A Triple-blind, Placebo-controlled, Randomized, Crossover Study of Low Dose Oral Synthetic Cannabidiol Effects in Healthy Cannabis Occasional Users
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pleasant drug effect
研究概览
简要总结
The purposes of this study are 1) to determine if the administration of different low doses of oral CBD (20 mg, 50 mg, 100 mg and 200 mg) result in detectable subjective pleasant drug effect compared to placebo and 2) to qualitatively explore whether low dose of oral CBD is associated with effects that are not detected with the available research tools.
详细描述
Cannabis contains over 100 cannabinoids, the two most prominent being Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). A growing body of evidence exists surrounding the effects of both THC and CBD, however, less is known about the specific effects of CBD concentrations alone. Most existing data regarding the effects of CBD come from studies where this compound is administered in high doses in a therapeutic context, and where the subject can be administered either CBD, THC or both together. These contexts are not representative of the current use by many consumers. Indeed, several available products contain CBD at much lower doses. The overall objective of this study is to evaluate the acute behavioral and biological effects of low doses of ingested CBD (between 20-200mg) and placebo in occasional cannabis users. Potential outcomes not detected with usual assessment tools designed to evaluate THC-induced effects will also be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Between 21 and 65 years of age, inclusively;
- •Occasional users, having used cannabis three days or less in the 28 days prior to enrollment;
- •Be able to provide a signed informed consent;
- •Willing to comply with study procedures and requirements as per protocol, including to abstain from using other cannabis products or any drugs (except alcohol or nicotine) 7 days prior to study visits;
- •Able to communicate and understand English or French language;
- •For female participants:
- •a. Without childbearing potential, defined as: i. postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age); or ii. Documented surgically sterilized (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or b. With childbearing potential: i. Must have negative pregnancy test result at screening and at subsequent visits.
- •ii. AND have no pregnancy plan while on the trial. iii. AND agree to use a medically accepted method of birth control throughout the study.
排除标准
- •Any disabling medical condition, as assessed by medical history, physical exam, vital signs and/or laboratory assessments that, in the opinion of the study physician, precludes safe participation in the study or the ability to provide fully informed consent;
- •Known chronic liver disease or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >ULN (Upper Limit of Normal) at screening visit;
- •Mean systolic blood pressure >180 mmHg (millimeter of mercury);
- •Resting heart rate over 100 beats per minute (bpm);
- •Current body mass index (BMI) of over 40;
- •Must not have any clinically significant ECG abnormalities at screening visit;
- •Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or current suicidality based on the Mini International Neuropsychiatric Interview);
- •Any other disabling, unstable or acute mental condition that, in the opinion of the study physician, precludes safe participation in the study or ability to provide fully informed consent;
- •Current substance use disorder (except nicotine) according to Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders ( SCID-V);
- •Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study;
- •Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion;
- •Use of medication within 7 days of experimental sessions; which, in the opinion of the Investigator, may interact with CBD,
- •Participation in clinical trials or undergoing other investigational procedure related to cannabis or cannabinoid administration within 30 days prior to randomization.
研究组 & 干预措施
0 mg CBD, ingested placebo
Ingested placebo containing 0 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 50 mg (Drug)
0 mg CBD, ingested placebo
Ingested placebo containing 0 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: cannabis 0 mg, placebo (Drug)
0 mg CBD, ingested placebo
Ingested placebo containing 0 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 20 mg, (Drug)
0 mg CBD, ingested placebo
Ingested placebo containing 0 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 100 mg (Drug)
0 mg CBD, ingested placebo
Ingested placebo containing 0 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 200 mg (Drug)
20 mg CBD, ingested CBD
Ingested cannabis containing 20 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: cannabis 0 mg, placebo (Drug)
20 mg CBD, ingested CBD
Ingested cannabis containing 20 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 20 mg, (Drug)
20 mg CBD, ingested CBD
Ingested cannabis containing 20 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 50 mg (Drug)
20 mg CBD, ingested CBD
Ingested cannabis containing 20 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 100 mg (Drug)
20 mg CBD, ingested CBD
Ingested cannabis containing 20 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 200 mg (Drug)
50 mg CBD, ingested CBD
Ingested cannabis containing 50 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: cannabis 0 mg, placebo (Drug)
50 mg CBD, ingested CBD
Ingested cannabis containing 50 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 20 mg, (Drug)
50 mg CBD, ingested CBD
Ingested cannabis containing 50 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 50 mg (Drug)
50 mg CBD, ingested CBD
Ingested cannabis containing 50 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 100 mg (Drug)
50 mg CBD, ingested CBD
Ingested cannabis containing 50 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 200 mg (Drug)
100 mg CBD, ingested CBD
Ingested cannabis containing 100 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: cannabis 0 mg, placebo (Drug)
100 mg CBD, ingested CBD
Ingested cannabis containing 100 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 20 mg, (Drug)
100 mg CBD, ingested CBD
Ingested cannabis containing 100 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 50 mg (Drug)
100 mg CBD, ingested CBD
Ingested cannabis containing 100 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 100 mg (Drug)
100 mg CBD, ingested CBD
Ingested cannabis containing 100 mg CBD. Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 200 mg (Drug)
200 mg CBD, ingested CBD
Ingested cannabis containing 200 mg CBD Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: cannabis 0 mg, placebo (Drug)
200 mg CBD, ingested CBD
Ingested cannabis containing 200 mg CBD Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 20 mg, (Drug)
200 mg CBD, ingested CBD
Ingested cannabis containing 200 mg CBD Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 50 mg (Drug)
200 mg CBD, ingested CBD
Ingested cannabis containing 200 mg CBD Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 100 mg (Drug)
200 mg CBD, ingested CBD
Ingested cannabis containing 200 mg CBD Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit. The order in which the study products will be administered depend on the randomization sequence.
干预措施: Cannabis 200 mg (Drug)
结局指标
主要结局
Pleasant drug effect
时间窗: T5 (360 minutes after ingestion)
Pleasant drug effect will be assessed using a single item, visual analog scale, administered following administration of the study product at each study visit. It is rated on a continuous scale ranging from 0 (not at all) to 100 (extremely).
次要结局
- Drug Effects associated with cannabis ingestion(T5 (360 minutes after ingestion))
- Change in dissociation(Baseline and after ingestion at (120 minutes, 300 minutes))
- Cannabis-Specific Subjective Effects(T5 (360 minutes after ingestion))
- Change in Affect(Baseline and after ingestion at (120 minutes, 300 minutes))
- Change in Anxiety Symptoms(Baseline and after ingestion at (120 minutes, 300 minutes))
- Change in the incidence of Treatment Emergent-adverse Events(Baseline and after ingestion at (60 minutes, 120 minutes, 210 minutes, 300 minutes, 360 minutes))
- Change on cognition(Baseline and after ingestion at 210 minutes)
- Visit Intoxication Assessment(End of the visit, approximatively 360 minutes after ingestion)