跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT03559725
NCT03559725已完成1 期

Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes With Characterization of Nicotine Exposure Profiles in Adult Smokers

22nd Century Group, Inc.1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年5月1日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
55
试验地点
1
主要终点
Emax_urge(controlled)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to evaluate the abuse liability of mentholated very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes.

详细描述

This study will be a randomized, two-part, 3-way crossover designed to evaluate the abuse liability, pharmacokinetics (PK), and product use behavior associated with study products, including menthol VLN cigarettes, subjects' own-brand cigarettes, and nicotine polacrilex gum in healthy adult male and female exclusive smokers. Subjects will participate in a standard Screening visit and one 7-day Confined Assessment Phase, which will include a product trial session (Day -1), and two study parts (Part A and Part B). Following the Screening visit, eligible subjects will check-in to the study site on Day -1. Following the polacrilex gum training session, subjects will be required to abstain from nicotine- and tobacco-containing products for approximately 20 hours until the first product use session on Days 1 to 3; use of other nicotine-containing products will be prohibited throughout the study. No additional tobacco or nicotine products will be provided after the second product use on Days 4 to 6.

On Day 1, subjects will be randomized to one of three product sequence groups in Part A, which will consist of an ad libitum product use session for each of the following study products for 4 hours in a randomized crossover manner (Days 1 to 3; one product per day):

Product A: VLN menthol cigarette

Product B: Own-brand filtered standard king size menthol cigarette

Product C: 4 mg Nicotine polacrilex gum

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
None

入排标准

年龄范围
22 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Subjects will be required to meet each one of the following inclusion criteria in order to be eligible for participation in the study:
  • •Must provide written informed consent prior to the initiation of any protocol-specific procedures.
  • •Male and female adults, between 22 to 65 years of age, inclusive.
  • •Body mass index (BMI) within 18.0 to 35.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at Screening).
  • •Healthy, as determined by no clinically significant medical history, physical examination, 12-lead ECG, vital signs or laboratory (including hematology, clinical chemistry, urinalysis, and serology) findings at Screening, as judged by an investigator.
  • •Smoking history of an average of at least 10 manufactured filtered standard (i.e., not slim) king size combustible cigarettes daily for at least 1 year prior to Screening. Brief periods (i.e., up to 7 consecutive days) of non-smoking during the 3 months prior to Screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted.
  • •Self-reporting of desire to smoke within approximately 30 minutes of waking.
  • •Positive urine cotinine (≥500 ng/mL) at Screening.
  • •Negative pregnancy test at Screening and Day -1 (check-in) for all female subjects.
  • •Female subjects of non-childbearing potential must be surgically sterile or 1 year postmenopausal (as confirmed by serum Follicle Stimulating Hormone (FSH) > 35 U/L). A subject is considered to be surgically sterile if she has had a tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy. If the subject is of childbearing potential, she must be using a medically accepted method of contraception and agree to continued use of this method for the duration of the study and for 30 days after completion of the study. Acceptable methods of contraception include abstinence, birth control pill, or an intrauterine device (known to have a failure rate of less than 1% per year) or double barrier method of contraception (e.g., male condom in addition to a diaphragm, contraceptive sponge or spermicide).
  • •Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
  • •Must be willing to comply with the requirements and restrictions of the study.

排除标准

  • •Subjects will not be eligible to participate in this study if any one of the following exclusion criteria is met:
  • •Inability to tolerate 4 mg nicotine polacrilex gum during product use trial on Day -1 (check-in) or dentition prevents subjects from chewing gum.
  • •History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease at Screening, which in the opinion of an investigator would jeopardize the safety of the subject or the validity of the study results.
  • •History or presence of any type of malignant tumors.
  • •Clinically significant abnormal findings on the vital signs, physical examination (including oral exam), medical history, or clinical laboratory results, in the opinion of an investigator.
  • •Positive serology test results for human immunodeficiency virus (HIV-1/HIV-2) Antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C Antibody (HCVAb).
  • •An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks prior to Day -1 (check-in).
  • •Drug or alcohol abuse or dependence within the 24 months prior to Screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).
  • •Subjects who have ever been in treatment for substance use disorder(s) or who are currently
  • •Positive urine drug screen (UDS) or urine alcohol test at Screening or Day -1 (check-in).
  • •History or any current conditions that may interfere with drug absorption, distribution, metabolism, or excretion.
  • •History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus, or food allergies/intolerances/restrictions, or special dietary needs which, in the judgment of an investigator, contraindicates the subject's participation in the study.
  • •Requires concomitant treatment with prescription or non-prescription products that contain pseudoephedrine (e.g., nasal/sinus decongestants).
  • •Self-reported use of nicotine polacrilex gum, or other nicotine replacement therapy products in the 30 days prior to Day -1 (check-in). Isolated incidents within 30 days prior to Day -1 (check-in) may be permitted at the discretion of the investigator.
  • •Subject has unsuitable or difficult venous access or is unwilling or unable to undergo direct venipuncture or catheter insertion.
  • •Subject has donated or lost 100 to 499 mL whole blood within 30 days or more than 499 mL whole blood within 56 days preceding entry into the Confined Assessment Phase.
  • •Subject is an employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child or sibling, whether biological or legally adopted.
  • •Subject is lactating and or breast feeding.
  • •A subject who, in the opinion of an investigator, is considered unsuitable or unlikely to comply with the study protocol for any reason.

研究组 & 干预措施

Nicotine Gum (C)

Experimental

Subjects will chew nicotine gum

干预措施: VLN menthol cigarettes (A) (Other)

Nicotine Gum (C)

Experimental

Subjects will chew nicotine gum

干预措施: Usual Brand Menthol Cigarettes (B) (Other)

Usual Brand Menthol Cigarettes (B)

Experimental

Subjects will smoke their usual brand menthol cigarettes

干预措施: Nicotine gum (C) (Drug)

VLN Menthol Cigarettes (A)

Experimental

Subjects will smoke VLN menthol cigarettes

干预措施: Usual Brand Menthol Cigarettes (B) (Other)

VLN Menthol Cigarettes (A)

Experimental

Subjects will smoke VLN menthol cigarettes

干预措施: Nicotine gum (C) (Drug)

Usual Brand Menthol Cigarettes (B)

Experimental

Subjects will smoke their usual brand menthol cigarettes

干预措施: VLN menthol cigarettes (A) (Other)

结局指标

主要结局

Emax_urge(controlled)

时间窗: 3 days - administered at the end of each product use session (Use of each product on a different day)

The maximum reduction in Visual Analog Scale (VAS) score for the question "Urges to smoke" (Tobacco/Nicotine Withdrawal Questionnaire) between pre-use and post-use (i.e., VASpre-use1 - VASpost-use1) during the first product use in Part B.

次要结局

  • T1/2(controlled); Terminal Half Life(Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes)
  • Tmax(controlled); Maximum Time(Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes)
  • Tmax(uncontrolled); Maximum Time(Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes)
  • Kel(controlled); Elimination Rate Constant(Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes)
  • Cmax(uncontrolled); Maximum Nicotine Concentration(Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes)
  • Emax_urge (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minute)
  • AUC(controlled); Area under the nicotine concentration-time curve(Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes)
  • Kel(uncontrolled); Elimination Rate Constant(Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes)
  • Emax_impat (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • T1/2(uncontrolled); Terminal Half Life(Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes)
  • AUC(uncontrolled); Area under the nicotine concentration-time curve(Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes)
  • Emax_anx (Controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_impat (Controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_awake (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_hunger (Controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Inhalations(3 product use days (Use of each product on a different day))
  • Puff durations(2 product use days (Use of each product on a different day))
  • Emax_hunger (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_more (Controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_more (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_plst(controlled)(3 days - administered at the end of each product use session (Use of each product on a different day))
  • Emax_diffct (Controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_calm (Controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_conc (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_awake (controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Gum durations(1 product use day)
  • Emax_diffct (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_crav (Controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_plas (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_stf (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_stf (Controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_calm (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_conc (controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_sick (Controlled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Use Product Again(1 product use day)
  • Cmax(controlled); Maximum Nicotine Concentration(Pre, 2,5,7,10,12,15,20,30,45,60,90,120,150, and 180 minutes)
  • Emax_anx (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_crav (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)
  • Emax_sick (Uncontrolled)(pre, 5, 15, 30, 60, and 90 minutes)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Unknown
2 期
Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis BronchiectasisNon-cystic Fibrosis Bronchiectasis
NCT04278040Federal State Budgetary Institution, Pulmonology Scientific Research Institute7
招募中
不适用
Evaluation of efficacy and safety of low-level laser therapy for cancer therapy-induced oral mucositis
KCT0006073Soon Chun Hyang University Hospital Cheonan60
招募中
不适用
Prospective study for evaluating the safety of LECS as the option treatment for elderly gastric cancerGastric cancer
JPRN-UMIN000039807Kitasato University School of Medicine50
已完成
不适用
Pilot study for studying the influence of low-dose propofol on the classification of movements from the electroencephalogram in healthy participantsperioperatieve monitoringmonitoring during anesthesia
NL-OMON38459niversitair Medisch Centrum Sint Radboud12
进行中（未招募）
不适用
Influence of propofol on detection of movement in EEGIntraoperative awareness during general anesthesia
EUCTR2013-001592-20-NL