Nicotine Dependence, CigarettesNCT04379388
Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults
A study testing Web + text smoking cessation intervention in people with Nicotine Dependence, Cigarettes, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of this study is to understand how to develop and deliver a better smoking cessation program for lower-income young adult smokers. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Cigarettes
- What is being tested?
- Web + text smoking cessation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2020to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-30
- lives in the U.S.
- smoked at least 100 lifetime cigarettes
- currently smokes every day or some days
- interest in quitting smoking within the next 6 months
- subjective financial situation of just meeting or not meeting basic expenses
- access to a smartphone with internet
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to understand how to develop and deliver a better smoking cessation program for lower-income young adult smokers.
Read the detailed description
Using content and strategy developed from the formative research phase, this randomized smoking cessation trial will test the impact of a tailored cessation intervention for socioeconomically-disadvantaged young adult (SDYA) smokers compared to a usual-care control on intervention engagement, self-efficacy to quit, and 30-day point prevalence abstinence at 3-month follow-up.
This study will take place over a 3-month period. Individuals who complete the screening survey and are eligible to participate will be asked to complete a 15-20 minute baseline survey at the start of the study. This survey will ask questions about use of mobile phones, tobacco use, recent alcohol and other drug use, concerns about the coronavirus outbreak and how it may affect personal tobacco use, and physical activity. After the first survey, participants will be assigned randomly to one of two study groups:
Group A: Referral to a quit smoking hotline (quit line)
Group B: Referral to a quit smoking hotline (quit line), plus enrollment in a web and text-based smoking cessation intervention.
Participants in both groups will be enrolled after completing the following steps, in order:
- Providing consent to participate in the study;
- Confirming contact information;
- Completing a payment acknowledgement form that allows us to reimburse for survey/task completions; and
- Completing the baseline survey.
To complete enrollment, participants in Group B will also be required to register for an account on BecomeAnEx.org and enroll in text messages on the site. Once registered, Group B participants will be enrolled in a text message program customized for this study and will need to respond to the initial message from the text message platform to initiate text messages.
Participants in Group B will receive daily text messages for 3 months with content delivered through the Truth Initiative's BecomeAnEx digital quit smoking platform. They will also receive brief (1-2 minute) weekly check-in surveys related to the week's messages and smoking status during this time.
At 3-months, participants in both groups will receive the 15-minute follow-up assessment. Participants in both groups who report quitting smoking at 3-months will be mailed a kit in order to take a saliva test to measure the amount of cotinine, a metabolite of nicotine, in their saliva. Participants who report smoking at the 3-month follow-up will not receive this saliva test.
All study procedures will take place remotely, with surveys conducted online. Participants in Group A will be paid at least $30 for participation and up to $80. Participants in Group B will be paid at least $40 for participation and up to $170.
- Conditions
- Nicotine Dependence, Cigarettes
- Being tested
- Web + text smoking cessation intervention
- Keywords
- smoking, smoking cessation, nicotine, nicotine dependence
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web + text smoking cessation interventionBehavioural
Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention
| Study group | Role | What they receive |
|---|---|---|
| Web + text smoking cessation intervention | Experimental | Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention Receives: Behavioral: Web + text smoking cessation intervention |
| Usual care control | No intervention | Participants will receive referral to a quit smoking hotline |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day point prevalence smoking abstinence
Self-reported smoking abstinence and biochemical validation (saliva cotinine)
Measured: Assessed at 3-month follow-up
Self-efficacy to quit smoking
Confidence to quit within the next month (7days) on 0-10 scale
Measured: Assessed at 3-month follow-up
Intervention engagement
Completing 75% or more of 12 weekly check-ins
Measured: 12 weeks
Secondary outcomes (4)
7-day point prevalence smoking abstinence
Self-reported smoking abstinence
Measured: Assessed at 3-month follow-up
Number of 24-hour quit attempts
Number of times intentionally stopped smoking cigarettes for 24 hours or longer because trying to quit
Measured: Assessed at 3-month follow-up
Perceived support to quit smoking
4 items pertaining to quit support from the text messages
Measured: Assessed 3-month follow-up
Pattern and rate of tobacco/e-cigarette use
Past 30 (90 day) use of tobacco or nicotine products such as cigars, e-cigarettes, chewing tobacco, and nicotine replacement products
Measured: Assessed at 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start21 Apr 2020
- Primary completion1 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Dependence, CigarettesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Andrea Villanti, University of Vermont
- Investigators
- Andrea C Villanti, PhD, MPH, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379388
- Sponsor's protocol ID
- 17-0351
- Other IDs
- P20GM103644
- Status last verified
- Feb 2021
- First submitted
- 24 Apr 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults
- ClinicalTrials.gov ID
- NCT04379388
- Acronym / sponsor ID
- 17-0351
- Conditions
- Nicotine Dependence, Cigarettes
- Keywords
- smoking, smoking cessation, nicotine, nicotine dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand how to develop and deliver a better smoking cessation program for lower-income young adult smokers.
Detailed description
Using content and strategy developed from the formative research phase, this randomized smoking cessation trial will test the impact of a tailored cessation intervention for socioeconomically-disadvantaged young adult (SDYA) smokers compared to a usual-care control on intervention engagement, self-efficacy to quit, and 30-day point prevalence abstinence at 3-month follow-up.
This study will take place over a 3-month period. Individuals who complete the screening survey and are eligible to participate will be asked to complete a 15-20 minute baseline survey at the start of the study. This survey will ask questions about use of mobile phones, tobacco use, recent alcohol and other drug use, concerns about the coronavirus outbreak and how it may affect personal tobacco use, and physical activity. After the first survey, participants will be assigned randomly to one of two study groups:
Group A: Referral to a quit smoking hotline (quit line)
Group B: Referral to a quit smoking hotline (quit line), plus enrollment in a web and text-based smoking cessation intervention.
Participants in both groups will be enrolled after completing the following steps, in order:
- Providing consent to participate in the study;
- Confirming contact information;
- Completing a payment acknowledgement form that allows us to reimburse for survey/task completions; and
- Completing the baseline survey.
To complete enrollment, participants in Group B will also be required to register for an account on BecomeAnEx.org and enroll in text messages on the site. Once registered, Group B participants will be enrolled in a text message program customized for this study and will need to respond to the initial message from the text message platform to initiate text messages.
Participants in Group B will receive daily text messages for 3 months with content delivered through the Truth Initiative's BecomeAnEx digital quit smoking platform. They will also receive brief (1-2 minute) weekly check-in surveys related to the week's messages and smoking status during this time.
At 3-months, participants in both groups will receive the 15-minute follow-up assessment. Participants in both groups who report quitting smoking at 3-months will be mailed a kit in order to take a saliva test to measure the amount of cotinine, a metabolite of nicotine, in their saliva. Participants who report smoking at the 3-month follow-up will not receive this saliva test.
All study procedures will take place remotely, with surveys conducted online. Participants in Group A will be paid at least $30 for participation and up to $80. Participants in Group B will be paid at least $40 for participation and up to $170.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web + text smoking cessation intervention | Experimental | Behavioral: Web + text smoking cessation interventionParticipants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention |
| Usual care control | No intervention | –Participants will receive referral to a quit smoking hotline |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age 18-30
- lives in the U.S.
- smoked at least 100 lifetime cigarettes
- currently smokes every day or some days
- interest in quitting smoking within the next 6 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Web + text smoking cessation interventionParticipants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention | Behavioural | Web + text smoking cessation intervention |
Primary outcome
30-day point prevalence smoking abstinence
Time frame: Assessed at 3-month follow-up
Self-reported smoking abstinence and biochemical validation (saliva cotinine)
Self-efficacy to quit smoking
Time frame: Assessed at 3-month follow-up
Confidence to quit within the next month (7days) on 0-10 scale
Intervention engagement
Time frame: 12 weeks
Completing 75% or more of 12 weekly check-ins
4 secondary outcomes
7-day point prevalence smoking abstinence
Time frame: Assessed at 3-month follow-up
Number of 24-hour quit attempts
Time frame: Assessed at 3-month follow-up
Perceived support to quit smoking
Time frame: Assessed 3-month follow-up
Pattern and rate of tobacco/e-cigarette use
Time frame: Assessed at 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Andrea C Villanti, PhD, MPH principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web + text smoking cessation intervention in people with Nicotine Dependence, Cigarettes, run by University of Vermont 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 7 inclusion and 0 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 11 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30-day point prevalence smoking abstinence (time frame: Assessed at 3-month follow-up). The study lists 3 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 11 Feb 2021.