Clinical Research Directory

Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation

The purpose of this vanguard trial is to test whether clients of Sun Life are willing to join in a quit smoking program that offers counselling and tobacco cessation products to all participants over a 12-month period. The study team will track the safety and usage of 3 types of cessation products as well as the effectiveness of a virtual pharmacy (i.e. cessation products delivered to participants directly from a pharmacy). The goal is to recruit a minimum of 150 participants for this Vanguard phase. The purpose of this study is to look at 3 approved smoking cessation products used in combination with counselling and virtual delivery of the smoking cessation products. The goal is to track product usage, safety, and adherence (how much of the products people use and how many counselling sessions they complete). Within the study there will also be an observational group who will not receive study medication but who will receive free virtual coaching and follow-up for smoking cessation and complete study questionnaires.

Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking

Tobacco use is the leading cause of preventable death in the U.S., with 480,000 deaths per year and 7.7 million deaths globally. A major clinical symptom associated with abstinence from both licit and illicit drugs is insomnia, which is a clinically verified, major risk factor for relapse. Roughly half of the 40 million smokers in the U.S. attempt to quit annually, with very low rates of success. One major hurdle is poor sleep quality during abstinence. Compounding the problem is that some pharmaceuticals to help reduce smoking can increase insomnia. Poor sleep is recognized as a major impediment to maintaining abstinence from several drugs of abuse, including nicotine. Blockers of orexin have recently been proposed as a promising therapy for smoking cessation. Insomnia has been reported in up to 40% of smokers, and 80% report regular sleep disturbances, which can be amplified during abstinence. A new orexin blocker, daridorexant, was FDA approved within the past two years for the treatment of insomnia, and while it has been tested in healthy individuals with insomnia, it has not been tested in smokers, who suffer from insomnia, particularly during the withdrawal phase when trying to quit. Daridorexant has an improved profile of beneficial effects for those with insomnia, the most notable advantage being its shorter duration of action that promotes daytime alertness, which is problematic for both active smokers and smokers during withdrawal. Poor sleep leads to daytime sleepiness, which often leads to smoking to maintain alertness.

Acceptability of Mobile Applications (Apps) to Enhance Smoking Cessation in a Clinical Tobacco Treatment Program - A Pilot Study

We will conduct a small-scale randomized controlled trial (RCT) with 24 adult smokers enrolled in the TTP. Participants will receive either the Free4Good mobile app for positive psychology skills training or a breathing relaxation mobile app control (Breathe2Relax). All participants will be receiving tobacco cessation treatment in the Tobacco Treatment Program at MD Anderson as standard of care.

Quitting Matters Human Immunodeficiency Virus Hybrid Trial

The purpose of this study is to compare the advantages and disadvantages of two approaches for quitting smoking among people living with HIV (PWH). Participants will complete a 24- week (\~6-month) study where the Participants will be assigned to one of two smartphone apps to help with quitting smoking. Regardless of the group participants are assigned to, they will also receive a combination of nicotine replacement therapy (patches and gums) that have been shown to help people quit smoking. The main questions this study aims to answer are: Participants will complete 5 video call visits over about 6 months. Participants will install their assigned smoking cessation app onto their phone and will be asked to use the app for the duration of the study along with their provided Nicotine Replacement Therapy (NRT) products. During the study visits, participants will meet with study staff to complete questionnaires and interviews. Participants may be asked to provide breath and saliva samples to measure the level of carbon monoxide and nicotine.

Targeting Lifestyle to Improve Colorectal Cancer Screening

The goal of this study is to learn whether receiving personalized, digital lifestyle advice during colorectal cancer screening leeds to changes in lifestyle over a two-year follow-up period. Changes will be measured using a composite score including diet, alcohol consumption, physical activity, body mass index and smoking habits. The main questions it aims to answer are: * Do participants who receive short, personalized digital feedback on their lifestyle - either once or through repeated rounds -change their lifestyle during the two-year study period, compared to those who do not receive any feedback? * Does the inclusion of additional contact, such as telephone consultation with healthcare providers, result in further lifestyle changes? Researchers will compare three groups which receive digital feedback at different intensities and a control group which does not get any feedback to see if lifestyle changes differ between the groups. Participants in four different groups will fill in a digital diet and lifestyle questionnaire at the start of the study and 2-4 times after this during the following 2 years. * Participants in three of the groups will receive a short digital feedback report on their lifestyle related to health recommendations after each completion of the questionnaire. * One of these groups will also be offered to go through the feedback report together with a healthcare provider in a telephone call. * This group will also receive invitations to motivational webinars every half year during the 2-year study period. The topics in the webinars address cancer preventive lifestyle. A secondary goal of the study is to understand whether the invitation to fill in the diet and lifestyle questionnaire affects participation in colorectal cancer screening. Therefore, a fifth group of individuals invited to colorectal cancer screening but not to be invited to fill in the questionnaire will be included for extra comparison. Participation in colorectal cancer screening will be compared between this group and the four groups that are additionally invited to complete the questionnaire. Another secondary goal is to learn which groups in the society consent to the current study. Therefore, sociodemographic characteristics will be compared between the invited individuals who consent and those who do not consent to the study.

Understanding Vape Marketing Study

The purpose of this study is to develop an electronic cigarette (e-cigarette) counter-marketing lesson for adolescents. The lesson will involve short videos designed to improve adolescents' cognition of e-cigarette marketing in the retail environment with the overall goal of reducing their susceptibility to use, intent to use, and actual use of e-cigarettes. Through this study, the study team will identify and refine the key messages that would make this lesson acceptable, feasible to implement, and effective in altering e-cigarette-related perceptions and potentially behaviors.

Secondhand Smoke Respiratory Health Study

Exposure to secondhand tobacco smoke (SHS) is associated with diverse health effects in nonsmokers. Flight attendants (FA) who worked on commercial aircraft before the ban on tobacco smoking (exposed FAs) had high, long-term levels of occupational exposure to SHS and are a unique population for the study of long-term health effects of chronic exposure to SHS. In previous studies, we have shown that many never-smoking SHS-exposed FAs to have curvilinear flow-volume loops, decreased airflow at mid- and low-lung volumes, and static air trapping (elevated residual volume to total lung capacity ratio \[RV/TLC\]), abnormalities that are not diagnostic of overt Chronic Obstructive Pulmonary Disease (COPD), but do implicate the presence of an obstructive ventilatory defect, and are consistent with what has been recently described as preserved ratio impaired spirometry (PRISm). The main objective of the study is to determine the effect of a bronchodilator to counter the physiologic abnormalities that are observed in the population of never-smoking SHS-exposed FAs as both proof of concept of the presence of an obstructive lung disease and as a possible therapeutic option to counteract the adverse respiratory effects of chronic exposure to SHS.