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NCT01775995 · ClinicalTrials.gov registry record · Phase 1
Meditation-CBT for Opioid-treated Chronic Low Back Pain
A Phase 1 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT01775995: Completed Phase 1 study, sponsored by University of Wisconsin, Madison.
NCT01775995 is a Phase 1 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01775995, a Phase 1 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now. This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negat
Interventions
- BEHAVIORAL Meditation-CBT Intervention + Usual Care
- OTHER Usual Care Alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01775995 record still lists
NCT01775995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Meditation-CBT Intervention + Usual Care is the first listed.
NCT01775995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01775995 about?
NCT01775995 is a clinical study titled "Meditation-CBT for Opioid-treated Chronic Low Back Pain". 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 ...
What is the current status of trial NCT01775995?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2013-01. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01775995?
The interventions under investigation include: Meditation-CBT Intervention + Usual Care (BEHAVIORAL), Usual Care Alone (OTHER).
Who is sponsoring clinical trial NCT01775995?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01775995's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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