Investigation of the Effects of Cannabis on the Immune-genome in People With HIV
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in Dronabinol-induced transcriptome profile in blood using single cell (sc)RNA-seq
研究概览
简要总结
The purpose of this study is to define the mechanisms of cannabis on the genome of people with HIV who use cannabis. The investigator aims to better understand the effect of Dronabinol on immune and inflammatory functions, and whether these changes are HIV-status dependent. This research may better inform public health policy regarding cannabis use. Depending on the results, additional studies may also build upon this research to develop more effective and specific treatments for cannabis use associated disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current or past Cannabis use.
- •HIV-positive on antiretroviral therapy.
- •Meet criteria of viral suppression (viral load less than approximately 400 copies/ml).
- •Good physical and mental health as determined by history, the SCID, collateral information, physical and laboratory examinations, ECG, and vital signs.
- •Women of Childbearing Potential: Must agree to use or have their partner use one acceptable method of birth control throughout the study, at the discretion of the principal investigator.
- •PWoH Inclusion Criteria:
- •Current or past Cannabis use.
- •Good physical and mental health as determined by history, the SCID, collateral information, physical and laboratory examinations, ECG, and vital signs.
- •Women of Childbearing Potential: Must agree to use or have their partner use one acceptable method of birth control throughout the study, at the discretion of the principal investigator.
排除标准
- •Cannabis naïve individuals.
- •Under the age of 18 years.
- •Unable to provide written informed consent.
- •Unable to read or write in English.
- •Unable to tolerate the effects of smoking approximately half a joint of cannabis (or equivalent), at the discretion of the principal investigator.
- •Major or clinically unstable medical conditions (e.g., myocardial infarction, hypertension, clinically significant head injury or loss of consciousness).
- •IQ less than
- •Diagnosis of psychosis confirmed by SCID.
- •Other medical, psychiatric, or psychosocial history that is deemed unsuitable for participation in study per PI.
- •Has donated blood within the last 8 weeks.
- •Sesame oil allergy.
- •Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants (e.g., barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants).
- •Patients with cardiac disorders or concomitant use of other drugs that are associated with similar cardiac effects (e.g., amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, other tricyclic antidepressants).
- •Patients with a history of seizures, including those receiving anti-epileptic medication or with other factors that can lower the seizure threshold.
研究组 & 干预措施
People with HIV (PWH) with Cannabis use
PWH with cannabis use
干预措施: Dronabinol Capsules (Drug)
People without HIV (PWoH) with Cannabis use
PWoH with Cannabis use
干预措施: Dronabinol Capsules (Drug)
结局指标
主要结局
Change in Dronabinol-induced transcriptome profile in blood using single cell (sc)RNA-seq
时间窗: Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol
Changes at baseline, 120 minutes, and 360 minutes post oral Dronabinol. Transcriptome will be profiled by using single cell (sc)RNA-seq in blood samples. A panel of 45 cytokines and profiling of 37 immune cell types will be assessed for functional evaluation after Dronabinol administration.
次要结局
- Change in Dronabinol-induced chromatin structure profile in blood samples using single cell (sc)ATAC-seq(Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol, up 5 years)
- Identification of Dronabinol related cellular gene networks in blood samples(up 5 years)