Clinical trial NCT03962660: Harm Reduction for Tobacco Smoking With Support of Tobacco-Replacing Electronic Nicotine Delivery Systems
Official title: Randomized Controlled Trial of Harm Reduction for Tobacco Smoking With Support of Tobacco-Replacing Electronic Nicotine Delivery Systems (HaRTS-TRENDS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking, Tobacco
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Downtown Emergency Service Center
name: Washington State University
First posted: 2019-05-24
Enrollment: 94
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.

-OR-

Standard care, in which will attend 4, 30-minute sessions of brief advice to quit.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nonsmoking
timeFrame: Change across the 12-month follow-up
measure: TSNA Concentration
timeFrame: Change across the 12-month follow-up
Secondary outcomes:
measure: smoking intensity
timeFrame: Change across the 12-month follow-up
measure: smoking frequency
timeFrame: Change across the 12-month follow-up
measure: CO level
timeFrame: Change across the 12-month follow-up
measure: cotinine levels
timeFrame: Change across the 12-month follow-up
measure: FEV1%
timeFrame: Change across the 12-month follow-up
measure: Clinical COPD questionnaire
timeFrame: Change across the 12-month follow-up
measure: EQ-5D-5L
timeFrame: Change across the 12-month follow-up
Other outcomes:
measure: smoking craving
timeFrame: Change across the 12-month follow-up
measure: side effects of ENDS
timeFrame: Change across the 12-month follow-up
Locations:
city: Seattle
country: United States
facility: University of Washington - Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Susan E Collins, PhD
role: PRINCIPAL_INVESTIGATOR
References: