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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT010352 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meditation | Experimental | Subjects 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. |
|
| meditation | Experimental | Subjects 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SF-12 Health Survey (SF-12) Physical Functioning | This is a 12-item version of the SF-12 item Health Survey designed to assess general mental and physical functioning, and overall health-related quality of life. We used the physical functioning SF-12 scale and collected this information before and after each intervention and by group. The total range of scores is from 0 - 100. The minimum total score is 0 and the maximum score is 100. Higher scores indicate better functioning. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fadel Zeidan, PhD | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical and Translational Research Institute | La Jolla | California | 92093 | United States | ||
| UC San Diego Center for Mindfulness |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12237198 | Background | 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. | |
| 10470716 | Background | 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. |
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88 out of the 500 individuals were enrolled and participated in the baseline session. Seventeen out of the 88 were not randomized for the following reasons: Not responsive to straight leg raise test (n = 4), Intolerance to pain procedures (n = 3), Withdrew (n = 3), Scheduling issues (n = 1), Transportation issues (n = 1), Positive opioid test (n = 1), Inappropriate behavior (n = 1), Other pain management (n = 1), instruction incomprehension (n = 1) and Mindfulness experience (n = 1).
500 individuals were screened for eligibility through the UCSD Recruitment services and study flyers. Enrollment started in January 2021 and data collection was completed in December of 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Meditation and Saline First | After providing informed consent, 18 participants completed baseline testing. Participants then completed a four session mindfulness meditation intervention where participants were taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation. One participant dropped out after the first intervention session. After their respective intervention, these participants received IV saline in session 6. Two participants were dismissed because of trouble administering the IV. Saline: 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. After a two day washout period, 15 participants returned to the clinic and performed the naloxone infusion in session 7. Naloxone: 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 administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment. |
| FG001 | Non Mindfulness Meditation and Saline First | After providing informed consent, 18 participants completed baseline testing. 2 participants withdrew from this session Participants then completed a four session non-mindfulness meditation intervention where participants were taught to independently practice closing their eyes and take a deep breath every few minutes. After their respective intervention, these participants received IV saline in session 6. One participants was dismissed because of trouble administering the IV. After a two day washout period, 15 participants returned to the clinic and performed the naloxone infusion in session 7. |
| FG002 | Mindfulness Meditation and Naloxone First | After providing informed consent, 17 participants participated in baseline testing. Two participants withdrew for scheduling issues after baseline. Fifteen participants then completed a four session mindfulness meditation intervention where they were taught to focus on the changing sensations of the breath non-reactively After their respective intervention, these 15 participants received IV naloxone in session 6 After a two day washout period, 15 participants returned to the clinic and performed the saline infusion in session 7. |
| FG003 | Non Mindfulness Meditation and Naloxone First | After providing informed consent, 18 participants participated in baseline testing. Three participants withdrew for scheduling issues after baseline. Fifteen participants then completed a four session non mindfulness meditation intervention where they were taught to independently take deep breaths. After their respective intervention, these participants received IV naloxone in session 6. However, a study nurse unintentionally instructed a patient that naloxone was to be infused and thus the participant was dismissed. After a two day washout period, 14 participants returned to the clinic and performed the saline infusion in session 7. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population was not different from the assignment in participant flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Meditation | Subjects 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. Mindfulness: 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. Naloxone: 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. Saline: 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. Meditation: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
|
Adverse events were evaluated from informed consent to data completion. This was observed in each study participant for an average of 8 weeks (i.e., through study completion).
Adverse Event: any problematic medical occurrence in a subject during study participation. Adverse events were assessed in each study participant from the time of informed consent to study completion (on average of 8 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Meditation During Pain Testing, Saline and Naloxone Infusion | All participants were administered the straight leg raise test across all testing sessions. After their respective interventions, participants were administered the straight leg raise test during naloxone and saline infusion, respectively. Naloxone: 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. Saline: 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. |
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The most significant limitation was performing highly invasive pain and pharmacologic testing during the coronavirus pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fadel Zeidan | UC San Diego | 858-246-8342 | zeidanlaboratory@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2023 | Aug 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2023 | Aug 2, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 26, 2019 | Sep 5, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D009270 | Naloxone |
| D012965 | Sodium Chloride |
| D019122 | Meditation |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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Only the study physician, research coordinator, and research pharmacist will be aware of drug assignments. Research staff (nurses; research technicians) and the PI will be blinded to drug assignment.
|
| Naloxone | Drug | 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. |
|
| Saline | Other | 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. |
|
| Meditation | Behavioral | 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. |
|
|
| 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. |
| 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. | 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. |
| 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. | 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. |
| Up to 8 weeks. Administered at visit 1, 6 and 7. Outcome measurements will compare SF-12 health survey from baseline to session 7. |
| San Diego |
| California |
| 92122 |
| United States |
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| 26985045 | Background | Zeidan F, Adler-Neal AL, Wells RE, Stagnaro E, May LM, Eisenach JC, McHaffie JG, Coghill RC. Mindfulness-Meditation-Based Pain Relief Is Not Mediated by Endogenous Opioids. J Neurosci. 2016 Mar 16;36(11):3391-7. doi: 10.1523/JNEUROSCI.4328-15.2016. |
| 26586819 | Background | Zeidan F, Emerson NM, Farris SR, Ray JN, Jung Y, McHaffie JG, Coghill RC. Mindfulness Meditation-Based Pain Relief Employs Different Neural Mechanisms Than Placebo and Sham Mindfulness Meditation-Induced Analgesia. J Neurosci. 2015 Nov 18;35(46):15307-25. doi: 10.1523/JNEUROSCI.2542-15.2015. |
| 19853530 | Background | Zeidan F, Gordon NS, Merchant J, Goolkasian P. The effects of brief mindfulness meditation training on experimentally induced pain. J Pain. 2010 Mar;11(3):199-209. doi: 10.1016/j.jpain.2009.07.015. Epub 2009 Oct 22. |
| 22487846 | Background | Zeidan F, Grant JA, Brown CA, McHaffie JG, Coghill RC. Mindfulness meditation-related pain relief: evidence for unique brain mechanisms in the regulation of pain. Neurosci Lett. 2012 Jun 29;520(2):165-73. doi: 10.1016/j.neulet.2012.03.082. Epub 2012 Apr 6. |
| 20363650 | Background | Zeidan F, Johnson SK, Diamond BJ, David Z, Goolkasian P. Mindfulness meditation improves cognition: evidence of brief mental training. Conscious Cogn. 2010 Jun;19(2):597-605. doi: 10.1016/j.concog.2010.03.014. Epub 2010 Apr 3. |
| 20666590 | Background | Zeidan F, Johnson SK, Gordon NS, Goolkasian P. Effects of brief and sham mindfulness meditation on mood and cardiovascular variables. J Altern Complement Med. 2010 Aug;16(8):867-73. doi: 10.1089/acm.2009.0321. |
| 26083664 | Background | Zeidan F, Lobanov OV, Kraft RA, Coghill RC. Brain mechanisms supporting violated expectations of pain. Pain. 2015 Sep;156(9):1772-1785. doi: 10.1097/j.pain.0000000000000231. |
| 21471390 | Background | Zeidan F, Martucci KT, Kraft RA, Gordon NS, McHaffie JG, Coghill RC. Brain mechanisms supporting the modulation of pain by mindfulness meditation. J Neurosci. 2011 Apr 6;31(14):5540-8. doi: 10.1523/JNEUROSCI.5791-10.2011. |
| 23615765 | Background | Zeidan F, Martucci KT, Kraft RA, McHaffie JG, Coghill RC. Neural correlates of mindfulness meditation-related anxiety relief. Soc Cogn Affect Neurosci. 2014 Jun;9(6):751-9. doi: 10.1093/scan/nst041. Epub 2013 Apr 24. |
| 11452128 | Background | Zubieta JK, Smith YR, Bueller JA, Xu Y, Kilbourn MR, Jewett DM, Meyer CR, Koeppe RA, Stohler CS. Regional mu opioid receptor regulation of sensory and affective dimensions of pain. Science. 2001 Jul 13;293(5528):311-5. doi: 10.1126/science.1060952. |
| 12077205 | Background | Zubieta JK, Smith YR, Bueller JA, Xu Y, Kilbourn MR, Jewett DM, Meyer CR, Koeppe RA, Stohler CS. mu-opioid receptor-mediated antinociceptive responses differ in men and women. J Neurosci. 2002 Jun 15;22(12):5100-7. doi: 10.1523/JNEUROSCI.22-12-05100.2002. |
| 37985872 | Derived | Khatib L, Dean JG, Oliva V, Riegner G, Gonzalez NE, Birenbaum J, Cruanes GF, Miller J, Patterson M, Kim HC, Chakravarthy K, Zeidan F. The role of endogenous opioids in mindfulness and sham mindfulness-meditation for the direct alleviation of evoked chronic low back pain: a randomized clinical trial. Neuropsychopharmacology. 2024 Jun;49(7):1069-1077. doi: 10.1038/s41386-023-01766-2. Epub 2023 Nov 20. |
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| nurse accidentally unblinded subject |
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| BG001 | Non-mindfulness Meditation | Subjects 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. Mindfulness: 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. Naloxone: 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. Saline: 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. Meditation: 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. |
| BG002 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Numerical pain ratings | Straight leg raise test induced numerical pain ratings were assessed using an 11-point scale where the minimum rating ("0") was designated as "no pain sensation" and the maximum ("10") as "most intense pain imaginable". Pain ratings were collected while patients were lying on backs and in response to the straight leg raise test (SLR). The following ratings correspond to the first SLR in the baseline session. Higher numerical ratings equated to higher pain. | Mean | Standard Deviation | units on a scale |
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| OG001 | Non Mindfulness Meditation | Subjects 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. Mindfulness: 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. Naloxone: 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. Saline: 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. Meditation: 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. |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Other Pre-specified | SF-12 Health Survey (SF-12) Physical Functioning | This is a 12-item version of the SF-12 item Health Survey designed to assess general mental and physical functioning, and overall health-related quality of life. We used the physical functioning SF-12 scale and collected this information before and after each intervention and by group. The total range of scores is from 0 - 100. The minimum total score is 0 and the maximum score is 100. Higher scores indicate better functioning. | Posted | Mean | Standard Deviation | units on a scale | Up to 8 weeks. Administered at visit 1, 6 and 7. Outcome measurements will compare SF-12 health survey from baseline to session 7. |
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| Post-Hoc | Perceived Intervention Effectiveness Was Assessed With a VAS ("0" = Not Effective at All; "10" = Most Effective Imaginable) for Each Intervention Session. | Posted | Mean | Standard Deviation | units on a scale | Delivered after completion of each of the 4 meditation intervention sessions. Up to 8 weeks. |
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| 35 |
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| 35 |
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| 35 |
| EG001 | Non-mindfulness Meditation During Pain Testing, Saline and Naloxone Infusion | All participants were administered the straight leg raise test across all testing sessions. After their respective interventions, participants were administered the straight leg raise test during naloxone and saline infusion, respectively. Naloxone: 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. Saline: 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. | 0 | 36 | 0 | 36 | 0 | 36 |
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| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| baseline BPI interference |
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| session 7 BPI interference |
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| intervention 3 effectiveness |
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| intervention 4 effectiveness |
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