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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 is a Phase 1 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 35 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01775995
The ClinicalTrials.gov registry entry for NCT01775995 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Meditation-CBT Intervention + Usual Care is the first listed.
NCT01775995 reports 0 study locations.
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.
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