Using Dronabinol 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
- 29
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Seconds to Withdraw Hand From Cold Pressor Laboratory Pain Task
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 dronabinol (Marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid).
详细描述
This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid dronabinol (Marinol; 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)
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 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
- •Taking medications contraindicated with hydromorphone or dronabinol
- •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 (oral) 4mg + 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 / Dronabinol (oral) 2.5mg
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 2.5mg. Order of dose randomized session days 2-5.
干预措施: Within-subject test of blinded study medications (Drug)
Hydromorphone (oral) 4mg / Dronabinol (oral) 5mg
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 5.0mg. Order of dose randomized session days 2-5.
干预措施: Within-subject test of blinded study medications (Drug)
Hydromorphone (oral) 4mg / Dronabinol (oral) 10mg
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 10mg. Order of dose randomized session days 2-5 but was never the first hydromorphone 4mg + dronabinol combination dose.
干预措施: Within-subject test of blinded study medications (Drug)
结局指标
主要结局
Mean Change From Baseline in Seconds to Withdraw Hand From Cold Pressor Laboratory Pain Task
时间窗: Baseline and time of hand withdrawal from cold pressor, up to 60 seconds
Compare study conditions in seconds to withdraw hand from cold pressor laboratory pain task, where longer time periods reflect higher tolerance to pain.
Mean Change From Baseline in Maximum Percent Correct on Digit Symbol Substitution Test of Cognitive Behavior
时间窗: Baseline and 8-hours
Within-subject comparison of study conditions on the Digit Symbol Substitution Test (DSST), a measure of cognitive performance that is sensitive to drug effects, wherein lower percent scores reflect worse performance and suggest greater drug-related impairment.
Mean Peak Rating of "Drug Effect" (0-100) as Measured by the Visual Analog Rating Scale
时间窗: 8-hour study session
Mean peak of Visual Analog Scale ratings of Drug Effect (0-100) compared across each study condition, with higher ratings reflecting stronger drug effects.
次要结局
未报告次要终点