Impact of Chronic Nabilone Self-administration on Body Weight, Metabolic Markers, Gut Microbiota, and Neural Circuitry in Human Obesity
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of SAEs per treatment arm
研究概览
简要总结
Obesity is a serious health problem which increases the likelihood of developing other life-changing medical conditions. Despite increasing knowledge about the neural and metabolic basis of obesity, the development of effective anti-obesity treatment strategies has been a challenge. Evidence shows an association between cannabis consumption and body weight. However, to date, no human trials have assessed the potential of cannabis-like compounds to reduce body weight in individuals who are obese. This pilot trial aims to determine the safety and feasibility of administering nabilone (a cannabinoid drug similar to the active component of cannabis) to patients who are obese. Our secondary aims are to determine if nabilone is effective in reducing weight in this population, and to probe potential mechanisms of the weight-loss-promoting effects of nabilone, such as neural reactivity to food stimuli, changes in gut bacteria, and changes in metabolic biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese adults (BMI > 30.0 kg/m2).
- •For the optional imaging component of the study, a maximum weight (315 lbs) and a maximum girth in line with capacity of the machine (60 cm horizontal and 45 cm vertical; therefore, circumference of scanner is 166.6 cm)
- •For women of reproductive potential (WORP) and men whose sexual partners are WORP: use of adequate methods of contraception (effective barrier methods such as male condoms, female condoms, cervical caps, diaphragms, or contraceptive sponges; and highly effective methods of contraception such as oral hormonal contraceptives, intrauterine devices (IUDs), vasectomy, or tubal ligation)
- •AST/ALT, bilirubin, and kidney function tests within normal limits at screening.
排除标准
- •Unstable gastrointestinal, respiratory, endocrinological, cardiovascular or cerebrovascular diseases that would prevent participation in the trial at QI (or its delegate) discretion,
- •Unstable major psychiatric disorder(s) (i.e. Axis I Disorders) that would prevent participation in the trial at QI (or its delegate) discretion,
- •Current substance use disorders (DSM-V) (excluding tobacco and caffeine),
- •History of, or current neurological illnesses, that would prevent participation in the trial,
- •Current use or use during the previous month of antipsychotic medications,
- •Learning disability, amnesia or other conditions that impede memory and attention,
- •Visual impairments that prevent participation in the study,
- •Personal or family history of schizophrenia, or psychosis (or psychosis-related) disorders,
- •Antibiotic use in the last 4 weeks,
- •Previous bariatric surgery,
- •Current use or use in the past month of other weight-loss pharmaceuticals,
- •Cannabis use in last 6 months,
- •Known sensitivity to cannabis or other cannabinoid agents,
- •Pregnancy or lactation (females), and
- •For the optional imaging component of the study:
- •Presence of metal implants or objects unsafe for MRI such as cardiac pacemakers, metal fragments in the eye, and aneurysm clips in your brain
- •Piercings or jewelry that are unable to be removed
- •Tattoos inked with metal dyes
研究组 & 干预措施
High-Dose Nabilone
pms-nabilone titrated to 6 mg daily
干预措施: Nabilone (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
Low-Dose Nabilone
pms-nabilone titrated to 2 mg daily
干预措施: Nabilone (Drug)
结局指标
主要结局
Number of SAEs per treatment arm
时间窗: 12 weeks of treatment
Number of SAEs collected to assess nabilone safety
Number of dropouts per treatment arm
时间窗: 12 weeks of treatment
Number of dropouts collected to assess feasibility of study design and intervention
Number of SAEs Per Treatment Arm
时间窗: 12 weeks of treatment
Number of SAEs collected to assess nabilone safety
Number of Dropouts Per Treatment Arm
时间窗: 12 weeks of treatment
Number of dropouts collected to assess feasibility of study design and intervention
次要结局
- Blood glucose levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Blood leptin levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Neural reactivity to food vs. control stimuli(Baseline, Week 12)
- Abdominal fat(One scan at baseline and one scan at Week 12)
- Blood ghrelin levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Body weight(Baseline, then weekly for 12 weeks of treatment)
- Blood insulin levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Blood triglyceride levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Blood cholesterol levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Gut microbiota(Baseline, Week 12)
- Blood PYY levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Body Weight(Baseline, one weekly visit for Weeks 1-12, then one discharge visit (Week 13))
- Abdominal Fat(One scan at baseline and one scan at Week 12)
- Blood Glucose Levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Blood Insulin Levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Blood Triglyceride Levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Blood Cholesterol Levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Blood Leptin Levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Blood Ghrelin Levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Blood PYY Levels(Blood drawn at baseline, Week 5, Week 9, and Week 12)
- Gut Microbiota(Baseline, Week 12)
- Neural Reactivity to Food vs. Control Stimuli(Baseline, Week 12)