Effects of Drugs on Stress Memories
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in emotional responses after stress memory cues compared to control cues after delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. placebo
研究概览
简要总结
There is evidence that cannabinoids, including delta-9-tetrahydrocannabinol (THC), reduce responses to acute stress and fear-related stimuli, but few studies have examined the effects of THC on memories of stressful experiences. The researchers hypothesize that THC will attenuate behavioral and physiological responses to negative valence stimuli, including memories of aversive experiences.
详细描述
The current study will use a between subject, randomized, placebo-controlled design to assess the effects of low doses of delta-9-tetrahydrocannabinol (THC) on stress memories. Healthy male and female participants (N=48) will be randomly assigned to one of the three drug conditions (5 mg THC [n=16], 10 mg THC [n=16], or placebo [n=16]). Each subject will participate in 3 sessions. In the first session, they will undergo the TSST procedure. Researchers will obtain ratings of subjective distress, heart rate variability, and cortisol levels to assess response to the stressor for each individual. On the second session, one week later, participants will receive either THC or placebo and they will then be presented with TSST-related cues during a stress-memory retrieval session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-35 y/o
- •BMI 19-29 kg/m2
- •some prior experience with cannabis (used at least 4 times, no adverse experiences, and current use no more than once a week)
排除标准
- •Current severe substance use disorder
- •history of psychosis or mania
- •Lack of English fluency
- •Current DSM IV Axis I disorder
- •Abnormal EKG
- •Daily use of medications outside of contraception,
- •Women who are pregnant or trying to become pregnant
研究组 & 干预措施
placebo
Dextrose capsules
干预措施: Placebo (Drug)
5 mg delta-9-tetrahydrocannabinol (THC)
Marinol (dronabinol)
干预措施: delta-9-tetrahydrocannabinol (THC) (5) (Drug)
10 mg delta-9-tetrahydrocannabinol (THC)
Marinol (dronabinol)
干预措施: delta-9-tetrahydrocannabinol (THC) (10) (Drug)
结局指标
主要结局
Change in emotional responses after stress memory cues compared to control cues after delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. placebo
时间窗: baseline (5 minutes before memory task) and 20 seconds after each cue presentation during the task
Using a visual analog scale participants will rate feelings of 'distress' 'arousal' and 'valence'. Scores range from 0-100 with higher scores indicating greater responses on particular items
Change in physiological responses after stress memory cue presentation compared to control cues
时间窗: difference between values at baseline (5 minutes pre-task) and during 20 seconds of task cue presentations
Researchers will assess changes in cardiac output (pre-ejection period) after presentation of cues. This will be measured in milliseconds. Lower values indicate greater sympathetic activation.
Emotional Responses After Stress Memory Cues Compared to Control Cues After Delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. Placebo
时间窗: 20 seconds after each cue presentation during the task
Using a visual analog scale participants will rate feelings of 'distress' 'arousal' and 'valence'. Scores range from 0-100 with higher scores indicating greater responses on particular items
Mean Physiological Responses After Stress Memory Cue Presentation Compared to Control Cues
时间窗: difference between values during 20 seconds of task cue presentations
Researchers will assess changes in cardiac output (pre-ejection period) after presentation of cues. This will be measured in milliseconds. Lower values indicate greater sympathetic activation.
次要结局
- Change in negative facial emotion expressions during cue presentation after THC (5 and 10 mg) vs placebo(During 20 seconds cue presentation)
- Change in emotional responses one week later during non-drug retrieval session(1 week after the first exposure they will complete the memory task again. The timeframe for assessing changes in emotional responses will be at baseline (5 minutes pre-memory task) and 20 seconds after each cue presentation)
- Mean Emotional Responses One Week Later During Non-drug Retrieval Session(1 week after the first exposure they will complete the memory task again. The timeframe for assessing mean emotional responses will be at baseline (5 minutes pre-memory task) and 20 seconds after each cue presentation)
- Mean Negative Facial Emotion Expressions During Cue Presentation After THC (5 and 10 mg) vs Placebo(During 20 seconds cue presentation)