Chronic Low Back Pain and Meditation
CompletedEarly phase 1NCT04034004
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)
The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.
Study details
- Official title
- The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief
- Conditions
- Interventions
- Behavioral: Mindfulness
- Drug: Naloxone
- Other: Saline
- Behavioral: Meditation
- Sponsor
- University of California, San Diego
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2021-01-01
- Primary completion
- 2022-12-22
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis * Participants must be between 18 and 65 years of age * Participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale * Participants must have experienced their chronic low back pain for at least 3 months * Participants must have no prior meditative experience * Participants must be straight leg raise test positive Exclusion Criteria: * Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period * Participants must not be taking opioids * Participants must not be pregnant or nursing mothers * Participants must have not had back surgery within the last year before their enrollment into the study * Participants must have not had any other sensory or motor deficits that preclude participation in this study * Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, and a personal history of psychosis * Participants must not have any known allergies to naloxone or similar drugs * Participants must not have a history of syncope and/or fear of needles/blood
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04034004