Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT03962660
Brief Summary:
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.
Detailed Description:
The prevalence of smoking and smoking-related illness is disproportionately higher among people experiencing chronic homelessness than among people in the general population. Unfortunately, smoking cessation treatment does not reach or engage the overwhelming majority of smokers experiencing chronic homelessness, and smoking-related harm persists even after people are housed. There have therefore been calls for more flexible and client-centered approaches tailored to this population's needs. In response, we are proposing a randomized controlled trial (RCT) of Harm-Reduction for Tobacco Smoking with support of Tobacco-Replacing Electronic Nicotine Delivery Systems (HaRTS-TRENDS) as an innovative, empirically informed, and client-driven alternative to traditional smoking cessation treatment. To maximize its efficacy, the 4-session, individual HaRTS-TRENDS was collaboratively designed with a community advisory board made up of researchers, people with lived experience of chronic homelessness and smoking, and staff and management at a nonprofit, community-based housing agency. HaRTS-TRENDS entails the provision of electronic nicotine delivery systems (ENDS) in conjunction with harm-reduction counseling. Interventionists embody a compassionate, advocacy-oriented "heart-set" or style and deliver manualized components that include 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. The proposed study will feature a randomized controlled trial (N=94) of HaRTS-TRENDS among smokers with lived experience of chronic homelessness who have moved into permanent, supportive housing. Participants will be randomized to receive HaRTS-TRENDS or standard care. The standard care, which is what people most commonly receive from providers, is brief advice to quit plus referral to the Washington State quitline where participants have access to free NRT. All participants will be assessed at baseline and posttest as well as at 1-, 3-, 6-, and 12-month follow-ups. Analyses will be conducted to test the efficacy of HaRTS-TRENDS compared to SC in a) facilitating biochemically verified nonsmoking and b) reducing smoking-related harm as measured by concentration of urinary tobacco-specific nitrosamines (TSNAs). It is hypothesized that, compared to SC participants, HaRTS-TRENDS participants will show a significantly greater likelihood of nonsmoking and reduced concentration of TSNAs. Further, we will examine reductions in smoking craving as a mediator of the HaRTS-TRENDS effect on nonsmoking as well as nonsmoking as a mediator of the HaRTS-TRENDS effect on TSNA concentration. If its results are positive, this project will lay the groundwork for longer-term objectives including dissemination of HaRTS-TRENDS to researchers, clinicians, and community-based agencies to decrease smoking-related harm for a high-cost and severely affected population.
Study:
NCT03962660
Study Brief:
Protocol Section:
NCT03962660