Evaluating Cannabidiol (CBD) to Enhance the Analgesic Effect of Hydromorphone in Humans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale
研究概览
简要总结
This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of studies.
详细描述
This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) would change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with no history of drug use disorder. Study subjects and staff were completed blinded to the study drugs and the class of drugs under investigation and were informed that subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. All participants completed all sessions. Sessions lasted up to 8-hours and were conducted at least 7 days apart on an outpatient basis. Primary outcomes were collected from participants prior to dosing and at several hour periods post-dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study drug administration will be concealed from all study staff and participants to prevent bias in outcomes.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-75
- •Urine sample tests negative for common illicit substances of abuse, including cannabis
- •Medically cleared to take study medications
- •Are not pregnant or breast feeding
- •Willing to comply with the study protocol.
排除标准
- •Meet DSM-5 criteria for alcohol/substance use disorder
- •Taking opioids for pain
- •Previous adverse reaction to a cannabinoid product
- •Prescribed and taking stimulants or benzodiazepines
- •Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain
- •Self-report any illicit drug or cannabinoid use in the past 7 days
- •Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
- •History of seizure disorder
- •Have a known allergy to the study medications or sesame seed oil
- •ALT or AST levels >3x ULN and/or Bilirubin levels >2x ULN during Screening
- •Current (past 60-day) suicidal thoughts or past year history of suicidal behavior
- •Taking medications contraindicated with hydromorphone or cannabidiol
- •Have a history of clinically significant cardiac arrhythmias or vasopastic disease
- •Have an abnormal and clinically-significant ECG
研究组 & 干预措施
Placebo+Placebo
Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5.
干预措施: Within-subject test of blinded study medications (Drug)
Hydromorphone+Placebo
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1.
干预措施: Within-subject test of blinded study medications (Drug)
Hydromorphone (oral) 4mg + Cannabidiol 50mg
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5.
干预措施: Within-subject test of blinded study medications (Drug)
Hydromorphone (oral) 4mg + Cannabidiol 100mg
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5.
干预措施: Within-subject test of blinded study medications (Drug)
Hydromorphone (oral) 4mg + Cannabidiol 200mg
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5.
干预措施: Within-subject test of blinded study medications (Drug)
结局指标
主要结局
Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale
时间窗: 8 hour study session
Peak self-report rating of "Drug Effect" on a 0 ("none at all") to 100 ("extremely") visual analog scale as a function of double- blinded study medication, wherein higher values indicate stronger subjectively-experienced drug effects.
Peak Number Accurate on Circular Lights
时间窗: 8 hour study session
Peak number accuracy on the Circular Lights fine motor task as a function of double-blinded study drug administration. Participants were provided 60 seconds to press buttons that are lit in randomized order and displayed automatically on a circular lights wall mounted unit. The primary outcome is the number of lit buttons that were accurately pressed within 60 seconds, which is a metric to assess fine motor impairment. Lower numbers are indicative of greater drug-related impairment. There is no upper limit on the circular lights task.
Peak Cold Pressor Tolerance
时间窗: 8 hour study session
Peak amount of time participant submerged hand in cold pressor (5 degree circulating cold water) laboratory test of pain as a function of double- blinded study medications (range 0 -300).
次要结局
未报告次要终点