Harm Reduction for Tobacco Smoking With Support of Tobacco-Replacing Electronic Nicotine Delivery Systems

NCT03962660 | Unknown DMC

• 1 other identifier: STUDY00006430
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• smoking intensity

  Change across the 12-month follow-up

• smoking frequency

  Change across the 12-month follow-up

• CO level

  Change across the 12-month follow-up

• cotinine levels

  Change across the 12-month follow-up

• FEV1%

  Change across the 12-month follow-up

Other Outcomes (2)

• smoking craving

  Change across the 12-month follow-up

• side effects of ENDS

  Change across the 12-month follow-up

Study Arms (2)

HaRTS-TRENDS

EXPERIMENTAL

See description below.

Other: HaRTS-TRENDS

Standard Care (SC)

ACTIVE COMPARATOR

See description below.

Other: Standard Care (SC)

Interventions

HaRTS-TRENDS OTHER

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.

HaRTS-TRENDS

Standard Care (SC) OTHER

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.

Also known as: 5 As

Standard Care (SC)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Downtown Emergency Service Center: collaborator
• Washington State University: collaborator

Study Sites (1)

University of Washington - Harborview Medical Center

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Smoking

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Susan E Collins, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana M Ubay

CONTACT

206-744-9913; tatiubay@uw.edu

Emily Taylor

CONTACT

206-744-1873; emt07@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 24, 2019
• Study Start: May 9, 2019
• Primary Completion: April 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)