The Role of Endogenous Opioidergic Systems in Breathing Based Analgesia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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. We were also interested in disentangling the endogenous analgesic mechanisms supporting mindfulness-based analgesia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the study physician, research coordinator, and research pharmacist were aware of drug assignments. Research staff (nurses; research technicians) and the PI were not blinded to drug assignment.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Mindfulness Meditation Group
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.
干预措施: Mindfulness Meditation (Behavioral)
Mindfulness Meditation Group
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.
干预措施: Naloxone (Drug)
Mindfulness Meditation Group
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.
干预措施: Saline (Other)
Placebo Meditation Group
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.
干预措施: Placebo Meditation (Behavioral)
Placebo Meditation Group
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.
干预措施: Naloxone (Drug)
Placebo Meditation Group
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.
干预措施: Saline (Other)
Slow-Breathing Group
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.
干预措施: Slow-Breathing (Behavioral)
Slow-Breathing Group
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.
干预措施: Naloxone (Drug)
Slow-Breathing Group
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.
干预措施: Saline (Other)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Pain Catastrophizing Scale (PCS)(up to 3 weeks)
- Respiration Rate Measures(Up to 3 weeks)
- Treatment Effectiveness Scale(up to 3 weeks)
- Center for Epidemiological Studies Depression Scale (CES-D)(up to 3 weeks)
- Stress-Level Visual Analogue Scale(up to 3 weeks)
- Naloxone Symptom Assessments(Up to 3 weeks)
- State Anxiety Inventory(up to 3 weeks)
- Cohen Perceived Stress Scale (CPS)(up to 3 weeks)
- Attitude Toward Treatment Scale (ATTS)(up to 3 weeks)
研究者
Fadel Zeidan
Assistant Professor
University of California, San Diego