SmokingNCT02247908
Impact of Graphic Cigarette Warnings
A study testing Surgeon General's Warning and Graphic Warning in people with Smoking, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
The purpose of this randomized controlled trial is to determine whether graphic health warnings on cigarette packs are more effective than the existing Surgeon General's warning on cigarette packs at encouraging quit attempts. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Surgeon General's Warning and Graphic Warning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,149 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Sep 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years or older
- Have smoked at least 100 cigarettes in his or her lifetime
- Currently smoke cigarettes
- Be able to read and speak English
Who cannot join
- Pregnant women
- Smokers who smoke exclusively roll-your-own cigarettes
- Smokers concurrently enrolled in another cessation study
- Smokers who smoke fewer than 7 cigarettes per week, on average
- Smokers who live in the same household as someone who has enrolled in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pacific Institute for Research and Evaluation
Chapel Hill, North Carolina, 27514
Prevention Research Center of the Pacific Institute for Research & Evaluation
Oakland, California, 94612
About this study
Official title: A Randomized Controlled Trial Evaluating the Impact of Graphic Cigarette Warnings on Smoking Behavior
The purpose of this randomized controlled trial is to determine whether graphic health warnings on cigarette packs are more effective than the existing Surgeon General's warning on cigarette packs at encouraging quit attempts. While previous experiments evaluating candidate graphic warnings have been informative, they have used psychological outcomes, such as attitudes or quit intentions, but not actual cessation behavior (e.g., quit attempts). Furthermore, they typically expose participants to warnings in controlled but artificial experimental settings for a short period of time, using much lower frequency and shorter duration of warning exposure than found in the real world. This study addresses these issues by evaluating the impact of warnings on quit attempts by randomly assigning smokers to have their cigarette packs labeled with either a graphic warning or a Surgeon General's warning for four weeks.
Main hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will be more likely to report a quit attempt in the 4 weeks of the study than smokers randomized to receive a Surgeon General's label on their cigarette packs.
Secondary hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will have higher quit intentions at 4 weeks than smokers randomized to receive a Surgeon General's label on their cigarette packs, controlling for baseline quit intentions.
Read the detailed description
The U.S. Food and Drug Administration (FDA) proposed 9 new graphic warnings for cigarette packs in June 2011 to comply with the Family Smoking Prevention and Tobacco Control Act. However, tobacco industry litigation has delayed implementation of graphic warnings. A court ruling that struck down the labels criticized FDA for failing to "present any data - much less the substantial evidence required under the federal law - showing that enacting their proposed graphic warnings will accomplish the agency's stated objective of reducing smoking rates." This study will address this critique head-on by rigorously testing the impact of the graphic warnings on quit attempts in a randomized control trial.
Recruitment: Smokers will first undergo screening online or call the study center to complete the screening questionnaire over the phone. Study staff will schedule eligible smokers for 5 in-person visits. For each of their first 4 visits, smokers will be asked to bring the number of cigarettes they expect to smoke in an 8 day period.
Informed Consent: Prior to consenting smokers, research staff will visually inspect photo identification of smokers who report or appear to be under age 27. At the beginning of the first appointment, study personnel will explain the consent form and ask the smoker to read the form. Once the participant has finished reading the form, the study personnel member will ask the participant if he or she has any questions. Then both parties will sign the consent form and the participant will receive a copy of the consent form.
Randomization: After smokers have consented to participating in the study, study personnel will randomly assign them to a condition. The investigators will determine the randomization order a priori. Smokers have an equal chance of being randomized to receive one of four graphic warnings or one of four Surgeon General's warnings. They will receive the same warning on their packs during the study.
Assessment: Participants will complete 6 computer-based surveys during the study. The first appointment will take around 60 minutes and each subsequent visit will take around 30-45 minutes to complete. At their first visit, they will complete a "baseline pre-test," after which study personnel will show participants one of their cigarette packs with the assigned warning. Participants will be allowed to examine the pack. They will then return the pack to the study personnel and complete a "baseline post-test." At the next 3 appointments, participants will complete only one survey and their packs will be labeled. At the final appointment, they will only complete a survey.
Detailed description of the intervention: While participants are taking the survey, research staff will apply study warning labels to participants' cigarette packs during the first 4 visits. Participants assigned to the graphic warning condition will receive one of four graphic warning labels that will be applied and cover the top half of the front and back of their cigarette packs. The text for the graphic warnings was selected from the 2009 Family Smoking Prevention and Tobacco Control Act and the images were proposed by the FDA. Participants in the Surgeon General's warning condition will receive one of four Surgeon General's Warnings that will be placed on the side of their packs on top of the Surgeon General's warning printed by the manufacturer. This procedure for the control condition is intended to control for the effects of labeling. The investigators will instruct participants in both conditions to use cigarettes from these labeled packs while they are in the study. Each week they will bring in 8 days' of cigarettes (one extra day to provide a buffer in case of rescheduled appointments or smoking more than anticipated) for labeling. Additionally, they will bring in any unused labeled packs from the previous appointment. The investigators will assess how many cigarettes participants smoke from labeled (i.e., study) and unlabeled (i.e., non-study) packs to calculate intervention dose (% of cigarettes smoked from labeled packs). At the end of the study, participants will receive a list of cessation resources. During the final appointment, participants will also report whether they knew anyone else in the study or saw another participant's labels, to assess potential contamination.
- Conditions
- Smoking
- Being tested
- Surgeon General's Warning, Graphic Warning
- Keywords
- Cigarette smoking, Smoke, Smoking, Tobacco Use
- Medical subject headings
- Smoking, Cigarette Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgeon General's WarningOther
Participants will be randomly assigned to receive warnings with one of the four Surgeon General's Warnings on their cigarette packs for 4 weeks:
- SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.
- SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.
- SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight.
- SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide.
Graphic WarningOther
Participants will be randomly assigned to receive one of the following four graphic warnings on their cigarette packs for 4 weeks:
- Text: "WARNING: Cigarettes are addictive." Image: Man smoking through tracheotomy hole.
- Text: "WARNING: Cigarettes causes fatal lung disease." Image: Healthy lungs next to diseased lungs.
- Text: "WARNING: Cigarettes cause cancer." Image: Mouth with cancerous lesion on lip.
- Text: "WARNING: Smoking can kill you." Image: Woman dying from cancer.
| Study group | Role | What they receive |
|---|---|---|
| Graphic Warning | Experimental | Graphic warnings that include text and an image depicting a health effect of smoking will be applied on labels that cover the top half of the front and back of participants' cigarette packs each week for 4 weeks. Within the graphic warning condition, participants will be assigned to receive 1 of 4 warnings for 4 weeks. The text for these warnings was selected from the 2009 Family Smoking Prevention and Tobacco Control Act and the images were proposed by the FDA. Receives: Other: Graphic Warning |
| Surgeon General's Warning | Active comparator | Labels with Surgeon General's Warning text will be applied to the side of participants' cigarette packs each week for 4 weeks, on top of the Surgeon General's Warning printed by the manufacturer. Receives: Other: Surgeon General's Warning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit attempts
The primary outcome is a quit attempt during the 4 weeks of the study, reported at either 1, 2, 3, or 4 weeks. A quit attempt is defined as 24 hours without smoking.
Measured: Up to 4 weeks
Secondary outcomes (9)
Change in quit intentions
Quit intentions will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using the 3-item quit intention scale developed by Klein, Zajac, and Monin (2009).
Measured: 4 weeks
Successful Quitting
Successful quitting will be defined as self-reported smoking on 0 of the past 7 days at 4 weeks.
Measured: 4 weeks
Change in forgoing a cigarette
Forgoing a cigarette will be measured at baseline pretest, 1, 2, 3, and 4 weeks as the frequency of butting out a cigarette or forgoing a cigarette in an effort to smoke less, using measures developed by the investigators.
Measured: 4 weeks
Change in positive reinforcement attitudes
Positive reinforcement attitudes smoking attitudes will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using measures adapted from the Smoking Consequences Scale developed by Brandon \& Baker (1991).
Measured: 4 weeks
Change in negative reinforcement attitudes
Negative reinforcement attitudes will be measured at baseline pretest and posttest, 1, 2, 3, and 4 weeks using measures adapted from the Smoking Consequences Scale developed by Brandon \& Baker (1991).
Measured: 4 weeks
Change in perceived likelihood
Perceived likelihood of developing smoking-related health outcomes will be measured at baseline pretest, 2, and 4 weeks using measures developed by the investigators.
Measured: 4 weeks
Change in frequency of conversations about warning labels
Frequency of conversations with other about the warning labels, health effects of smoking and quitting in the past week will be measured at baseline pretest, 1, 2, 3, and 4 weeks.
Measured: 4 weeks
Fear
Fear will be measured at baseline posttest, 1, 2, 3, and 4 weeks using items developed by the investigators and adapted from Nonnemaker et al. (2010), Leshner et al. (2011), Watson et al. (1988), and Keller and Block (1996).
Measured: 4 weeks
Cognitive elaboration
Cognitive elaboration will be measured at 1, 2, 3, and 4 weeks adapted from the Depth of Cognitive Processing Scale (Hammond, Fong, McDonald, Cameron, and Brown, 2003) and measures adapted from Fathelrahman et al (2010).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Masking
- None (open label)
- Enrolment
- 2,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Noel Brewer, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247908
- Sponsor's protocol ID
- 13-2861
- Other IDs
- 3P30CA016086-38S2
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2014
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No patient level data will be shared with the general public or other researchers.
Publications
Brewer NT, Parada H, Hall MG, Boynton MH, Noar SM, Ribisl KM. Understanding Why Pictorial Cigarette Pack Warnings Increase Quit Attempts. Ann Behav Med. 2019 Mar 1;53(3):232-243. doi: 10.1093/abm/kay032.
PubMed 29850764Parada H Jr, Hall MG, Boynton MH, Brewer NT. Trajectories of Responses to Pictorial Cigarette Pack Warnings. Nicotine Tob Res. 2018 Jun 7;20(7):876-881. doi: 10.1093/ntr/ntx182.
PubMed 29059340Brewer NT, Hall MG, Noar SM, Parada H, Stein-Seroussi A, Bach LE, Hanley S, Ribisl KM. Effect of Pictorial Cigarette Pack Warnings on Changes in Smoking Behavior: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):905-12. doi: 10.1001/jamainternmed.2016.2621.
PubMed 27273839Brewer NT, Hall MG, Lee JG, Peebles K, Noar SM, Ribisl KM. Testing warning messages on smokers' cigarette packages: a standardised protocol. Tob Control. 2016 Mar;25(2):153-9. doi: 10.1136/tobaccocontrol-2014-051661. Epub 2015 Jan 6.
PubMed 25564282
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Impact of Graphic Cigarette Warnings on Smoking Behavior
- ClinicalTrials.gov ID
- NCT02247908
- Acronym / sponsor ID
- 13-2861
- Conditions
- Smoking
- Keywords
- Cigarette smoking, Smoke, Smoking, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,149 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Sep 2014 (estimated)
- 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 randomized controlled trial is to determine whether graphic health warnings on cigarette packs are more effective than the existing Surgeon General's warning on cigarette packs at encouraging quit attempts. While previous experiments evaluating candidate graphic warnings have been informative, they have used psychological outcomes, such as attitudes or quit intentions, but not actual cessation behavior (e.g., quit attempts). Furthermore, they typically expose participants to warnings in controlled but artificial experimental settings for a short period of time, using much lower frequency and shorter duration of warning exposure than found in the real world. This study addresses these issues by evaluating the impact of warnings on quit attempts by randomly assigning smokers to have their cigarette packs labeled with either a graphic warning or a Surgeon General's warning for four weeks.
Main hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will be more likely to report a quit attempt in the 4 weeks of the study than smokers randomized to receive a Surgeon General's label on their cigarette packs.
Secondary hypothesis: Smokers randomized to receive graphic warnings on their cigarette packs will have higher quit intentions at 4 weeks than smokers randomized to receive a Surgeon General's label on their cigarette packs, controlling for baseline quit intentions.
Detailed description
The U.S. Food and Drug Administration (FDA) proposed 9 new graphic warnings for cigarette packs in June 2011 to comply with the Family Smoking Prevention and Tobacco Control Act. However, tobacco industry litigation has delayed implementation of graphic warnings. A court ruling that struck down the labels criticized FDA for failing to "present any data - much less the substantial evidence required under the federal law - showing that enacting their proposed graphic warnings will accomplish the agency's stated objective of reducing smoking rates." This study will address this critique head-on by rigorously testing the impact of the graphic warnings on quit attempts in a randomized control trial.
Recruitment: Smokers will first undergo screening online or call the study center to complete the screening questionnaire over the phone. Study staff will schedule eligible smokers for 5 in-person visits. For each of their first 4 visits, smokers will be asked to bring the number of cigarettes they expect to smoke in an 8 day period.
Informed Consent: Prior to consenting smokers, research staff will visually inspect photo identification of smokers who report or appear to be under age 27. At the beginning of the first appointment, study personnel will explain the consent form and ask the smoker to read the form. Once the participant has finished reading the form, the study personnel member will ask the participant if he or she has any questions. Then both parties will sign the consent form and the participant will receive a copy of the consent form.
Randomization: After smokers have consented to participating in the study, study personnel will randomly assign them to a condition. The investigators will determine the randomization order a priori. Smokers have an equal chance of being randomized to receive one of four graphic warnings or one of four Surgeon General's warnings. They will receive the same warning on their packs during the study.
Assessment: Participants will complete 6 computer-based surveys during the study. The first appointment will take around 60 minutes and each subsequent visit will take around 30-45 minutes to complete. At their first visit, they will complete a "baseline pre-test," after which study personnel will show participants one of their cigarette packs with the assigned warning. Participants will be allowed to examine the pack. They will then return the pack to the study personnel and complete a "baseline post-test." At the next 3 appointments, participants will complete only one survey and their packs will be labeled. At the final appointment, they will only complete a survey.
Detailed description of the intervention: While participants are taking the survey, research staff will apply study warning labels to participants' cigarette packs during the first 4 visits. Participants assigned to the graphic warning condition will receive one of four graphic warning labels that will be applied and cover the top half of the front and back of their cigarette packs. The text for the graphic warnings was selected from the 2009 Family Smoking Prevention and Tobacco Control Act and the images were proposed by the FDA. Participants in the Surgeon General's warning condition will receive one of four Surgeon General's Warnings that will be placed on the side of their packs on top of the Surgeon General's warning printed by the manufacturer. This procedure for the control condition is intended to control for the effects of labeling. The investigators will instruct participants in both conditions to use cigarettes from these labeled packs while they are in the study. Each week they will bring in 8 days' of cigarettes (one extra day to provide a buffer in case of rescheduled appointments or smoking more than anticipated) for labeling. Additionally, they will bring in any unused labeled packs from the previous appointment. The investigators will assess how many cigarettes participants smoke from labeled (i.e., study) and unlabeled (i.e., non-study) packs to calculate intervention dose (% of cigarettes smoked from labeled packs). At the end of the study, participants will receive a list of cessation resources. During the final appointment, participants will also report whether they knew anyone else in the study or saw another participant's labels, to assess potential contamination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graphic Warning | Experimental | Other: Graphic WarningGraphic warnings that include text and an image depicting a health effect of smoking will be applied on labels that cover the top half of the front and back of participants' cigarette packs each week for 4 weeks. Within the graphic warning condition, participants will be assigned to receive 1 of 4 warnings for 4 weeks. The text for these warnings was selected from the 2009 Family Smoking Prevention and Tobacco Control Act and the images were proposed by the FDA. |
| Surgeon General's Warning | Active comparator | Other: Surgeon General's WarningLabels with Surgeon General's Warning text will be applied to the side of participants' cigarette packs each week for 4 weeks, on top of the Surgeon General's Warning printed by the manufacturer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 18 years or older
- Have smoked at least 100 cigarettes in his or her lifetime
- Currently smoke cigarettes
- Be able to read and speak English
Key exclusion criteria (5 listed)
- Pregnant women
- Smokers who smoke exclusively roll-your-own cigarettes
- Smokers concurrently enrolled in another cessation study
- Smokers who smoke fewer than 7 cigarettes per week, on average
- Smokers who live in the same household as someone who has enrolled in the study
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 |
|---|---|---|
| Surgeon General's WarningParticipants will be randomly assigned to receive warnings with one of the four Surgeon General's Warnings on their cigarette packs for 4 weeks: 1. SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy. 2. SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health. 3. SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight. 4. SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide. | Other | Surgeon General's Warning |
| Graphic WarningParticipants will be randomly assigned to receive one of the following four graphic warnings on their cigarette packs for 4 weeks: 1. Text: "WARNING: Cigarettes are addictive." Image: Man smoking through tracheotomy hole. 2. Text: "WARNING: Cigarettes causes fatal lung disease." Image: Healthy lungs next to diseased lungs. 3. Text: "WARNING: Cigarettes cause cancer." Image: Mouth with cancerous lesion on lip. 4. Text: "WARNING: Smoking can kill you." Image: Woman dying from cancer. | Other | Graphic Warning |
Primary outcome
Quit attempts
Time frame: Up to 4 weeks
The primary outcome is a quit attempt during the 4 weeks of the study, reported at either 1, 2, 3, or 4 weeks. A quit attempt is defined as 24 hours without smoking.
9 secondary outcomes
Change in quit intentions
Time frame: 4 weeks
Successful Quitting
Time frame: 4 weeks
Change in forgoing a cigarette
Time frame: 4 weeks
Change in positive reinforcement attitudes
Time frame: 4 weeks
Change in negative reinforcement attitudes
Time frame: 4 weeks
Change in perceived likelihood
Time frame: 4 weeks
Change in frequency of conversations about warning labels
Time frame: 4 weeks
Fear
Time frame: 4 weeks
Cognitive elaboration
Time frame: 4 weeks
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 14 Sep 2016.
- Derived from this study: PubMed 29850764Brewer NT, Parada H, Hall MG, Boynton MH, Noar SM, Ribisl KM. Understanding Why Pictorial Cigarette Pack Warnings Increase Quit Attempts. Ann Behav Med. 2019 Mar 1;53(3):232-243. doi: 10.1093/abm/kay032.
- Derived from this study: PubMed 29059340Parada H Jr, Hall MG, Boynton MH, Brewer NT. Trajectories of Responses to Pictorial Cigarette Pack Warnings. Nicotine Tob Res. 2018 Jun 7;20(7):876-881. doi: 10.1093/ntr/ntx182.
- Derived from this study: PubMed 27273839Brewer NT, Hall MG, Noar SM, Parada H, Stein-Seroussi A, Bach LE, Hanley S, Ribisl KM. Effect of Pictorial Cigarette Pack Warnings on Changes in Smoking Behavior: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):905-12. doi: 10.1001/jamainternmed.2016.2621.
- Derived from this study: PubMed 25564282Brewer NT, Hall MG, Lee JG, Peebles K, Noar SM, Ribisl KM. Testing warning messages on smokers' cigarette packages: a standardised protocol. Tob Control. 2016 Mar;25(2):153-9. doi: 10.1136/tobaccocontrol-2014-051661. Epub 2015 Jan 6.
- Individual participant dataSharing planned: No. No patient level data will be shared with the general public or other researchers.
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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.
Noel Brewer, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgeon General's Warning and Graphic Warning in people with Smoking, run by University of North Carolina, Chapel Hill 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 4 inclusion and 5 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 14 Sep 2016. 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?
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?
Quit attempts (time frame: Up to 4 weeks). 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 NCT02247908, which also lists 4 linked publications.
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 14 Sep 2016.