Smoking, CigaretteNCT03502200
Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures
A study testing JUUL and Treatment As Usual in people with Smoking, Cigarette, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette
- What is being tested?
- JUUL and Treatment As Usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- <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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failure
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.
Read the 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).
- Conditions
- Smoking, Cigarette
- Being tested
- JUUL, Treatment As Usual
- Keywords
- e-cigarettes, harm reduction, smoking behavior
- Medical subject headings
- Cigarette Smoking, Vaping, Harm Reduction, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUULDevice
Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.
Treatment As UsualOther
Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette | Experimental | 5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling. Receives: Device: JUUL |
| Treatment As Usual | Active comparator | Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes
Self-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.
Measured: Daily for 12 weeks
Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence
Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an iCO reading less than or equal to 8. A portable exhaled carbon monoxide detector confirms daily smoking status. Used to evaluate changes iCO, a biomarker of tobacco constituent exposure and other health effects.
Measured: 12 weeks
Secondary outcomes (12)
Sociodemographic Questionnaire - Age
Assess participant age from the sociodemographic questionnaire
Measured: Baseline
Sociodemographic Questionnaire - Sex
Assess participant sex from the sociodemographic questionnaire
Measured: Baseline
Sociodemographic Questionnaire - Marital Status
Assess participant marital status from the sociodemographic questionnaire
Measured: Baseline
Sociodemographic Questionnaire - Ethnicity
Assess participant ethnicity from the sociodemographic questionnaire
Measured: Baseline
Sociodemographic Questionnaire - Employment Status
Assess participant employment status from the sociodemographic questionnaire
Measured: Baseline
Sociodemographic Questionnaire - Socioeconomic Status
Assess participant socioeconomic status via yearly household income
Measured: Baseline
Cigarette/EC Dependency Scale
Assess e-cigarette and cigarette dependence.
Scores range from 5 to 25 with higher scores indicating a greater level of dependence.
Measured: 12 weeks
Drug Effects/Liking Questionnaire
Assess the desire and liking of products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness
Scores range from 1 to 5 with higher scores indicating greater strength (effect from smoking cigarettes/vaping e-cigarettes) or liking (liking of effect from smoking cigarettes/vaping e-cigarettes)
Measured: 12 weeks
Cigarette Purchase Task - Breakpoint
Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their own brand cigarette. Specifically they will be asked, "How much would you be willing to pay for a puff of your usual cigarette brand?".
Measured: Week 1 (Baseline)
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
Smoking and vaping urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form with a modified version (replacing the word "cigarette" with "e-cigarette") for EC users. This is a 10-item measure where participants rate smoking/vaping-related items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape.
Measured: 12 Weeks
Minnesota Nicotine Withdrawal Scale
Asses Nicotine withdrawal and smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing).
Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal (MNWS) or more craving to smoke (MNWS Craving).
Measured: 12 Weeks
Change in Motivation Rulers (Scale) From Baseline to Week 12
Assess for changes in motivation from baseline to week 12 among participants who continue to smoke. Rulers including importance, confidence, and readiness to quit smoking (3-items total, with a scale ranging from 0 "not at all important/confident/ready" to 10 "extremely important/confident/ready").
Medians reported are change from baseline [week 12 score - baseline score] where negative values indicate a decrease in motivation over time and positive values indicate an increase in motivation over time.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start15 Oct 2020
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two conditions randomly.
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Theodore Wagener, Ohio State University Comprehensive Cancer Center
- Investigators
- Theodore L Wagener, PhD, Principal investigator, Ohio State Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502200
- Sponsor's protocol ID
- OSU-19133
- Other IDs
- U01DA045537
- Status last verified
- Jun 2023
- First submitted
- 28 Feb 2018
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified and aggregated data will be shared through poster presentations and published manuscripts.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failure
- ClinicalTrials.gov ID
- NCT03502200
- Acronym / sponsor ID
- OSU-19133
- Conditions
- Smoking, Cigarette
- Keywords
- e-cigarettes, harm reduction, smoking behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 21 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two conditions randomly.
| Arm | Type | Receives |
|---|---|---|
| E-cigarette | Experimental | Device: JUUL5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling. |
| Treatment As Usual | Active comparator | Other: Treatment As UsualNicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- <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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUULParticipants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling. | Device | E-cigarette |
| Treatment As UsualNicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling. | Other | Treatment As Usual |
Primary outcome
Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes
Time frame: Daily for 12 weeks
Self-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.
Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence
Time frame: 12 weeks
Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an iCO reading less than or equal to 8. A portable exhaled carbon monoxide detector confirms daily smoking status. Used to evaluate changes iCO, a biomarker of tobacco constituent exposure and other health effects.
12 secondary outcomes
Sociodemographic Questionnaire - Age
Time frame: Baseline
Sociodemographic Questionnaire - Sex
Time frame: Baseline
Sociodemographic Questionnaire - Marital Status
Time frame: Baseline
Sociodemographic Questionnaire - Ethnicity
Time frame: Baseline
Sociodemographic Questionnaire - Employment Status
Time frame: Baseline
Sociodemographic Questionnaire - Socioeconomic Status
Time frame: Baseline
Cigarette/EC Dependency Scale
Time frame: 12 weeks
Drug Effects/Liking Questionnaire
Time frame: 12 weeks
Cigarette Purchase Task - Breakpoint
Time frame: Week 1 (Baseline)
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
Time frame: 12 Weeks
Minnesota Nicotine Withdrawal Scale
Time frame: 12 Weeks
Change in Motivation Rulers (Scale) From Baseline to Week 12
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. De-identified and aggregated data will be shared through poster presentations and published manuscripts.
Related trials for Smoking, Cigarette
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingPhase 3
iCanQuit Smoking Cessation Among Hispanic Adults
Cigarette Smoking-Related Carcinoma
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
Not yet recruiting
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Cigarette Smoking-Related Carcinoma
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore L Wagener, PhD principal investigator
Ohio State Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUUL and Treatment As Usual in people with Smoking, Cigarette, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes (time frame: Daily for 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.