Investigating Stress-related Mechanisms in the Laboratory and Real World in Individuals With Cannabis Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Rating of craving in the laboratory
研究概览
简要总结
This research project proposes a novel approach to elucidate the biological adaptations associated with Cannabis Use Disorder and to assess whether such adaptations are predictive of higher drug craving in response to both drug cues and stressors in both the laboratory and real-world, and higher relapse risk and drug use in the real world.
详细描述
The intent of this study is to recruit 25 treatment-seeking individuals with Cannabis Use Disorder (CUD) and 25 light users (<1 joint/week) to complete three guided imagery conditions (stress, cannabis, neutral) in inpatient research units. During the guided imagery, repeated measurements of subjective (i.e., craving, negative affect), neuroendocrine (i.e., cortisol), and physiological variables (i.e., heart rate variability [HRV]) will be collected. Thereafter, individuals with CUD will begin one-month of drug counseling treatment coupled with surveys delivered via smartphones daily in the morning, evening, and at four random times during the day.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cannabis using men and women who:
- •Are fluent in English;
- •Are using cannabis at levels to match either of the two groups:
- •a) Light Users: i. Cannabis using levels of < 1 joint/week ii. Has never met DSM-5 criteria for CUD or other substance use disorders. b) Individuals with Cannabis Use Disorder: i. Meets criteria for CUD based on the SCID (≤ 2 symptoms in past year); ii. Has a past-year cannabis use pattern of ≤3 times per week; iii.Do not meet criteria for any other substance use disorders other than mild Alcohol Use Disorder.
- •Provide a negative breathalyzer for alcohol and only positive for cannabis use at all appointments;
- •Can provide written informed consent.
排除标准
- •Meets current or past DSM-5 criteria for Axis I for major psychiatric disorders, other than depression or anxiety disorder;
- •Meets criteria for a current Substance Use Disorder other than Cannabis or mild Alcohol Use Disorder;
- •Has any significant current medical conditions requiring medication, including neurological, renal, thyroid, cardiovascular, liver, endocrine, or immune conditions;
- •Reports current use of medications/drugs that interfere with HPA axis response,
- •Are women who are pregnant or lactating, are peri-/post-menopausal, or those with hysterectomies;
- •Report current use of psychotropic drugs other than antidepressants.
结局指标
主要结局
Rating of craving in the laboratory
时间窗: 3 days
Participants will rate their level of stress and marijuana craving at five time points during the laboratory session, once at pre-baseline, baseline, immediately post-imagery procedures, and at three times point 15, 30, and 45 minutes post-imagery. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High." Individuals with CUD will be compared to light marijuana users in their differences in slope in response to the imagery.
Rating of subjective craving in the real world
时间窗: 28 days
Participants will report using ecological momentary assessment (EMA) their current levels of stress and craving, if they have used marijuana, and if they experienced a stressor. These reports will be generated in three different ways: at 8 am and 8 pm at night, at four random times during waking hours, and during marijuana use. Individuals with CUD will be compared to light marijuana users in their differences in real-world ratings of stress and craving. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High."
Heart rate response to stress and cannabis cues in the real world
时间窗: 2 weeks
Heart Rate Variability (HRV) will be collected throughout the day on two separate three-day occasions during Weeks 1 and Week 2 via the Firstbeat Bodyguard.
Rating of subjective stress in the laboratory
时间窗: 3 days
Participants will rate their level of stress and marijuana craving at five time points during the laboratory session, once at pre-baseline, baseline, immediately post-imagery procedures, and at three times point 15, 30, and 45 minutes post-imagery. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High." Individuals with CUD will be compared to light marijuana users in their differences in slope in response to the imagery.
Rating of subjective stress in the real world
时间窗: 28 days
Participants will report using ecological momentary assessment (EMA) their current levels of stress and craving, if they have used marijuana, and if they experienced a stressor. These reports will be generated in three different ways: at 8 am and 8 pm at night, at four random times during waking hours, and during marijuana use. Individuals with CUD will be compared to light marijuana users in their differences in real-world ratings of stress and craving. Craving and stress will be assessed using a 100-point visual analog scale (VAS) in which 0="Not at all" and 100="Extremely High."
Physiological response to stress and cannabis cues in the laboratory
时间窗: 3 days
Plasma will be collected at each laboratory session to assess cortisol response to stress, drug cue, and neutral imagery exposure. Heart Rate Variability (HRV) measured via the Firstbeat Bodyguard 2 will be used to assess cardiovascular response to stress, drug, and neutral cue imagery exposure.
次要结局
- Blood pressure- diastolic(2 weeks)
- Change in Cannabis use- Labs(4 weeks)
- Blood pressure- systolic(2 weeks)
- Change in Cannabis use- Self Report(4 weeks)
研究者
Stephanie Wemm
Associate Research Scientist
Yale University