Acute Dose-Dependent Effects of Oral THC on Physiological and Subjective Responses in Healthy Cannabis-Experienced Adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- State Trait Anxiety Inventory - State
研究概览
简要总结
The goal of this clinical trial is to learn how a investigational medicinal product (THC) affects psychological and physical responses in healthy adults with prior cannabis use experience. The main questions it aims to answer are:
- How do different dose levels of the investigational medicinal product (THC) influence short-term subjective and physiological responses?
Researchers will compare three dose levels of the study drug to a placebo (a look-alike substance with no active ingredient) to see how responses vary across sessions.
Participants will:
- Attend four in-person study visits, each involving a single dose of either the study drug or placebo
- Complete questionnaires about their moment-to-moment experiences
- Have their heart rate, blood pressure, and other physical measures monitored
- Undergo serial blood sampling to measure circulating biomarkers
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-55
- •No major medical or psychiatric conditions
- •At least one previous, well-tolerated experience with cannabis
- •Not currently pregnant or breastfeeding
排除标准
- •Family history (first- or second-degree relatives) of bipolar disorder, psychosis, or schizophrenia
- •Significant negative reaction to cannabis in the past or known allergy to cannabis products
- •Currently using recreational drugs
研究组 & 干预措施
Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (6mg) (Drug)
Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (6mg) (Drug)
Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (9mg) (Drug)
Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (15mg) (Drug)
Oral Study Drug: AVCN6mg -> AVCN9mg -> AVCN15mg -> Placebo
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: Placebo (Drug)
Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (9mg) (Drug)
Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (15mg) (Drug)
Oral Study Drug: AVCN9mg -> AVCN15mg -> Placebo -> AVCN6mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: Placebo (Drug)
Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (6mg) (Drug)
Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (9mg) (Drug)
Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (15mg) (Drug)
Oral Study Drug: AVCN15mg -> Placebo -> AVCN6mg -> AVCN9mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: Placebo (Drug)
Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (6mg) (Drug)
Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (9mg) (Drug)
Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: AVCN319301b (15mg) (Drug)
Oral Study Drug: Placebo -> AVCN6mg -> AVCN9mg -> AVCN15mg
3 Doses of AVCN319301b (6mg, 9mg, 15mg) and placebo, each separated by >1 week washout period. Each participant receives all interventions in a double-blind randomized order based on a 4 sequence reverse Williams crossover design.
干预措施: Placebo (Drug)
结局指标
主要结局
State Trait Anxiety Inventory - State
时间窗: Baseline and multiple points up to 300 minutes post-dose.
The STAI-S is a validated self-report questionnaire that measures how anxious or calm a person feels "right now." Participants rate statements about current stress, worry, or relaxation on a 4-point scale. Scores are summed to provide a total anxiety rating. Higher scores reflect greater momentary anxiety. This measure is repeated throughout each session to track short-term changes in emotional state following study drug or placebo.
次要结局
- Subjective Drug Effects (Drug Effects Questionnaire; DEQ)(Baseline and multiple points up to 300 minutes post-dose.)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Adverse event recording begins with receiving the first dose of investigational medicinal product and ends one week following the last dose of investigational medicinal product (end of study).)
- Mood States (Profile of Mood States; POMS)(Baseline and multiple points up to 300 minutes post-dose.)
- Positive and Negative Affect (PANAS-SF)(Baseline and multiple points up to 300 minutes post-dose.)
- Heart Rate(Continuous measurements from baseline to 300 minutes post-dose.)
- Heart Rate Variability(Continuous measurements from baseline to 300 minutes post-dose.)
- Blood Pressure(Continuous measurements from baseline to 300 minutes post-dose.)
- Cortisol Levels(Blood samples collected at multiple points from baseline to 300 minutes post-dose.)
- Endocannabinoid Levels(Blood samples collected at multiple points from baseline to 300 minutes post-dose.)
- Cmax of Δ9-THC and its Metabolites(Blood samples collected at multiple points from baseline to 300 minutes post-dose.)
- Tmax of Δ9-THC and its Metabolites(Blood samples collected at multiple points from baseline to 300 minutes post-dose.)