Meditation-CBT for Opioid-treated Chronic Low Back Pain
CompletedPhase 1, Phase 2NCT01775995
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. It is often refractory to treatment, with patients requiring long-term opioid therapy. Mindfulness meditation is a promising treatment for chronic pain, mental health and addictive disorders. When combined with cognitive behavioral therapy (CBT), a standard of care for CLBP, it may produce additive benefits. The goal of this randomized controlled trial (RCT) is to evaluate the feasibility and efficacy of an innovative behavioral intervention to improve the health of adults with opioid-treated CLBP. This RCT will test the hypotheses that, at 26 weeks, meditation-CBT group participants (meditation-CBT + usual care), compared to those in a wait-list control group (usual care alone), will improve health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome). In addition, they will also decrease alcohol and drug use/misuse, and improve stress-sensitive measures and economic outcomes.
Study details
- Official title
- Randomized Controlled Trial of Mindfulness Meditation and Cognitive Behavioral Therapy Intervention for Opioid-treated Chronic Low Back Pain
- Conditions
- Interventions
- Behavioral: Meditation-CBT Intervention + Usual Care
- Other: Usual Care Alone
- Sponsor
- University of Wisconsin, Madison
- Start date
- 2013-01
- Primary completion
- 2013-12
- Sex
- All
- Age range
- from 21 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age ≥ 21 years old * Chronic low back pain defined as a daily pain in the lumbosacral region or radiating to the leg (sciatica) * Pain lasting for and treated with clinician-prescribed daily opioids (≥ 30mg of morphine equivalent dose, MED) for ≥ 3 months * Has the ability to feel warm and cold temperature sensations in both hands (for pain psychophysical testing) * English fluent Exclusion Criteria: * Experience in meditation (current, regular practice in the past 12 months or past formal training) * Inability to reliably participate * Self-reported current pregnancy * Preexisting delusional, bipolar, or borderline personality disorders * Individuals lacking consent capacity and prisoners
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01775995