A Multicenter, Parallel group, Double-blind, Placebo-controlled, Randomized, Efficacy and Safety Study of Nicotine Freshmint Mouthspray in E-cigarette Users Willing to Quit - CCSSMC005220

McNeil AB0 个研究点目标入组 800 人开始时间: 2023年9月18日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: McNeil AB
入组人数: 800

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Has signed and dated the informed consent document before participating in any trialspecific procedures, indicating the participant has been informed of all pertinent aspects of the trial., Is able to comprehend the requirements of the trial (based upon clinical site personnel’s assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified within the protocol., Is a healthy participant over and including the age of 18 years. Healthy is defined as the absence of clinically relevant abnormalities as judged by the investigator., Have a history of daily nicotine intake from vaping for at least 3 months prior to screening visit, Want to become nicotine free with ‘high’ to ‘very high’ motivation based on the screening motivation assessment., Are classified as either moderately or highly dependent on the Penn State Electronic Cigarette Dependence Index (PS-ECDI), which corresponds to a total score of 9 or greater., Are exclusive e-cigarette users. Please see the protocol for more detaiils., For females: Postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first IP administration) or premenopausal /perimenopausal state with an effective means of contraception., For males: No pregnant or lactating spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the trial and for 30 days thereafter., Able to read and understand the local language.

排除标准

•Use of other forms of tobacco / nicotine-containing product(s) other than e-cigarettes within 7 days before screening., Participants can not have used marijuana for 28 days prior to screening and/or who have any plans to at any point throughout the trial, including prescription., Use of medications other than contraceptives or those prescribed for well-controlled medical conditions., Females who are pregnant or breastfeeding, or planning to become pregnant, or males who have partners who are pregnant or are planning to become pregnant., Is hypersensitive, intolerant, or experienced an allergic reaction to the active ingredient(s) or excipients of drug products used in the trial., Participating in a clinical trial and/or treated with any investigational product within 28 days or 5 half-lives, whichever is longer, before screening., Is related to persons involved directly or indirectly with the conduct of this trial (i.e., principal investigator, sub-investigators, trial coordinators, other trial personnel, employees of J&J subsidiaries, contractors of J&J, and the families of each)., History of epilepsy or seizures, Has pre-planned surgery, procedures, or personal commitments that would interfere with the conduct of the trial., Other clinically significant severe, acute or chronic, medical or psychiatric condition(s) that may increase the risk associated with trial participation or investigational product administration or may interfere with a participants participation and/or the interpretation of trial results, and in the judgment of the medically qualified investigator, would make the participant inappropriate for entry into this trial., Use of other forms of tobacco / nicotine-containing product(s) other than e-cigarettes between the screening and baseline visits., Use of other smoking cessation medications or aid(s) within 28 days before screening (e.g. NRT, buproprion, varenicline, cytisine, counselling, apps, acupuncture, or hypnosis)., History of recent or unstable cardiovascular disease, e.g. heart attack or stroke within the last 3 months or unstable or worsening angina pectoris, severe irregular heartbeat, high blood pressure not controlled by medicine, a stomach ulcer, or diabetes not controlled by oral medication only., Presence of an oral lesion (suspected malignant lesion and/or erosive lesion) found at the baseline visual mouth inspection, requiring further investigation such as biopsy., Presence of oral lesion(s) that, in the opinion of the investigator, cover more than 25% of the mucosal surface of the mouth so that absorption of the IP could be impaired., History of alcohol abuse, within 6 months of screening., History of non-prescription substance abuse (e.g., amphetamines, benzodiazepines, cocaine, THC, opioids), within 6 months of screening., A positive urine drug test at screening.

研究者

发起方

McNeil AB

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