Smoking, Tobacco Clinical Trial
— HaRTS-TRENDSOfficial title:
Randomized Controlled Trial of Harm Reduction for Tobacco Smoking With Support of Tobacco-Replacing Electronic Nicotine Delivery Systems (HaRTS-TRENDS)
This study will evaluate the effectiveness of HaRTS-TRENDS compared to standard care (i.e., brief advice to quit + referral to state quit line that offers free NRT) in facilitating a biochemically verified nonsmoking and b) reducing smoking-related harm as measured by concentration of urinary tobacco-specific nitrosamines (TSNAs). Potential underlying mechanisms of changes in the proposed outcomes--including nicotine craving and smoking reduction, respectively--will be tested.
Status | Recruiting |
Enrollment | 94 |
Est. completion date | December 31, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Having a history of chronic homelessness according to the widely accepted federal definition, - Being a current DESC client living in one of DESC's participating permanent supportive housing projects, - Being between 21-65 years of age, - Being a daily smoker (>4 cigarettes/day in the past year with a breath CO = 6 ppm or salivary cotinine test at level 1 if CO < 6 ppm) - Having adequate English language skills to understand verbal information and communicate in the study Exclusion Criteria: - Use of other tobacco products besides cigarettes = 9 days in the past month - Refusal or inability to consent to participation in research - Constituting a risk to the safety and security of other clients or staff. |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington - Harborview Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Downtown Emergency Service Center, Washington State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | smoking craving | 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. | Change across the 12-month follow-up | |
Other | side effects of ENDS | 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. | Change across the 12-month follow-up | |
Primary | Nonsmoking | 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. | Change across the 12-month follow-up | |
Primary | TSNA Concentration | 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. | Change across the 12-month follow-up | |
Secondary | smoking intensity | Self-reported smoking intensity is the mean number of cigarettes participants report smoking per day in the 7 days prior to the assessment. | Change across the 12-month follow-up | |
Secondary | smoking frequency | Self-reported smoking frequency is the number of days participants report smoking in the 7 days prior to the assessment. | Change across the 12-month follow-up | |
Secondary | CO level | 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. | Change across the 12-month follow-up | |
Secondary | cotinine levels | Urinary cotinine will reflect participants' recent nicotine use. | Change across the 12-month follow-up | |
Secondary | FEV1% | 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. | Change across the 12-month follow-up | |
Secondary | Clinical COPD questionnaire | 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. | Change across the 12-month follow-up | |
Secondary | EQ-5D-5L | 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. | Change across the 12-month follow-up |
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