Modulation of ∆9-tetrahydrocannabinol Acute Psychoactive Effects by Ranging Doses of Cannabidiol in Healthy, Occasional Cannabis Users: a Controlled, Triple Blind, Randomized, Cross-over Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective and subjective measures of cannabinoids effect
研究概览
简要总结
The purposes of this study are 1) to determine if CBD modulates THC-induced acute psychoactive effects at different CBD:THC ratios, compared with the control product (0:20, 20:20, 40:20, 80:20, 120:20) and 2) to determine if different doses of CBD modulate other THC induced behavioral effects, compared with the control product and 3)To explore qualitatively whether CBD modulates THC effects by mechanisms that are not detected with standard clinical research tools.
详细描述
Despite more than 40 years of research on the active compounds present in the cannabis plant, the influence of CBD consumption on the metabolism, pharmacology, and behavioral effects of THC remains fragmentary and scarcely documented in vivo in humans. Cannabis users are currently encouraged to choose products containing CBD, but evidence is lacking regarding its potential benefits when consumed jointly with THC across different ratios. Given the recent cannabis legalization in Canada and the widespread use of inhalation as the preferred mode of administration for non-therapeutic cannabis, closing this knowledge gap will help ensure public safety and allow regulatory bodies and public health authorities to elaborate more refined cannabis use guidelines and harm reduction strategies. It will also empower people who use cannabis to make more informed purchasing decisions and will drive the incubation of future research endeavors in the fields of medical and social sciences. The aim of this study is to improve our understanding of the (acute) behavioral and pharmacological effects of different doses of CBD administered concomitantly with THC via inhalation in individuals who engage in occasional cannabis use, taking into consideration multiple factors that can modulate such effects. This study will put to the test conceptions surrounding the interaction between specific cannabinoids by evaluating the role of CBD on the modulation of THC's effects pertaining to cognition, behavior, subjective experience, and physiological parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 21 and 49 years of age, inclusively;
- •Have used cannabis at least once in their lifetime and have used cannabis three days or less in the 30 days prior to enrollment;
- •Be able to provide a signed informed consent;
- •Willing to comply with study procedures and requirements as per protocol;
- •Have a forced expiratory volume in first second (FEV) less than or equal to 90 %;
- •Able to communicate and understand English or French language;
- •For female participants:
- •a. No 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. For female of childbearing potential: i. Must have negative pregnancy test result at screening and at subsequent visits.
- •ii. AND have no pregnancy plan while on the study iii. AND must agree to use a medically accepted method of birth control throughout the study.
- •Exclusion criteria
- •Participants will be excluded if any of the following criteria are met:
- •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;
- •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;
- •Known chronic liver disease or aspartate transaminase/alanine transaminase (AST/ALT) two times higher than upper limit of normal values at screening visit;
- •Blood pressure higher than 130/80 mmHg;
- •Kidney disorders;
- •Bleeding disorders;
- •Current moderate or severe DSM-5 substance use disorder (except nicotine) according to 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 cannabis.
- •Participation in clinical studies or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomization.
- •Resting heart rate over 100 beats per minute.
- •Current body mass index (BMI) over 29.9 kg/m
- •Any clinically significant electrocardiogram abnormalities at screening visit.
排除标准
- 未提供
研究组 & 干预措施
CBD:THC Group 1
Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).
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: ∆9-tetrahydrocannabinol (Drug)
CBD:THC Group 2
Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).
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: ∆9-tetrahydrocannabinol (Drug)
CBD:THC Group 3
Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).
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: ∆9-tetrahydrocannabinol (Drug)
CBD:THC Group 4
Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).
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: ∆9-tetrahydrocannabinol (Drug)
CBD:THC Group 5
Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).
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: ∆9-tetrahydrocannabinol (Drug)
结局指标
主要结局
Objective and subjective measures of cannabinoids effect
时间窗: Prior to the Product administration ,10 minutes and 80 minutes after inhalation
Based on the scores obtained on the observer items (objective) and the participant-rated items (subjective) from the Clinician Administered Dissociative State Scale (CADSS). The CADSS is a 28-item validated instrument, includes 5 observer items and 23 participant self-report items rated on a 5-point scale, ranging from 0 (not at all) to 4 (extremely) on eight items. The score will reflect the extent to which participants were observed to be under the effect of cannabinoids, i.e., in adissociative state.
次要结局
- Positive and Negative Affect(Prior to the Product administration , 10 minutes and 80 minutes post inhalation)
- Neural oscillations(Prior to the Product administration, 80 minutes post inhalation and at the end of the study visit, approximatively 140 minutes after inhalation)
- Anxiety Symptoms(Prior to the Product administration, 10 minutes and 80 minutes after inhalation)
- Success of Blinding Questionnaire(10 minutes and 140 minutes after inhalation)
- Subjective Drug Effects(10 minutes and 80 minutes after inhalation)
- Change on cognition(Prior to the Product administration (only at Visite 1) and 10 minutes after inhalation at each visit)
- Experience with Study Products(140 minutes after inhalation)
- Social Exposition Challenge(70 minutes after inhalation)
- Inhalation Adherence(During inhalation procedure)
- Change in Safety(Baseline,10 minutes, 80 minutes and 140 minutes after inhalation)
- Visit Intoxication Assessment(Through study visit completion, approximatively 140 minutes after product inhalation)