Human Laboratory Model to Screen Drugs With Opioid Analgesic-sparing Effects: Cannabidiol/Morphine Combinations
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- CHANGE: PAIN THRESHOLD AND TOLERANCE Pain responses to a range of heat, cold and mechanical pressure stimuli
研究概览
简要总结
The purpose of the proposed study is to investigate the interaction of cannabidiol (CBD) and morphine effects on pain sensitivity. Cannabidiol is a cannabinoid (similar to cannabis, or marijuana) present in marijuana that alters some of the effects of marijuana.
详细描述
Eligible participants will be asked to participate in a total of three experimental sessions with each session day separated by at least one week. Each session day will last approximately 6-7 hours.
In the morning of each of the three study sessions, participants will be asked to complete baseline assessments which include self-report questionnaires (answering questions about how they feel), vital sign measurements (blood pressure, heart rate, oxygen saturation, temperature, and pupillometry) will be taken using a non-invasive (external) vitals monitor, and lastly thermal (heat and cold) and mechanical sensitivity testing will be done.
Participants will be asked to take an oral morphine capsule.
Participants will participate in 2 smoking sessions where they will be asked to smoke cigarettes or a vaporizer balloon containing either cannabidiol or a placebo (a blank).
Participants will be asked to complete the same battery assessments mentioned above, which include self-report questionnaires (answering questions about how they feel); vital sign measurements (blood pressure, heart rate, oxygen saturation, temperature, and pupillometry) will be taken using a non-invasive (external) vitals monitor; and lastly thermal (heat and cold) and mechanical stimulation will be administered to test pain sensitivity.
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
- Double (Participant, Outcomes Assessor)
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
- •Participants must report having smoked a cigarette (nicotine or marijuana) AND having taken an opioid on 3 or more occasions in their lifetime.
- •Participants must be in good health to participate; those with certain contraindications will be excluded.
- •All participants will undergo psychiatric evaluation and will be asked to report their substance use history by interview and structured questionnaire methods.
- •Participants will undergo medical evaluations using medical history, physical exam, standard lab tests (complete blood chemistry, urinalysis, urine pregnancy test for females), and 12-lead ECG.
排除标准
- •Serious psychiatric illness (e.g. psychotic or bipolar disorder, recent suicide attempts; severe depression)
- •Substance Use Disorders other than Nicotine Use Disorder and Mild Cannabis Use Disorder
- •Neurological diseases; cardiovascular problems (e.g. systolic BP >140 or <95 mmHg, diastolic BP >90 mmHg, abnormal ECG); pulmonary diseases; systemic diseases (e.g. liver, renal, inflammatory)
- •Cognitive impairment (<80 IQ)
- •Past-month medications that increase study risk
- •Women who are pregnant (urine HCG), lactating (self-report), or if heterosexually active and not using (self-report) medically approved birth control (oral or depot contraception, IUD, condom/foam, sterilization, tubal ligation)
- •Individuals unable to give informed consent will be excluded.
研究组 & 干预措施
Smoked cannabidiol 0%
干预措施: Thermal and Pressure Nociceptive Sensitivity (Other)
Smoked cannabidiol 0%
干预措施: Immediate-release Oral Morphine Sulfate Tablets (Drug)
Smoked cannabidiol 9.7%
干预措施: Immediate-release Oral Morphine Sulfate Tablets (Drug)
Smoked cannabidiol 9.7%
干预措施: Thermal and Pressure Nociceptive Sensitivity (Other)
结局指标
主要结局
CHANGE: PAIN THRESHOLD AND TOLERANCE Pain responses to a range of heat, cold and mechanical pressure stimuli
时间窗: Pain responses measured at the start of the visit, baseline; 25 minutes post CBD 0% drug; 25 minutes post CBD 9.7% drug
Change in pain threshold and tolerance is being assessed post each CBD drug use (0%and 9.7%) using Q-Sense Conditioned Pain Modulation™. A randomized series of 7 heat stimuli and 7 cold stimuli will be delivered via a thermode attached to the lower nondominant arm. A series of 7 pressure stimuli will be delivered with a pressure algometer to the opposite arm.
次要结局
- SAFETY & INDICES OF ABUSE LIABILITY: Brief Pain Inventory(Measured at baseline only.)
- SAFETY: Heart rate(Heart Rate measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).)
- SAFETY: Systolic blood pressure (physiological effects)(Systolic blood pressure measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).)
- SAFETY: Diastolic blood pressure (physiological effects)(Diastolic blood pressure measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).)
- SAFETY: Pupillometry Measurement - Diameter of your eye(Pupillometry measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).)
- SAFETY & INDICES OF ABUSE LIABILITY: Drug Effect(Drug Liking measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).)
- SAFETY & INDICES OF ABUSE LIABILITY: Drug Symptoms(Drug Symptoms measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).)
- SAFETY & INDICES OF ABUSE LIABILITY: Mood and Feeling(Measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).)
- SAFETY & INDICES OF ABUSE LIABILITY: Feelings about self(Measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).)
- SAFETY: Temperature(Temperature measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).)
- SAFETY: Oxygen saturation(Oxygen Saturation measured at baseline; 30 and 45 minutes post-morphine; 15 minutes post CBD 0% drug; 15, 65, and 90 minutes post 9.7% CBD drug (final drug).)
研究者
Leslie Lundahl
Associate Professor
Wayne State University