NCT07829939尚未招募1 期
Clinical Pharmacology of Oral Nicotine Pouches
适应症
干预措施
相关药物
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
- With multiple use of ONPs throughout the day, participants will titrate their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping.
研究概览
简要总结
The goal of this clinical trial is to understand how using oral nicotine pouches effects the body in healthy volunteers. The main questions it aims to answer are:
- With multiple use of oral nicotine pouches (ONPs) throughout the day, participants will adjust their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping.
- With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping. Participants will rate ONP use as a satisfactory substitute for cigarette smoking or vaping.
- Examine the cardiovascular effects (blood pressure and heart rate) of placebo, 3mg and 6mg ONPs, and the participants' usual cigarette or e-cigarette (vape).
Participants will:
- use 3 different strengths of ONPs (0 mg, 3 mg, 6 mg) and their usual inhaled nicotine product (cigarette or e-cigarette/vape)
- visit the hospital research ward on 4 separate days for 8 hours each day
- use one of each of the products in a randomized order (by chance, like flipping a coin) on each of the 4 hospital study days
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
- Single (Participant)
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
- •Healthy based on medical history and limited physical examination.
- •Heart rate < 105 BPM*
- •Systolic Blood Pressure < 160 and > 90*
- •Diastolic Blood Pressure < 100 and > 50*
- •*Considered out of range if both machine and manual readings are above/below these thresholds.
- •Body Mass Index ≤ 38.0
- •Willingness to abstain from illicit drug use for the duration of the study and cannabis for 48 hours prior to each hospital visit
- •Group 1 (n=12) Smoke cigarettes regularly (smoked 20 of past 30 days, 5 or more cigarettes per day)
- •Group 2 (n=12) use nicotine-containing e-cigarettes regularly (use on 20 of past 30 days)
- •Participants may be dual users of cigarettes and e-cigarettes, but during the study will use their predominant product (i.e., the product they use on more days in the past 30 and more frequently on days that they use it).
- •Saliva Cotinine >50 ng/ml
- •Age: ≥ 21 years old and ≤ 65 years old
- •Willingness to abstain from smoking all combustible products (tobacco and cannabis) for 12 hours before admission
- •Willingness to abstain from nicotine products (vaping/oral use) 12 hours before each admission
排除标准
- •• Unstable medical conditions:
- •Heart disease
- •Thyroid disease (okay if controlled with medication)
- •Hepatitis B or C or Liver disease
- •Kidney disease or urinary retention
- •An ulcer in the past year
- •Diagnosis of asthma or COPD
- •Drug/Alcohol Dependence
- •Alcohol or illicit drug dependence within the past 12 months (currently in treatment) with the exception of those who recently completed an alcohol/drug treatment program
- •Positive toxicology test at the screening visit (THC & prescribed medications okay)
- •Opioid replacement therapy (including methadone, buprenorphine, or other)
- •Psychiatric conditions
- •Current or past schizophrenia, and/or current or past bipolar disorder
- •Major depression, current or within the past year
- •Major personality disorder
- •Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the PI [study physician] and considered for inclusion
- •History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per PI's [study physician's] approval
- •Suicidal ideation within the past month
- •Current regular use of any psychiatric medications with the exception of SSRIs and SNRIs and current evaluation by the PI that the participant is otherwise healthy, stable, and able to participate
- •Congenital or acquired immunodeficiency disorders (i.e. HIV, congenital immune deficiency syndrome, chronic diseases)
- •Other disorders (i.e. ICU, malnutrition, immunosuppressive therapy)
- •Traumatic brain injury
- •Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks
- •Medications
- •Concurrent use of nicotine-containing medications
- •Any stimulant medications (ex. Adderall) generally given for ADHD treatment
- •Hypertension medications
- •Other/Misc. Chronic Health Problems
- •Oral thrush
- •Other "life threatening illnesses" as per study physician's discretion
- •Pregnancy
- •Pregnancy (self-reported and urine pregnancy test)
- •Breastfeeding (determined by self-report)
- •Concurrent participation in another clinical trial
- •Inability to communicate in English
- •Current regular user of ONPs
- •Planning to quit smoking or vaping within the next 60 days
- •Uncomfortable with getting blood drawn
研究组 & 干预措施
Placebo
Placebo Comparator
placebo (0 mg nicotine pouches) used on one study day (8 hours)
干预措施: 0 mg oral nicotine pouches (Drug)
3 mg ONP
Experimental
3 mg oral nicotine pouches used on one study day (8 hours)
干预措施: 3 mg oral nicotine pouches (Drug)
6 mg ONP
Experimental
6 mg oral nicotine pouches used on one study day (8 hours)
干预措施: 6 mg oral nicotine pouches (Drug)
Inhaled nicotine
Experimental
Participants will use their own brand of either cigarettes or e-cigarettes (vapes) on one study day (8 hours)
干预措施: cigarette or e-cigarette (Drug)
结局指标
主要结局
With multiple use of ONPs throughout the day, participants will titrate their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping.
时间窗: 7 hours post-dose
This will be assessed by comparing ratios of nicotine area under the plasma nicotine concentration time curve.
次要结局
- With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping.(Pre-dose until 7 hours post-dose.)
- Cardiovascular effects among arms using heart rate as a measure(Pre-dose until 7 hours post-dose)
研究者
研究点 (1)
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