Recruiting

Electronic Nicotine Delivery Systems

Sponsor:

University of Washington

Code:

NCT03962660

Conditions

Smoking, Tobacco

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

HaRTS-TRENDS

Standard Care (SC)

Study Details

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.

Conditions

Smoking, Tobacco

Study ID

NCT03962660

Start date

May 9, 2019

Status verified date

May, 2019

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Apr 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HaRTS-TRENDS

See description below.

active comparator: Standard Care (SC)

See description below.

Interventions

HaRTS-TRENDS

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.

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.

Primary outcome measure

  • Nonsmoking [ Time Frame: Change across the 12-month follow-up ]
  • TSNA Concentration [ Time Frame: Change across the 12-month follow-up ]

Central Contacts and Locations

Central contacts

Tatiana M Ubay

206-744-9913tatiubay@uw.edu

Emily Taylor

206-744-1873emt07@uw.edu

Locations

University of Washington - Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Susan E Collins, PhD

206-832-7885collinss@uw.edu

Principal Investigator:

Susan E Collins, PhD

More Information

Sponsor

University of Washington

Last update posted

May 24, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2019-05-24.