Smoking CessationNCT04075682
Cigarette Pack Inserts for Smoking Cessation
A study testing Inserts with efficacy messages and Pictorial warnings on packs in people with Smoking Cessation, run by University of South Carolina at 2 sites in United States.
Trial summary
This study will test whether cigarette package inserts (i.e., small printed leaflets inside cigarette packs) with messages about the benefits of cessation and tips for quitting can help smokers quit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Inserts with efficacy messages and Pictorial warnings on packs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2019to 29 Jun 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 or older
- Have smoked at least 100 cigarettes in their lifetime
- Smoked at least 10 cigarettes a day in the prior month.
Who cannot join
- Use of other nicotine products besides cigarettes in the prior month.
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of South Carolina
Columbia, South Carolina, 29208
Cornell University
Ithaca, New York, 14853
About this study
Official title: Evaluation of Cigarette Package Inserts for Enhanced Communication With Smokers
This study will test whether cigarette package inserts (i.e., small printed leaflets inside cigarette packs) with messages about the benefits of cessation and tips for quitting can help smokers quit. To do this, the investigators will conduct a 2 X 2 between-subject experiment in which 380 smokers will be randomized into one of four labeling groups: 1. no inserts or pictorial health warning labels (HWLs); 2. inserts only; 3. pictorial HWLs only; 4. inserts \& pictorial HWLs. Smokers will be given a 14-day supply of their preferred cigarette brand with packs labeled according to their experimental group. Participants will answer a brief survey at the end of each day and four other times each day, using ecological momentary assessment approaches. The investigators will study whether smokers in each group experience different psychological responses and behaviors associated with smoking cessation.
- Conditions
- Smoking Cessation
- Being tested
- Inserts with efficacy messages, Pictorial warnings on packs
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inserts with efficacy messagesOther
Four rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs.
Pictorial warnings on packsOther
Four rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs.
| Study group | Role | What they receive |
|---|---|---|
| Standard cigarette packs (control) | No intervention | Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with the only alteration being the small health warning message on the side of the pack, whose textual content will be the same as that used for the pictorial warning label conditions. |
| Cigarette packs with inserts only | Experimental | Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four different rotating messages to promote response efficacy beliefs (2 inserts on the benefits of cessation) or self-efficacy to quit (2 inserts with cessation tips). Receives: Other: Inserts with efficacy messages |
| Cigarette packs with pictorial warnings only | Experimental | Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include four different rotating pictorial warnings showing the consequences of smoking and that cover 50% of the front and back of the pack. Receives: Other: Pictorial warnings on packs |
| Cigarette packs with inserts and pictorial warnings | Experimental | Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four rotating efficacy messages (see description above) and four rotating pictorial warnings (see above). Receives: Other: Inserts with efficacy messages; Other: Pictorial warnings on packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy to Quit Smoking
A single question measured on a continuous scale (1="Not at all", worse outcome; 7="Extremely", better outcome) to assess strength of confidence to quit smoking, with average scores (range 1-7) estimated.
Measured: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Self-efficacy to Cut Down on Smoking
A single question measured on a continuous scale (1="Not at all", worse outcome; 7="Extremely", better outcome) to assess strength of confidence to cut down on the number of cigarettes smoked, with average scores (range=1-7) estimated.
Measured: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Worry About Harms From Smoking
A single question measured on a continuous scale to assess strength of worry about harms from smoking (1="Not at all", worse outcome; 7="Extremely", better outcome), with average scores (range=1-7) estimated.
Measured: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Strength of Feeling About Smoking
A single question measured on a continuous scale to assess strength of positive to negative feelings about smoking (1="very bad", better outcome; 7="very good", worse outcome), with average scores (range=1-7) estimated
Measured: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Extent of Motivation to Quit Smoking
A single question measured on a continuous scale to assess the extent of motivation to quit smoking (1="Not at all", worse outcome; 7="Extremely", better outcome), with average scores (range=1-7) estimated.
Measured: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Talk About Smoking Cessation
For each day, a single binary variable was derived to indicate whether the participant talked about either smoking cessation or smoking-related harms in the prior 24 hours, with the average daily percentage of this outcome estimated. Experiencing the event of talking about cessation or harms is a better outcome, as it is a predictor of cessation attempts.
Measured: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Foregoing a Cigarette
For each day, responses to two questions were combined to create a binary variable for whether, in the prior 24 hours, the participant a) did not smoke a cigarette when they normally would, and/or b) stubbed out a cigarette before finishing it, with the average daily percentage of this outcome estimated. Experiencing the event of forgoing/stubbing out is a better outcome, as it is a predictor of cessation attempts.
Measured: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Secondary outcomes (9)
Strength of Hopefulness About Quitting
A single question measured on a continuous scale to assess strength of feeling hopeful about quitting (1="Not at all", worse outcome; 7="Extremely", better outcome), with average scores (range 1-7) estimated.
Measured: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Extent of Cognitive Elaboration of Smoking Benefits
A single question measured on a continuous scale to assess the frequency of thinking about the positive things about smoking (1="Not at all", better outcome; 7="Extremely", worse outcome), with average scores (range 1-7) estimated.
Measured: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Extent of Cognitive Elaboration of Smoking Harms
A single question measured on a continuous scale to assess the frequency of thinking about the harms from smoking (1="Not at all", worse outcome; 7="Extremely", better outcome), with average scores (range 1-7) estimated.
Measured: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Extent of Cognitive Elaboration of Cessation Benefits
A single question measured on a continuous scale to assess the frequency of thinking about the potential benefits from cessation (1="Not at all", worse outcome; 7="Extremely", better outcome), with average scores (range 1-7) estimated.
Measured: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Strength of Beliefs About Benefits of Smoking Cessation (i.e., Response Efficacy)
A single question measured on a continuous scale to assess the strength of perceived benefits from cessation (1="Not at all", worse outcome; 7="Extremely", better outcome), with average scores (range 1-7) estimated.
Measured: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Strength of Perceived Susceptibility to Smoking Harms
A single question measured on a continuous scale to assess the perceived likelihood of suffering harms from smoking (1="Not at all", worse outcome; 7="Extremely", better outcome), with average scores (range 1-7) estimated.
Measured: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Expressed Reactance Against Health Messages
- Binary measure for whether the participant reported talking about how health information on packs is either useless or not believable in the prior 24 hours, with the average daily percentage of this outcome estimated. Experiencing the event is a worse outcome, as it suggests defensive responding to labels.
Measured: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Satisfaction From Smoking
Single question measured on a continuous scale that assesses strength of satisfaction from smoking (1="Not at all", better outcome; 7="Extremely", worse outcome), with average scores (range 1-7) estimated.
Measured: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Cigarettes Logged
Continuous variable summing the total number of cigarettes logged over the study period. Lower values represent a better outcome (i.e., fewer cigarettes smoked).
Measured: Participants logged each cigarette smoked over the 14 day study period, with analyses limited to reports from days 2-14. Day 1 and 15 were dropped due to varying coverage of the day depending on study orientation time (Day 1) and ending (Day 15).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start1 Aug 2019
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- In a 2 X 2 between subject design, smokers will be randomized into one of four cigarette package labeling conditions: 1. no inserts or pictorial HWLs; 2. inserts only; 3. pictorial HWLs only; 4. inserts \& pictorial HWLs
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, University of Waterloo, University of Tasmania
- Responsible party
- Principal investigator, James Francis Thrasher, PhD, University of South Carolina
- Investigators
- James F Thrasher, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075682
- Sponsor's protocol ID
- Pro00083728
- Status last verified
- Nov 2023
- First submitted
- 20 Aug 2019
- Last updated
- 13 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are likely to make participant data to researchers who make specific requests and have specific data analysis plans that we approve.
Publications
Cruz-Jimenez L, Thrasher JF, Lambert VC, Leal DF, Davis RE, Yang CH. Associations of egocentric social network characteristics with conversations about the harms of smoking and the benefits of quitting. PLoS One. 2026 Jul 22;21(7):e0344453. doi: 10.1371/journal.pone.0344453. eCollection 2026.
PubMed 42485420
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cigarette Package Inserts for Enhanced Communication With Smokers
- ClinicalTrials.gov ID
- NCT04075682
- Acronym / sponsor ID
- Pro00083728
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Cornell University, University of Waterloo, University of Tasmania
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Posted 13 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether cigarette package inserts (i.e., small printed leaflets inside cigarette packs) with messages about the benefits of cessation and tips for quitting can help smokers quit. To do this, the investigators will conduct a 2 X 2 between-subject experiment in which 380 smokers will be randomized into one of four labeling groups: 1. no inserts or pictorial health warning labels (HWLs); 2. inserts only; 3. pictorial HWLs only; 4. inserts \& pictorial HWLs. Smokers will be given a 14-day supply of their preferred cigarette brand with packs labeled according to their experimental group. Participants will answer a brief survey at the end of each day and four other times each day, using ecological momentary assessment approaches. The investigators will study whether smokers in each group experience different psychological responses and behaviors associated with smoking cessation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- In a 2 X 2 between subject design, smokers will be randomized into one of four cigarette package labeling conditions: 1. no inserts or pictorial HWLs; 2. inserts only; 3. pictorial HWLs only; 4. inserts \& pictorial HWLs
| Arm | Type | Receives |
|---|---|---|
| Standard cigarette packs (control) | No intervention | –Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with the only alteration being the small health warning message on the side of the pack, whose textual content will be the same as that used for the pictorial warning label conditions. |
| Cigarette packs with inserts only | Experimental | Other: Inserts with efficacy messagesParticipants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four different rotating messages to promote response efficacy beliefs (2 inserts on the benefits of cessation) or self-efficacy to quit (2 inserts with cessation tips). |
| Cigarette packs with pictorial warnings only | Experimental | Other: Pictorial warnings on packsParticipants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include four different rotating pictorial warnings showing the consequences of smoking and that cover 50% of the front and back of the pack. |
| Cigarette packs with inserts and pictorial warnings | Experimental | Other: Inserts with efficacy messages, Other: Pictorial warnings on packsParticipants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four rotating efficacy messages (see description above) and four rotating pictorial warnings (see above). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 or older
- Have smoked at least 100 cigarettes in their lifetime
- Smoked at least 10 cigarettes a day in the prior month.
Key exclusion criteria (2 listed)
- Use of other nicotine products besides cigarettes in the prior month.
- Pregnant women
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 |
|---|---|---|
| Inserts with efficacy messagesFour rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs. | Other | Cigarette packs with inserts and pictorial warnings, Cigarette packs with inserts only |
| Pictorial warnings on packsFour rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs. | Other | Cigarette packs with inserts and pictorial warnings, Cigarette packs with pictorial warnings only |
Primary outcome
Self-efficacy to Quit Smoking
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
A single question measured on a continuous scale (1="Not at all", worse outcome; 7="Extremely", better outcome) to assess strength of confidence to quit smoking, with average scores (range 1-7) estimated.
Self-efficacy to Cut Down on Smoking
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
A single question measured on a continuous scale (1="Not at all", worse outcome; 7="Extremely", better outcome) to assess strength of confidence to cut down on the number of cigarettes smoked, with average scores (range=1-7) estimated.
Worry About Harms From Smoking
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
A single question measured on a continuous scale to assess strength of worry about harms from smoking (1="Not at all", worse outcome; 7="Extremely", better outcome), with average scores (range=1-7) estimated.
Strength of Feeling About Smoking
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
A single question measured on a continuous scale to assess strength of positive to negative feelings about smoking (1="very bad", better outcome; 7="very good", worse outcome), with average scores (range=1-7) estimated
Extent of Motivation to Quit Smoking
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
A single question measured on a continuous scale to assess the extent of motivation to quit smoking (1="Not at all", worse outcome; 7="Extremely", better outcome), with average scores (range=1-7) estimated.
Talk About Smoking Cessation
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
For each day, a single binary variable was derived to indicate whether the participant talked about either smoking cessation or smoking-related harms in the prior 24 hours, with the average daily percentage of this outcome estimated. Experiencing the event of talking about cessation or harms is a better outcome, as it is a predictor of cessation attempts.
Foregoing a Cigarette
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
For each day, responses to two questions were combined to create a binary variable for whether, in the prior 24 hours, the participant a) did not smoke a cigarette when they normally would, and/or b) stubbed out a cigarette before finishing it, with the average daily percentage of this outcome estimated. Experiencing the event of forgoing/stubbing out is a better outcome, as it is a predictor of cessation attempts.
9 secondary outcomes
Strength of Hopefulness About Quitting
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Extent of Cognitive Elaboration of Smoking Benefits
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Extent of Cognitive Elaboration of Smoking Harms
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Extent of Cognitive Elaboration of Cessation Benefits
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Strength of Beliefs About Benefits of Smoking Cessation (i.e., Response Efficacy)
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Strength of Perceived Susceptibility to Smoking Harms
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Expressed Reactance Against Health Messages
Time frame: Evaluated once each day (evening survey) over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying intervention exposure and coverage of the day, depending on study orientation time.
Satisfaction From Smoking
Time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.
Cigarettes Logged
Time frame: Participants logged each cigarette smoked over the 14 day study period, with analyses limited to reports from days 2-14. Day 1 and 15 were dropped due to varying coverage of the day depending on study orientation time (Day 1) and ending (Day 15).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42485420Cruz-Jimenez L, Thrasher JF, Lambert VC, Leal DF, Davis RE, Yang CH. Associations of egocentric social network characteristics with conversations about the harms of smoking and the benefits of quitting. PLoS One. 2026 Jul 22;21(7):e0344453. doi: 10.1371/journal.pone.0344453. eCollection 2026.
- Individual participant dataSharing planned: No. We are likely to make participant data to researchers who make specific requests and have specific data analysis plans that we approve.
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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.
James F Thrasher, PhD principal investigator
University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inserts with efficacy messages and Pictorial warnings on packs in people with Smoking Cessation, run by University of South Carolina at 2 sites 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 3 inclusion and 2 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 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 13 May 2024). 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?
Self-efficacy to Quit Smoking (time frame: Evaluated approximately 4-5 times a day over the 14 day study period, with analyses limited to days 2-14. Day 1 was dropped due to varying coverage of the day depending on study orientation time.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075682, which also lists 1 linked publication.
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 13 May 2024.