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临床试验/NCT03679949
NCT03679949已完成1 期

Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
26
试验地点
1
主要终点
Subjective Effects

研究概览

简要总结

The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.

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, Investigator)

入排标准

年龄范围
21 Years 至 53 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or non-pregnant female aged 21-53 years
  • Previous cannabis use
  • Previous opioid use
  • Urine test positive for recent cannabis use
  • Being able to perform all study procedures
  • Currently practicing an effective form of birth control (women only)

排除标准

  • Meeting criteria for some Use Disorders
  • Report regular illicit drug use
  • If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process revealed any significant illness

研究组 & 干预措施

Placebo

Placebo Comparator

Participants will receive 0 mg oxycodone (oral) and placebo cannabis (vaporized)

干预措施: Placebo (Drug)

Oxycodone

Experimental

Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)

干预措施: Oxycodone (Drug)

Oxycodone

Experimental

Participants will receive 2.5 mg oxycodone (oral) and placebo cannabis (vaporized)

干预措施: Placebo (Drug)

Cannabis (THC:CBD = ~1:0)

Experimental

Participants will receive 0 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)

干预措施: Placebo (Drug)

Cannabis (THC:CBD = ~ 0:1)

Experimental

Participants will receive 0 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)

干预措施: Placebo (Drug)

Cannabis (THC:CBD = ~ 1:1)

Experimental

Participants will receive 0 mg oxycodone (oral) and cannabis with equal CBD and THC concentrations (vaporized)

干预措施: Placebo (Drug)

Cannabis (THC:CBD = ~1:0) + Oxycodone

Experimental

Participants will receive 2.5 mg oxycodone (oral) and cannabis with high THC concentrations (vaporized)

干预措施: Oxycodone (Drug)

Cannabis (THC:CBD = ~ 0:1) + Oxycodone

Experimental

Participants will receive 2.5 mg oxycodone (oral) and cannabis with high CBD concentrations (vaporized)

干预措施: Oxycodone (Drug)

Cannabis (THC:CBD = ~ 1:1) + Oxycodone

Experimental

Participants will receive 2.5 mg oxycodone (oral) and cannabis with equal concentrations of THC and CBD (vaporized)

干预措施: Oxycodone (Drug)

结局指标

主要结局

Subjective Effects

时间窗: 6 weeks

Participants will rate "drug liking", "good drug effects", and "high" on a visual analogue scale (VAS; 1-100mm).

Cold Pressor Test

时间窗: 6 weeks

Participants will immerse their hand in a bucket of ice water to determine pain threshold and pain tolerance latencies (in seconds).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caroline A. Arout, Ph.D.

Research Scientist

New York State Psychiatric Institute

研究点 (1)

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