
JournalContemporary Clinical Trials
StatePublished - Jul 2021


  • Care management
  • Chronic low back pain
  • Cognitive behavioral therapy
  • Collaborative care
  • Long-term opioid therapy
  • Randomized clinical trial

ASJC Scopus subject areas

  • Pharmacology (medical)


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