Harm Reduction for Tobacco Smoking With Support of Tobacco-Replacing Electronic Nicotine Delivery Systems (HaRTS-TRENDS)
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|ClinicalTrials.gov Identifier: NCT03962660|
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking, Tobacco||Other: HaRTS-TRENDS Other: Standard Care (SC)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
HaRTS-TRENDS, in which participants will attend 4, 30-minute sessions with research staff. They will discuss participants' current smoking and their goals around reducing smoking-related harm and improving their health-related quality of life. Participants will also engage in discussions about the safety profiles of different nicotine products. One group of these products, e-cigarettes, is 95% safer than smoking and will be made available to participants to help them achieve their harm-reduction goals. They will receive instructions and demonstrations for its safe and proper use.
Standard care, in which will attend 4, 30-minute sessions of brief advice to quit.
|Official Title:||Randomized Controlled Trial of Harm Reduction for Tobacco Smoking With Support of Tobacco-Replacing Electronic Nicotine Delivery Systems (HaRTS-TRENDS)|
|Actual Study Start Date :||May 9, 2019|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
See description below.
HaRTS-TRENDS comprises 4, individual sessions delivered in the context of the interventionist's pragmatic harm-reduction mindset paired with a compassionate, advocacy-oriented "heart-set" or style. It comprises the delivery of 4 manualized components, including a) participant-led tracking of preferred smoking outcomes, b) elicitation of participants' harm-reduction goals and their progress toward achieving them, c) discussion of the relative risks of various nicotine delivery systems, and d) instruction in using ENDS. Additionally, HaRTS-TRENDS entails provision of commercially available ENDS.
Active Comparator: Standard Care (SC)
See description below.
Other: Standard Care (SC)
The 4-session, individual standard care control condition entails the well-documented and evidence-based 5 As intervention (i.e., Ask about nicotine use, Assess use, Advise to quit smoking, Assist with exploring current smoking/planning smoking cessation, Arrange follow-up). Part of arranging follow-up is the recommendation to call the smoking quit line, which can supply additional counseling and nicotine replacement therapy.
Other Name: 5 As
- Nonsmoking [ Time Frame: Change across the 12-month follow-up ]Biologically verified nonsmoking (i.e., self-reported nonsmoking if corresponding CO measure is < 8) in the past 7 days will serve as a primary outcome as well as a potential mediator of the HaRTS-TRENDS effect on TSNA concentration.
- TSNA Concentration [ Time Frame: Change across the 12-month follow-up ]This primary outcome entails urinary concentration of a tobacco-specific nitrosamine (i.e., NNK), a key carcinogen in tobacco. Secondarily, TSNA concentration will be used as a longer-term biochemical index of tobacco use.
- smoking intensity [ Time Frame: Change across the 12-month follow-up ]Self-reported smoking intensity is the mean number of cigarettes participants report smoking per day in the 7 days prior to the assessment.
- smoking frequency [ Time Frame: Change across the 12-month follow-up ]Self-reported smoking frequency is the number of days participants report smoking in the 7 days prior to the assessment.
- CO level [ Time Frame: Change across the 12-month follow-up ]Carbon monoxide in exhaled air will be examined secondarily as a continuous measure of reduced smoking-related harm. It will also be used to biochemically verify the 7-day nonsmoking primary outcome.
- cotinine levels [ Time Frame: Change across the 12-month follow-up ]Urinary cotinine will reflect participants' recent nicotine use.
- FEV1% [ Time Frame: Change across the 12-month follow-up ]FEV1% is the ratio of predicted lung capacity based on participants' height, age and gender with participants' forced expiratory volume in the first second of expiration as a percentage of the predicted value.
- Clinical COPD questionnaire [ Time Frame: Change across the 12-month follow-up ]The 10-item Clinical COPD Questionnaire will be used to calculate an overall summary score representing respiratory HR-QoL over 3 domains: respiratory symptoms (e.g., shortness of breath), functional state (e.g., ability to climb stairs), and mental state (i.e., concern about getting a cold or breathing getting worse). The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse HRQoL.
- EQ-5D-5L [ Time Frame: Change across the 12-month follow-up ]This self-report measure yields 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Additionally, the EuroQoL-Visual Analog Scale (EQ-VAS) is a single item representing health-related quality of life via participants' general assessments of their current health, where 0 = the worst health imaginable and 100 = the best health imaginable.
- smoking craving [ Time Frame: Change across the 12-month follow-up ]Smoking craving is a potential mediator of the proposed intervention effects and will be measured using the Questionnaire for Smoking Urges-Brief (QSU-B) consists of 10 items rated on 7-point Likert scales ranging from 0 (strongly disagree) to 6 (strongly agree). Changes in smoking craving summary scores will be tested as a mediator of the HaRTS-TRENDS effects on complete switchover.
- side effects of ENDS [ Time Frame: Change across the 12-month follow-up ]We will assess participants' experience of known, ENDS-related adverse events (i.e., dry mouth, throat irritation, short-ness of breath, headache, cough, tachycardia, nausea) using a 5-item, 5-point Likert-type questionnaire (ranging from 0=none to 5=severe) that was adapted from the Systematic Assessment for Treatment Emergent Effects (SAFTEE) interview.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962660
|Contact: Tatiana M Ubayfirstname.lastname@example.org|
|Contact: Emily Tayloremail@example.com|
|United States, Washington|
|University of Washington - Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Susan E Collins, PhD 206-832-7885 firstname.lastname@example.org|
|Principal Investigator: Susan E Collins, PhD|
|Principal Investigator:||Susan E Collins, PhD||University of Washington|