Smoking CessationNCT01923467
Project Quit: Positive vs. Negative Offers of an Online Stop Smoking Program
A study testing Project Quit stop smoking program and Nicotine patches 21 mg in people with Smoking Cessation, run by University of Michigan at 1 site in United States.
Trial summary
This project is designed to test the effects of affirmation and positive/negative imagery on individuals' thoughts about quitting smoking and willingness to join a stop smoking program. 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?
- Project Quit stop smoking program and Nicotine patches 21 mg
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 767 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 2014
- 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
- Current smoker
Who cannot join
- Current participation in another stop-smoking program
- Current use of stop smoking medications
- Pregnant or breastfeeding
- Limited internet or email access
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Health Communications Research, University of Michigan
Ann Arbor, Michigan, 48109
About this study
This project is designed to test the effects of affirmation and positive/negative imagery on individuals' thoughts about quitting smoking and willingness to join a stop smoking program. Previous studies have noted that viewing negative images elicits a stronger emotional response, and many stop-smoking campaigns have used such images to push people to quit smoking. However, research also shows that people are generally resistant to health messages. Using affirmation can help to lessen that resistance.
In this study, we use a 2x3 design to study the individual effects of negative imagery and affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit smoking program, and program participation and outcomes. We hope to find out whether there is an additive effect of the negative imagery and affirmation on the outcomes listed above. Our specific aims are:
Read more
Aim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking program.
Aim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of the stop smoking program offer.
Aim 3: Determine whether there is an interaction between image type and affirmation in people's willingness to join a stop smoking program.
- Conditions
- Smoking Cessation
- Being tested
- Project Quit stop smoking program, Nicotine patches 21 mg
- Keywords
- smoking, nicotine replacement, internet
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project Quit stop smoking programBehavioural
This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.
Nicotine patches 21 mgDrug
Also called Nicoderm CQ Step 1 (21 mg)
Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt.
| Study group | Role | What they receive |
|---|---|---|
| Project Quit plus NRT patches | Experimental | All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg. Receives: Behavioral: Project Quit stop smoking program; Drug: Nicotine patches 21 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of Offer to Join Stop Smoking Program
After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program.
Measured: 1 Day of Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionApr 2014
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 CessationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 767 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Lawrence C. An, University of Michigan
- Investigators
- Lawrence C An, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923467
- Sponsor's protocol ID
- P50CA101451
- Status last verified
- Dec 2014
- First submitted
- 13 Aug 2013
- Last updated
- 15 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Quit: Positive vs. Negative Offers of an Online Stop Smoking Program
- ClinicalTrials.gov ID
- NCT01923467
- Acronym / sponsor ID
- P50CA101451
- Conditions
- Smoking Cessation
- Keywords
- smoking, nicotine replacement, internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 767 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Posted 15 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is designed to test the effects of affirmation and positive/negative imagery on individuals' thoughts about quitting smoking and willingness to join a stop smoking program. Previous studies have noted that viewing negative images elicits a stronger emotional response, and many stop-smoking campaigns have used such images to push people to quit smoking. However, research also shows that people are generally resistant to health messages. Using affirmation can help to lessen that resistance.
In this study, we use a 2x3 design to study the individual effects of negative imagery and affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit smoking program, and program participation and outcomes. We hope to find out whether there is an additive effect of the negative imagery and affirmation on the outcomes listed above. Our specific aims are:
Aim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking program.
Aim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of the stop smoking program offer.
Aim 3: Determine whether there is an interaction between image type and affirmation in people's willingness to join a stop smoking program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Project Quit plus NRT patches | Experimental | Behavioral: Project Quit stop smoking program, Drug: Nicotine patches 21 mgAll participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current smoker
Key exclusion criteria (4 listed)
- Current participation in another stop-smoking program
- Current use of stop smoking medications
- Pregnant or breastfeeding
- Limited internet or email access
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 |
|---|---|---|
| Project Quit stop smoking programThis online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success. | Behavioural | Project Quit plus NRT patches |
| Nicotine patches 21 mgAlso: Nicoderm CQ Step 1 (21 mg)Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt. | Drug | Project Quit plus NRT patches |
Primary outcome
Acceptance of Offer to Join Stop Smoking Program
Time frame: 1 Day of Enrollment
After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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.
Lawrence C An, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Quit stop smoking program and Nicotine patches 21 mg in people with Smoking Cessation, run by University of Michigan 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 1 inclusion and 4 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 15 Jun 2015. 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 15 Jun 2015). 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?
Acceptance of Offer to Join Stop Smoking Program (time frame: 1 Day of Enrollment). 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 15 Jun 2015.