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PainEarly Phase 1NCT04034004

Chronic Low Back Pain and Meditation

A Early Phase 1 study testing Mindfulness, Naloxone and Saline in people with Pain, run by University of California, San Diego at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pain
What is being tested?
Mindfulness, Naloxone and Saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
2 sitesUnited States
Study dates
1 Jan 2021to 22 Dec 2022
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Altman Clinical and Translational Research Institute

    La Jolla, California, 92093

  • UC San Diego Center for Mindfulness

    San Diego, California, 92122

Other trials in United States

About this study

Official title: The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief

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.

Read the detailed description

The purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (IV) of naloxone/placebo-saline. The aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.

Conditions
Pain
Being tested
Mindfulness, Naloxone, Saline, Meditation
Keywords
Mindfulness, Opioids, Pain, Naloxone
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MindfulnessBehavioural

    Also called mental training

    A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.

  • NaloxoneDrug

    A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.

  • SalineOther

    A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.

  • MeditationBehavioural

    Also called mental training

    A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.

Study groups in NCT04034004
Study groupRoleWhat they receive
MeditationExperimentalSubjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Receives: Behavioral: Mindfulness; Drug: Naloxone; Other: Saline; Behavioral: Meditation
meditationExperimentalSubjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
Receives: Behavioral: Mindfulness; Drug: Naloxone; Other: Saline; Behavioral: Meditation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Ratings

    Numerical pain ratings (NRS) will be assessed while lying on the back and in response to the straight leg raise test (SLR). Pain ratings will be collected during SLR 1 and SLR 2 in the baseline, saline and naloxone sessions, respectively. The 11 point scan will include a minimum rating of "0" which is characterized as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable"." Higher numbers correspond to higher pain.

    Measured: Pain ratings were collected while lying supine and in response to the straight leg raise test. Collected twice, once in the first half and one in the second half of the baseline, saline infusion and naloxone infusion sessions. Up to 8 weeks total.

Secondary outcomes (3)

  1. Pain Catastrophizing Scale

    This is a 13-item questionnaire with 3 subscales assessing rumination, magnification, and helplessness in patients. A numeric value between 0 (not at all) and 4 (all the time) is provided in response to each statement. Scores on this assessment range from 0 to 52, with higher values reflecting more salient impacts of pain on one's day to day experience. The total range is from 0 - 52.

    Measured: The Pain Catastrophizing Scale was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare change in Pain Catastrophizing Scale from baseline to session 7.

  2. The Roland-Morris Disability Questionnaire (RMDQ)

    The Roland-Morris Questionnaire (RMDQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMDQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. Higher scores indicate greater disability. Total RMDQ scores are used before and after each intervention by group. The range of scores is from 0 - 24.

    Measured: The Roland-Morris Disability Questionnaire was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare RMDQ from baseline to session 7.

  3. Brief Pain Inventory (BPI)

    Pain severity and interference: impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. Higher scores indicate higher chronic pain. BPI severity and interference scales are used and collected before and after each intervention. Higher BPI severity indicate higher chronic pain severity. Higher BPI interference scores indicate higher chronic pain interference.The scoring scale for severity and interference range from 0 - 10, respectively.

    Measured: Administered at the baseline, post-intervention session 6 and post-intervention session 7. Outcome measurements will compare in BPI severity and interference from baseline to session 7.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2019
  2. Study start1 Jan 2021
  3. Primary completion22 Dec 2022
  4. Study completion22 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
The study will employ a double blinded crossover factorial design. Baseline pain ratings will be assessed using visual analog scales obtained during three sessions where low back pain is induced. Study volunteers will participate in a four session (20min/session) meditation intervention. After meditation training, subjects will report to the UCSD Altman Clinical and Translational Research Institute across two separate experimental sessions. Half of the volunteers will be administered naloxone (opioid antagonist; 0.15 mg/kg bolus+ 0.1 mg/kg/hour infusion) and the other in the subsequent session will be administered IV placebo-saline, vice versa.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04034004
Sponsor's protocol ID
190709
Other IDs
R21AT010352
Status last verified
Oct 2023
First submitted
9 May 2019
Last updated
11 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Anderson WS, Sheth RN, Bencherif B, Frost JJ, Campbell JN. Naloxone increases pain induced by topical capsaicin in healthy human volunteers. Pain. 2002 Sep;99(1-2):207-16. doi: 10.1016/s0304-3959(02)00103-3.

    PubMed 12237198

  • Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.

    PubMed 10470716

  • Apkarian AV, Krauss BR, Fredrickson BE, Szeverenyi NM. Imaging the pain of low back pain: functional magnetic resonance imaging in combination with monitoring subjective pain perception allows the study of clinical pain states. Neurosci Lett. 2001 Feb 16;299(1-2):57-60. doi: 10.1016/s0304-3940(01)01504-x.

    PubMed 11166937

  • Bencherif B, Fuchs PN, Sheth R, Dannals RF, Campbell JN, Frost JJ. Pain activation of human supraspinal opioid pathways as demonstrated by [11C]-carfentanil and positron emission tomography (PET). Pain. 2002 Oct;99(3):589-598. doi: 10.1016/S0304-3959(02)00266-X.

    PubMed 12406535

  • Brown CA, Matthews J, Fairclough M, McMahon A, Barnett E, Al-Kaysi A, El-Deredy W, Jones AKP. Striatal opioid receptor availability is related to acute and chronic pain perception in arthritis: does opioid adaptation increase resilience to chronic pain? Pain. 2015 Nov;156(11):2267-2275. doi: 10.1097/j.pain.0000000000000299.

    PubMed 26176892

  • Bruehl S, Burns JW, Passik SD, Gupta R, Buvanendran A, Chont M, Schuster E, Orlowska D, France CR. The Contribution of Differential Opioid Responsiveness to Identification of Opioid Risk in Chronic Pain Patients. J Pain. 2015 Jul;16(7):666-75. doi: 10.1016/j.jpain.2015.04.001. Epub 2015 Apr 16.

    PubMed 25892658

  • Bruehl S, Chung OY. Parental history of chronic pain may be associated with impairments in endogenous opioid analgesic systems. Pain. 2006 Oct;124(3):287-294. doi: 10.1016/j.pain.2006.04.018. Epub 2006 May 24.

    PubMed 16725261

  • Bruehl S, Chung OY, Burns JW, Biridepalli S. The association between anger expression and chronic pain intensity: evidence for partial mediation by endogenous opioid dysfunction. Pain. 2003 Dec;106(3):317-324. doi: 10.1016/S0304-3959(03)00319-1.

    PubMed 14659514

  • Bruehl S, Chung OY, Burns JW, Diedrich L. Trait anger expressiveness and pain-induced beta-endorphin release: support for the opioid dysfunction hypothesis. Pain. 2007 Aug;130(3):208-215. doi: 10.1016/j.pain.2006.11.013. Epub 2007 Jan 2.

    PubMed 17197088

  • Bruno PA, Millar DP, Goertzen DA. Inter-rater agreement, sensitivity, and specificity of the prone hip extension test and active straight leg raise test. Chiropr Man Therap. 2014 Jun 16;22:23. doi: 10.1186/2045-709X-22-23. eCollection 2014.

    PubMed 24982755

  • Burns JW, Bruehl S, France CR, Schuster E, Orlowska D, Chont M, Gupta RK, Buvanendran A. Endogenous Opioid Function and Responses to Morphine: The Moderating Effects of Anger Expressiveness. J Pain. 2017 Aug;18(8):923-932. doi: 10.1016/j.jpain.2017.02.439. Epub 2017 Mar 30.

    PubMed 28365372

  • Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on Research Standards for Chronic Low Back Pain. Int J Ther Massage Bodywork. 2015 Sep 1;8(3):16-33. doi: 10.3822/ijtmb.v8i3.295. eCollection 2015 Sep.

    PubMed 26388962

  • Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009 Jan-Feb;22(1):62-8. doi: 10.3122/jabfm.2009.01.080102.

    PubMed 19124635

  • DosSantos MF, Martikainen IK, Nascimento TD, Love TM, Deboer MD, Maslowski EC, Monteiro AA, Vincent MB, Zubieta JK, DaSilva AF. Reduced basal ganglia mu-opioid receptor availability in trigeminal neuropathic pain: a pilot study. Mol Pain. 2012 Sep 24;8:74. doi: 10.1186/1744-8069-8-74.

    PubMed 23006894

  • Fardon DF. Nomenclature and classification of lumbar disc pathology. Spine (Phila Pa 1976). 2001 Mar 1;26(5):461-2. doi: 10.1097/00007632-200103010-00007. No abstract available.

    PubMed 11242371

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Mindfulness, Naloxone and Saline in people with Pain, run by University of California, San Diego at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Ratings (time frame: Pain ratings were collected while lying supine and in response to the straight leg raise test. Collected twice, once in the first half and one in the second half of the baseline, saline infusion and naloxone infusion sessions. Up to 8 weeks total.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04034004, which also lists 55 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.

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