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临床试验/NCT06588582
NCT06588582招募中不适用

Exploring the Antecedents and Consequences of Cannabis Use in the Context of Coping: An Experimental Study

University of Colorado, Boulder1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2025年2月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
166
试验地点
1
主要终点
Blood Cortisol Levels

研究概览

简要总结

The purpose of the study is to better understand the effects of cannabis in relation to mental and physical states including its relationship with mood, cognition, perception including the experience of temperature and pain, and heart rate.

We expect that participants will be in this research study for approximately one week. The total amount of time that participants will spend completing study tasks will be about 2.5 hours across two separate in-person visits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21-65 years of age
  • Endorsement of at least some use of cannabis for coping purposes (>1 on CMMQ)
  • Regularly use flower cannabis products (i.e., ≥1x/week in the last 6 months)
  • Proficient in English language
  • At least occasional use of CBD+THC or CBD-dominant products (e.g., ≥1x/month)

排除标准

  • Diagnosis or use of medications for substance use or psychotic disorders
  • Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
  • Females cannot be pregnant or trying to become pregnant or nursing mothers
  • Not able to provide informed consent

研究组 & 干预措施

Warm Water

Placebo Comparator

干预措施: Water Temperature Variation - WW (Other)

Cold Water

Experimental

干预措施: Water Temperature Variation - CW (Other)

结局指标

主要结局

Blood Cortisol Levels

时间窗: Pre-Use/Pre-Water Task, 20 minutes Post-Use, 40 minutes Post-Use

Cortisol levels are measured in blood.

Cannabis Used

时间窗: Immediate Post-Use

Grams of product used is calculated. Product is measured before and after use to measure how much was used.

Blood Endocannabinoid Levels

时间窗: Pre-Use/Pre-Water Task, 20 minutes Post-Use

Blood levels of AEA are measured.

Heart Rate

时间窗: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use

Participant HR is measured via pulse oximeter.

Social Anxiety

时间窗: Pre-Use/Pre-Water Task

Social Interaction Anxiety Scale (SIAS). 20 item survey, questions are answered on scale of 0 (not at all) to 4 (extremely), with higher scores indicating higher social anxiety. Questions are summed, with higher overall scores indicating higher social anxiety.

Inhibitory Control

时间窗: Baseline

Go/No-go Task. Participants are asked to complete a cognitive task where they see the text "Go" or "No go" during different trials. When they see "Go", they need to push a button within 2 seconds. When they see "No-go", they need to make sure they do not press the button (for 2 seconds). This is a measure of impulsivity.

Stress

时间窗: Pre-Use/Pre-Water Task

Stress Subscale of Depression and Anxiety Stress Scale measures stress. On scale from 0 (does not apply to me at all) to 3 (apply to me very much or most of the time). Higher scores indicate higher stress levels.

Blood cannabinoid levels

时间窗: Pre-Use/Pre-Water Task, 20 minutes Post-Use

THC and CBD blood levels are measured.

Current Pain

时间窗: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use, 40 minutes Post-Use

Internal scale/measure, measured from 0 (no pain) to 10 (worst pain imaginable). Participants report current pain on this self-report scale.

Mood

时间窗: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use, 40 minutes Post-Use

Profile of Mood States (POMS). Focus on the stress, anxiety, tension, and relaxation questions (combined for a tension/anxiety subscale). Questions are on a scale 1 (not at all) to 5 (extremely). Scores are summed, with higher scores indicating more tension/anxiety.

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

Carillon Skrzynski

Research Assistant Professor

University of Colorado, Boulder

研究点 (1)

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