Clinical trial NCT03502200: Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures
Official title: Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Cigarette
Keywords: e-cigarettes
harm reduction
smoking behavior
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-04-18
Enrollment: 350
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two conditions randomly.
Primary purpose: PREVENTION

Brief summary: The overall aim of the study is to evaluate the provision of e-cigarette (EC) versus NRT on smoking behavior, product use patterns and continued use, and iCO, a biomarker of toxicant exposure, among a sample of recent QL treatment failures. We will randomly assign N=372 smokers (targeted accrual) to EC (n=186) or QL treatment as usual with combination nicotine replacement therapy (NRT; n=186). All participants will receive three calls from QL coaches and EC and NRT will be provided at no cost for 8 weeks. The final follow-up will occur 12-weeks post baseline.

Detailed description: There remains a lack of prospective and controlled research on the behavioral, toxicological, and physiological effects of electronic cigarettes (ECs) to help the public health community come to a clear and accurate consensus on their risk-benefit. In order to successfully execute the proposed study, the investigators plan to recruit and enroll recent smoking cessation treatment failures from a state QL, which predominately serves priority populations (e.g., low socioeconomic status, high levels of mental health conditions). The proposed study will randomly assign smokers who were recent QL treatment failures to a) EC (JUUL 5%) or b) QL treatment as usual with combination nicotine replacement therapy control (NRT).

Eligibility criteria: Inclusion Criteria:

* smoke ≥5 cigarettes per day for the past year
* read, write, and speak in English
* report at least minimal interest in switching to an alternative product (\> "not at all" on a Likert scale)
* participation in the Oklahoma Tobacco Helpline or South Carolina Tobacco Helpline within the last 4-7 months.

Exclusion Criteria:

* \<21 years old
* report NRT use or making a quit attempt within the last 7 days
* current daily use of an e-cigarette over last month.
* unstable or significant medical condition such as respiratory, kidney, or liver disease
* unstable or significant psychiatric conditions (past and stable conditions will be allowed)
* history of cardiac event or distress within the past 6 months
* currently pregnant, planning to become pregnant, or breastfeeding.
* currently enrolled in a contradictory study.
* cohabitates with a currently enrolled participant in the REACH study
* reaction to using patch medication or adhesive tape
* known allergy to propylene glycol or vegetable glycerin

Primary outcomes:
measure: Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes
timeFrame: Daily for 12 weeks
measure: Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence
timeFrame: 12 weeks
Secondary outcomes:
measure: Sociodemographic Questionnaire - Age
timeFrame: Baseline
measure: Sociodemographic Questionnaire - Sex
timeFrame: Baseline
measure: Sociodemographic Questionnaire - Marital Status
timeFrame: Baseline
measure: Sociodemographic Questionnaire - Ethnicity
timeFrame: Baseline
measure: Sociodemographic Questionnaire - Employment Status
timeFrame: Baseline
measure: Sociodemographic Questionnaire - Socioeconomic Status
timeFrame: Baseline
measure: Cigarette/EC Dependency Scale
timeFrame: 12 weeks
measure: Drug Effects/Liking Questionnaire
timeFrame: 12 weeks
measure: Cigarette Purchase Task - Breakpoint
timeFrame: Week 1 (Baseline)
measure: Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
timeFrame: 12 Weeks
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: 12 Weeks
measure: Change in Motivation Rulers (Scale) From Baseline to Week 12
timeFrame: 12 Weeks
Other outcomes:
measure: Tobacco Use History Questionnaire - Years of Smoking
timeFrame: Week 1 (baseline)
measure: Tobacco Use History Questionnaire - Cigarettes Per Day
timeFrame: Week 1 (baseline)
measure: Tobacco Use History Questionnaire - 24-hour Quit Attempts
timeFrame: Week 1 (baseline)
measure: Tobacco Use History Questionnaire - Number of Smokers in the Household
timeFrame: Week 1 (baseline)
measure: Tobacco Use History Questionnaire - Cigarette Expectance Effects
timeFrame: Week 1 (baseline)
measure: Tobacco Use History Questionnaire
timeFrame: Week 1 (Baseline)
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State Comprehensive Cancer Center
name: Theodore L Wagener, PhD
role: PRINCIPAL_INVESTIGATOR
References: