PainEarly Phase 1NCT03419858

The Role of Opioidergic Systems in Breathing Based Analgesia

A Early Phase 1 study testing Mindfulness Meditation, Slow-Breathing and Naloxone in people with Pain, run by University of California, San Diego at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this psychophysical and pharmacologic study is to determine if slow-breathing induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during noxious heat stimulation. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: Mindfulness Meditation, Slow-Breathing and Naloxone
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 13 Mar 2017to 27 Jun 2017
Phase: Early Phase 1
Are there results?: None posted in the registry

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Normal volunteers with no history of chronic pain problems
Volunteers had no prior meditation experience
Volunteers could be male and non-pregnant females.
Volunteers of all ethnic backgrounds were included.

Who cannot join

Female volunteers could not be pregnant.
They could not be taking opioids or antidepressants.
Subjects with a repeated history of syncope, loss of consciousness, light headedness, nausea, dizziness, or vomiting in response to needles or blood could not participate in the study.
Subject could not be using exogenous opiates for the complete duration of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: The Role of Endogenous Opioidergic Systems in Breathing Based Analgesia

Read the detailed description

The proposed study will employ a graded analytical approach to compare mindfulness to placebo-meditation and a slow-breathing exercise in response to double-blind intravenous administration (IV) of naloxone/placebo-saline and noxious heat stimulation. The aim of this study is to determine if slow-breathing induced analgesia is associated with the release of endogenous opioids. The proposed study will disentangle the specific stage of cognitive and/or respiration-based involvement (if any) of opioidergically mediated pain relief, a critical step in identifying the specific analgesic mechanisms corresponding to mindfulness based cognitive techniques.

Conditions: Pain
Being tested: Mindfulness Meditation, Placebo Meditation, Slow-Breathing, Naloxone, Saline
Keywords: Pain, Slow-Breathing, Mindfulness, Opioids, Placebo
Medical subject headings: Pain, Hypoventilation

What participants receive

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

Mindfulness MeditationBehavioural
Also called mental training
A well-validated brief mindfulness-based mental training regimen [four sessions; 20 min/session] was used to teach patients to independently practice mindfulness meditation.
Placebo MeditationBehavioural
Also called mental training
A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] was used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Slow-BreathingBehavioural
Also called mental training
Study volunteers practiced lowering their breathing rate, across four, 20 minute training sessions, in response to a fluctuating light with the guidance of a trained facilitator.
NaloxoneDrug
A 0.15 mg/kg bolus dose of naloxone (Naloxone Hydrichloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion ceased till the end of the experiment.
SalineOther
A 0.15 mg/kg bolus dose of saline in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion ceased till the end of the experiment.

Study groups in NCT03419858
Study group	Role	What they receive
Mindfulness Meditation Group	Experimental	Subjects participated in four sessions (20 min/session) of mindfulness training. Participants were taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation. They were asked to close their eyes, relax and to focus on the flow of their breathing and "simply let go" of discursive thoughts. Receives: Behavioral: Mindfulness Meditation; Drug: Naloxone; Other: Saline
Placebo Meditation Group	Active comparator	The purpose of this intervention was to lead subjects to attend to one's breathing in a non-evaluative manner. Subjects were instructed to sit with a straight posture, closed eyes, and to take a deep, slow breaths every 2-3 minutes. Receives: Behavioral: Placebo Meditation; Drug: Naloxone; Other: Saline
Slow-Breathing Group	Active comparator	A validated (Chalaye et al., 2009) slow breathing training regimen was employed, using fluctuating light, to teach individuals to independently lower their respective respiration rate. Subjects practiced lowering their respiration rates across four, 20 minute sessions. Receives: Behavioral: Slow-Breathing; Drug: Naloxone; Other: Saline

What is being measured

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

Change in Visual Analog Scale Pain intensity and Unpleasantness ratings as a function of each respective cognitive manipulations and activation in response to naloxone and/or saline.
The visual analog scale (VAS) measures pain ratings that are assessed in response to noxious (49°C) thermal stimuli applied to the back of the right calf muscle.
Pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable". Higher values corresponded to higher perceived pain ratings.
Pain ratings were assessed at baseline (session 1) and again at sessions six and seven to determine the impact of the mental training regimens. At session six and seven, subjects were given an infusion of either naloxone or saline to address the potential contribution of the opioidergic system in the cognitive modulation of pain.
Measured: Up to 3 weeks

Secondary outcomes (9)

Respiration Rate Measures
A respiratory transducer (TSD 201; Biopac Systems) was placed around the chest to measure the participant's rate of respiration.
Measured: Up to 3 weeks
State Anxiety Inventory
This inventory is a 20 question test used to measure a subject's state of anxiety. A numeric value between 1 (Not at all) and 4 (Very Much So) is provided in response to each statement. The range of scores for this test is between 20 and 80, with higher scores reflecting higher estimates of anxiety.
Measured: up to 3 weeks
Pain Catastrophizing Scale (PCS)
The PCS is a 13 item scale, with each item rated on a 5-point scale between: 0 (Not at all) and 4 (all the time). The PCS is broken into three subscales including: magnification, rumination, and helplessness. The total range of scores is between 0-52 with higher values reflecting more salient impacts of pain on one's day to day experience.
Measured: up to 3 weeks
Cohen Perceived Stress Scale (CPS)
The CPS is a series of 10 temporally constrained (i.e. in the last month) questions meant to ascertain the relative frequency of stressors in one's life, ranging from never (scored as 0) to very often (scored as 4). All positively stated questions are reversed scored and then all items are summed to yield a final estimate of stress. The higher the score the higher the level of stress.
Measured: up to 3 weeks
Treatment Effectiveness Scale
A VAS assessed the effectiveness of the study's intervention. Values on this scale vary continuously between 0 (not effective) and 10 (most effective imaginable). Higher values indicate a subject's greater confidence in the perceived treatment effectiveness.
Measured: up to 3 weeks
Attitude Toward Treatment Scale (ATTS)
The ATTS was used to monitor a participant's impressions and attitudes about the interventions used in this study. It supplies 5 multiple-choice questions answered on a 10 point scale, ranging from 0 (not logical) to 9 (very logical). Higher scores reflect more positive subject impressions about the therapeutic interventions.
Measured: up to 3 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
This is a brief self-report questionnaire used to measure the severity of depressive symptoms. The CES-D is an inventory of 20 self-report items regarding depressive symptoms. Each question is graded on a 0 to 3 point scale with 0 representing "not at all" and 3 representing "a lot". Four questions (4,8,12, and 16) are reverse scored. A score of 15 or higher indicates a risk for depression.
Measured: up to 3 weeks
Stress-Level Visual Analogue Scale
A VAS was employed to measure subjective stress ratings. Values on this scale vary continuously between 0 (no stress) to 10 (most stress imaginable). Higher values indicate higher assessments of the subject's stress level.
Measured: up to 3 weeks
Naloxone Symptom Assessments
A numerical ratings scale was used to assess potential naloxone related symptomology after each clinical research unit session. "0" was designated as "non-existent" and "6" was characterized as "extremely strong". We measured symptoms corresponding to "dry mouth, dry skin, blurred vision, sedation, nausea, dizziness, and headache."
Measured: Up to 3 weeks

Timeline

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

13 Mar 201727 Jun 2017

First posted5 Feb 2018
Study start13 Mar 2017
Primary completion27 Jun 2017
Study completion27 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (40)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by University of California, San DiegoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 employed a double blind 3x2x2 crossover factorial design. Baseline pain intensity and pain unpleasantness ratings were assessed using visual analog scales (11 point) obtained before and after four, 5-minute noxious heat stimulation series (49°C). Study volunteers (20/group; 60 total) were randomized and subsequently participated in a four session (20min/session) mindfulness meditation, placebo-meditation, or slow-breathing training regimen. After training completion, subjects reported to the Wake Forest Clinical Research Unit to test the study hypotheses across two separate experimental sessions. Half of the study volunteers (n=10) from each group were administered naloxone (opioid antagonist; 0.15 mg/kg bolus+ 0.1mg/kg/hour infusion) and in the subsequent session were administered IV placebo-saline and vice versa.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03419858
Sponsor's protocol ID: IRB00040519
Status last verified: Jun 2019
First submitted: 16 Jan 2018
Last updated: 11 Jun 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Apkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.
PubMed 15979027
Bertisch SM, Wee CC, Phillips RS, McCarthy EP. Alternative mind-body therapies used by adults with medical conditions. J Psychosom Res. 2009 Jun;66(6):511-9. doi: 10.1016/j.jpsychores.2008.12.003. Epub 2009 Mar 3.
PubMed 19446710
Borras MC, Becerra L, Ploghaus A, Gostic JM, DaSilva A, Gonzalez RG, Borsook D. fMRI measurement of CNS responses to naloxone infusion and subsequent mild noxious thermal stimuli in healthy volunteers. J Neurophysiol. 2004 Jun;91(6):2723-33. doi: 10.1152/jn.00249.2003.
PubMed 15136603
Brown CA, Jones AKP. Meditation experience predicts less negative appraisal of pain: electrophysiological evidence for the involvement of anticipatory neural responses. Pain. 2010 Sep;150(3):428-438. doi: 10.1016/j.pain.2010.04.017. Epub 2010 May 21.
PubMed 20494517
Chalaye P, Goffaux P, Lafrenaye S, Marchand S. Respiratory effects on experimental heat pain and cardiac activity. Pain Med. 2009 Nov;10(8):1334-40. doi: 10.1111/j.1526-4637.2009.00681.x. Epub 2009 Aug 7.
PubMed 19671085
Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. Natl Health Stat Report. 2015 Feb 10;(79):1-16.
PubMed 25671660
Coghill RC, McHaffie JG, Yen YF. Neural correlates of interindividual differences in the subjective experience of pain. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8538-42. doi: 10.1073/pnas.1430684100. Epub 2003 Jun 24.
PubMed 12824463
Cusens B, Duggan GB, Thorne K, Burch V. Evaluation of the breathworks mindfulness-based pain management programme: effects on well-being and multiple measures of mindfulness. Clin Psychol Psychother. 2010 Jan-Feb;17(1):63-78. doi: 10.1002/cpp.653.
PubMed 19911432
Eippert F, Bingel U, Schoell ED, Yacubian J, Klinger R, Lorenz J, Buchel C. Activation of the opioidergic descending pain control system underlies placebo analgesia. Neuron. 2009 Aug 27;63(4):533-43. doi: 10.1016/j.neuron.2009.07.014.
PubMed 19709634
Friesner SA, Curry DM, Moddeman GR. Comparison of two pain-management strategies during chest tube removal: relaxation exercise with opioids and opioids alone. Heart Lung. 2006 Jul-Aug;35(4):269-76. doi: 10.1016/j.hrtlng.2005.10.005.
PubMed 16863899
Grant JA, Rainville P. Pain sensitivity and analgesic effects of mindful states in Zen meditators: a cross-sectional study. Psychosom Med. 2009 Jan;71(1):106-14. doi: 10.1097/PSY.0b013e31818f52ee. Epub 2008 Dec 10.
PubMed 19073756
Grant JA, Courtemanche J, Duerden EG, Duncan GH, Rainville P. Cortical thickness and pain sensitivity in zen meditators. Emotion. 2010 Feb;10(1):43-53. doi: 10.1037/a0018334.
PubMed 20141301
Grill JD, Coghill RC. Transient analgesia evoked by noxious stimulus offset. J Neurophysiol. 2002 Apr;87(4):2205-8. doi: 10.1152/jn.00730.2001.
PubMed 11929939
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
PubMed 7042457
Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985 Jun;8(2):163-90. doi: 10.1007/BF00845519.
PubMed 3897551

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Endogenous Opioidergic Systems in Breathing Based Analgesia
ClinicalTrials.gov ID: NCT03419858
Acronym / sponsor ID: IRB00040519
Conditions: Pain
Keywords: Pain, Slow-Breathing, Mindfulness, Opioids, Placebo
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Study start: 13 Mar 2017 (actual)
Primary completion: 27 Jun 2017 (actual)
Study completion: 27 Jun 2017 (actual)
First posted: 5 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3
Model description: The study employed a double blind 3x2x2 crossover factorial design. Baseline pain intensity and pain unpleasantness ratings were assessed using visual analog scales (11 point) obtained before and after four, 5-minute noxious heat stimulation series (49°C). Study volunteers (20/group; 60 total) were randomized and subsequently participated in a four session (20min/session) mindfulness meditation, placebo-meditation, or slow-breathing training regimen. After training completion, subjects reported to the Wake Forest Clinical Research Unit to test the study hypotheses across two separate experimental sessions. Half of the study volunteers (n=10) from each group were administered naloxone (opioid antagonist; 0.15 mg/kg bolus+ 0.1mg/kg/hour infusion) and in the subsequent session were administered IV placebo-saline and vice versa.

Arm	Type	Receives
Mindfulness Meditation Group	Experimental	Behavioral: Mindfulness Meditation, Drug: Naloxone, Other: SalineSubjects participated in four sessions (20 min/session) of mindfulness training. Participants were taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation. They were asked to close their eyes, relax and to focus on the flow of their breathing and "simply let go" of discursive thoughts.
Placebo Meditation Group	Active comparator	Behavioral: Placebo Meditation, Drug: Naloxone, Other: SalineThe purpose of this intervention was to lead subjects to attend to one's breathing in a non-evaluative manner. Subjects were instructed to sit with a straight posture, closed eyes, and to take a deep, slow breaths every 2-3 minutes.
Slow-Breathing Group	Active comparator	Behavioral: Slow-Breathing, Drug: Naloxone, Other: SalineA validated (Chalaye et al., 2009) slow breathing training regimen was employed, using fluctuating light, to teach individuals to independently lower their respective respiration rate. Subjects practiced lowering their respiration rates across four, 20 minute sessions.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Normal volunteers with no history of chronic pain problems
Volunteers had no prior meditation experience
Volunteers could be male and non-pregnant females.
Volunteers of all ethnic backgrounds were included.

Key exclusion criteria (4 listed)

Female volunteers could not be pregnant.
They could not be taking opioids or antidepressants.
Subjects with a repeated history of syncope, loss of consciousness, light headedness, nausea, dizziness, or vomiting in response to needles or blood could not participate in the study.
Subject could not be using exogenous opiates for the complete duration of the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness MeditationAlso: mental trainingA well-validated brief mindfulness-based mental training regimen [four sessions; 20 min/session] was used to teach patients to independently practice mindfulness meditation.	Behavioural	Mindfulness Meditation Group
Placebo MeditationAlso: mental trainingA well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] was used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.	Behavioural	Placebo Meditation Group
Slow-BreathingAlso: mental trainingStudy volunteers practiced lowering their breathing rate, across four, 20 minute training sessions, in response to a fluctuating light with the guidance of a trained facilitator.	Behavioural	Slow-Breathing Group
NaloxoneA 0.15 mg/kg bolus dose of naloxone (Naloxone Hydrichloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion ceased till the end of the experiment.	Drug	Mindfulness Meditation Group, Placebo Meditation Group, Slow-Breathing Group
SalineA 0.15 mg/kg bolus dose of saline in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion ceased till the end of the experiment.	Other	Mindfulness Meditation Group, Placebo Meditation Group, Slow-Breathing Group

Primary outcome

Change in Visual Analog Scale Pain intensity and Unpleasantness ratings as a function of each respective cognitive manipulations and activation in response to naloxone and/or saline.
Time frame: Up to 3 weeks
The visual analog scale (VAS) measures pain ratings that are assessed in response to noxious (49°C) thermal stimuli applied to the back of the right calf muscle. Pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable". Higher values corresponded to higher perceived pain ratings. Pain ratings were assessed at baseline (session 1) and again at sessions six and seven to determine the impact of the mental training regimens. At session six and seven, subjects were given an infusion of either naloxone or saline to address the potential contribution of the opioidergic system in the cognitive modulation of pain.

9 secondary outcomes

Respiration Rate Measures
Time frame: Up to 3 weeks
State Anxiety Inventory
Time frame: up to 3 weeks
Pain Catastrophizing Scale (PCS)
Time frame: up to 3 weeks
Cohen Perceived Stress Scale (CPS)
Time frame: up to 3 weeks
Treatment Effectiveness Scale
Time frame: up to 3 weeks
Attitude Toward Treatment Scale (ATTS)
Time frame: up to 3 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: up to 3 weeks
Stress-Level Visual Analogue Scale
Time frame: up to 3 weeks
Naloxone Symptom Assessments
Time frame: Up to 3 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
Background: PubMed 15979027Apkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.
Background: PubMed 19446710Bertisch SM, Wee CC, Phillips RS, McCarthy EP. Alternative mind-body therapies used by adults with medical conditions. J Psychosom Res. 2009 Jun;66(6):511-9. doi: 10.1016/j.jpsychores.2008.12.003. Epub 2009 Mar 3.
Background: PubMed 15136603Borras MC, Becerra L, Ploghaus A, Gostic JM, DaSilva A, Gonzalez RG, Borsook D. fMRI measurement of CNS responses to naloxone infusion and subsequent mild noxious thermal stimuli in healthy volunteers. J Neurophysiol. 2004 Jun;91(6):2723-33. doi: 10.1152/jn.00249.2003.
Background: PubMed 20494517Brown CA, Jones AKP. Meditation experience predicts less negative appraisal of pain: electrophysiological evidence for the involvement of anticipatory neural responses. Pain. 2010 Sep;150(3):428-438. doi: 10.1016/j.pain.2010.04.017. Epub 2010 May 21.
Background: PubMed 19671085Chalaye P, Goffaux P, Lafrenaye S, Marchand S. Respiratory effects on experimental heat pain and cardiac activity. Pain Med. 2009 Nov;10(8):1334-40. doi: 10.1111/j.1526-4637.2009.00681.x. Epub 2009 Aug 7.
Background: PubMed 25671660Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002-2012. Natl Health Stat Report. 2015 Feb 10;(79):1-16.
Background: PubMed 12824463Coghill RC, McHaffie JG, Yen YF. Neural correlates of interindividual differences in the subjective experience of pain. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8538-42. doi: 10.1073/pnas.1430684100. Epub 2003 Jun 24.
Background: PubMed 19911432Cusens B, Duggan GB, Thorne K, Burch V. Evaluation of the breathworks mindfulness-based pain management programme: effects on well-being and multiple measures of mindfulness. Clin Psychol Psychother. 2010 Jan-Feb;17(1):63-78. doi: 10.1002/cpp.653.
Background: PubMed 19709634Eippert F, Bingel U, Schoell ED, Yacubian J, Klinger R, Lorenz J, Buchel C. Activation of the opioidergic descending pain control system underlies placebo analgesia. Neuron. 2009 Aug 27;63(4):533-43. doi: 10.1016/j.neuron.2009.07.014.
Background: PubMed 16863899Friesner SA, Curry DM, Moddeman GR. Comparison of two pain-management strategies during chest tube removal: relaxation exercise with opioids and opioids alone. Heart Lung. 2006 Jul-Aug;35(4):269-76. doi: 10.1016/j.hrtlng.2005.10.005.
Background: PubMed 19073756Grant JA, Rainville P. Pain sensitivity and analgesic effects of mindful states in Zen meditators: a cross-sectional study. Psychosom Med. 2009 Jan;71(1):106-14. doi: 10.1097/PSY.0b013e31818f52ee. Epub 2008 Dec 10.
Background: PubMed 20141301Grant JA, Courtemanche J, Duerden EG, Duncan GH, Rainville P. Cortical thickness and pain sensitivity in zen meditators. Emotion. 2010 Feb;10(1):43-53. doi: 10.1037/a0018334.

Related trials for Pain

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fadel Zeidan, PhD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Mindfulness Meditation, Slow-Breathing and Naloxone in people with Pain, run by University of California, San Diego at 1 site 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 4 inclusion and 4 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Visual Analog Scale Pain intensity and Unpleasantness ratings as a function of each respective cognitive manipulations and activation in response to naloxone and/or saline. (time frame: Up to 3 weeks). 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 NCT03419858, which also lists 40 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 Jun 2019.