Adherence, MedicationNCT04754867
Pre-Test of For the Future Self and Smoking Cessation
A study testing Future Self Virtual Reality Image - Normal Aging, Future Self Virtual Reality Image - Smoking Consequences Aging and Current Self Virtual Reality Image in people with Adherence, Medication, run by Carnegie Mellon University.
Trial summary
The goal of this experimental research is to increase adherence to a smoking cessation patch among Pittsburgh residents who are trying to quit smoking. The literature on smoking cessation shows that there is a significant problem with adherence when using a transdermal patch as a nicotine replacement treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Adherence, Medication
- What is being tested?
- Future Self Virtual Reality Image - Normal Aging, Future Self Virtual Reality Image - Smoking Consequences Aging and Current Self Virtual Reality Image
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Dec 2017
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Considering enrollment or recently enrolled (within 1 week) in one of the three designated smoking cessation programs
Who cannot join
- Use of any form of tobacco other than cigarettes
- Use of nicotine gum
- History of alcohol or drug dependency
About this study
Official title: Pre-Test of For the Future Self: A Behavioral Intervention to Increase Success in a Smoking Cessation Program
The goal of this experimental research is to increase adherence to a smoking cessation patch among Pittsburgh residents who are trying to quit smoking. The literature on smoking cessation shows that there is a significant problem with adherence when using a transdermal patch as a nicotine replacement treatment. Less than half of patients use the patch as prescribed and adherence suffers a rapid decline during the first six weeks of treatment (Waldroup, Gifford, \& Kalra, 2006). Recent work in psychology demonstrates that being more connected to our "future selves" enables better long-term decision making, in part by making future rewards more salient (and making present rewards less so). To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program, investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images.
Read the detailed description
Several factors are thought to be relevant to the level of adherence such as the initial level of nicotine addiction (Orleans et al., 1994), gender (Gritz, Nielsen, \& Brooks, 1996), concerns over weight gain due to smoking cessation (Fagerström, 2002) and side effects (Burns \& Levinson, 2008). On the other hand, combining nicotine replacement treatment with behavioral therapy has been shown to improve adherence and overall abstinence (Cooper et al., 2004) and motivation is found to be an important factor related to patch use (Alterman, Gariti, Cook, \& Cnaan, 1999).
Can a more vivid connection to an individual's future self facilitate smoking cessation? While behavioral interventions that enhance connection to the future self have been proven effective at mitigating present bias, they have so far been done in domains that require self-restraint (e.g., delinquency). Smoking cessation does in part require restraint, but a cessation program utilizing the nicotine patch also requires proactive daily commitment and action. Little research has been done to establish the effectiveness of a future selves intervention on behaviors that require proactive action.
Recent work in psychology demonstrates that being more connected to our "future selves" enables better long-term decision making, in part by making future rewards more salient (and making present rewards less so). To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program, investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images. Participants in the "discontinued smoker" age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future, a frontal and profile view; participants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.); participants in the current self virtual reality condition will see their present age self in a virtual reality rendering. Participants in all conditions will write a 200-300 word letter to themselves (in the treatment condition, the letter is written to their self in 20 years; in control, the letter is written to themselves in 3 months). The investigators will measure the impact of the behavioral intervention on participants' expected efficacy with smoking cessation, self-reported patch adherence, and smoking cessation success 2 and 8 weeks later.
The investigators will collect self-reported and non-invasive physiological adherence data over the course of 8 weeks on participants' adherence to the nicotine patch (self-report) and success with smoking cessation (self-report and CO analysis). For those participants self-reporting zero cigarettes smoked in the 7 day period before lab visits, investigators will administer a breath CO assessment (a simple procedure where the participant breathes into a tube and the device analyzes how many carbon dioxide parts per million are in the breath). The investigators will also asks participants if they would be willing to receive an email invitation to an online, 3-question, 6-month follow-up survey to occur four months after their last in-person visit to the laboratory.
The data collected will not be tied to identifiers; it will be used in statistical analyses assessing the effects of the intervention.
- Conditions
- Adherence, Medication
- Being tested
- Future Self Virtual Reality Image - Normal Aging, Future Self Virtual Reality Image - Smoking Consequences Aging, Current Self Virtual Reality Image, Letter - 20 years, Letter - 3 months
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Future Self Virtual Reality Image - Normal AgingBehavioural
Using software developed for this purpose, a current photograph of the subject will be aged and presented through a visual medium. The image (face) will be rendered as a 3D virtual reality avatar.
Future Self Virtual Reality Image - Smoking Consequences AgingBehavioural
Using software developed for this purpose, a current photograph of the participant will be aged showing the results of continued smoking and presented through a visual medium. The image (face) will be rendered as a 3D virtual reality avatar.
Current Self Virtual Reality ImageBehavioural
Using software developed for this purpose, a current photograph of the participant will be rendered as a 3D virtual reality avatar.
Letter - 20 yearsBehavioural
Participants will write a 200-300 word letter to the self they see in that image in 20 years' time. The instructions will read: "Think about who you will be in 20 years from now, and write about the person you are now. What things are important and dear to you, and how do you see your life?"
Letter - 3 monthsBehavioural
Participants will write a 200-300 word letter to the self they see in that image. The instructions will read: "Think about who you will be in 3 months from now, and write about the person you are now. What things are important and dear to you, and how do you see your life?"
| Study group | Role | What they receive |
|---|---|---|
| "discontinued-smoker" age-progressed | Experimental | Participants in the "discontinued smoker" age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future, a frontal and profile view. Receives: Behavioral: Future Self Virtual Reality Image - Normal Aging; Behavioral: Letter - 20 years |
| "discontinued-smoker" + "continued smoking" age-progressed | Experimental | Participants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.). Receives: Behavioral: Future Self Virtual Reality Image - Normal Aging; Behavioral: Future Self Virtual Reality Image - Smoking Consequences Aging; Behavioral: Letter - 20 years |
| Current self virtual reality images | Experimental | Participants in the current self virtual reality condition will see their present age self in a virtual reality rendering. Receives: Behavioral: Current Self Virtual Reality Image; Behavioral: Letter - 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence at two weeks
In the past 2 weeks, how often did you wear a nicotine patch?
Measured: Two weeks after initial intervention
Adherence at eight weeks
In the past 2 weeks, how often did you wear a nicotine patch?
Measured: Eight weeks after initial intervention
Secondary outcomes (4)
Abstinence at two weeks
In the past 2 weeks, how often did you smoke a cigarette?
Measured: Two weeks after initial intervention
Abstinence at eight weeks
In the past 2 weeks, how often did you smoke a cigarette?
Measured: Eight weeks after initial intervention
CO ppm at two weeks
Subjects will blow into CO analyzer.
Measured: Two weeks after initial intervention
CO ppm at eight weeks
Subjects will blow into CO analyzer.
Measured: Eight weeks after initial intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study startOct 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Never initiated. PI has left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, MedicationStudies 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
- Parallel groups
- Model description
- Investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754867
- Sponsor's protocol ID
- STUDY2016_00000551
- Status last verified
- Feb 2021
- First submitted
- 20 Sep 2017
- Last updated
- 15 Feb 2021
- Results posted
- 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 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Test of For the Future Self: A Behavioral Intervention to Increase Success in a Smoking Cessation Program
- ClinicalTrials.gov ID
- NCT04754867
- Acronym / sponsor ID
- STUDY2016_00000551
- Conditions
- Adherence, Medication
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never initiated. PI has left the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Study start
- Oct 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Feb 2021 (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 goal of this experimental research is to increase adherence to a smoking cessation patch among Pittsburgh residents who are trying to quit smoking. The literature on smoking cessation shows that there is a significant problem with adherence when using a transdermal patch as a nicotine replacement treatment. Less than half of patients use the patch as prescribed and adherence suffers a rapid decline during the first six weeks of treatment (Waldroup, Gifford, \& Kalra, 2006). Recent work in psychology demonstrates that being more connected to our "future selves" enables better long-term decision making, in part by making future rewards more salient (and making present rewards less so). To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program, investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images.
Detailed description
Several factors are thought to be relevant to the level of adherence such as the initial level of nicotine addiction (Orleans et al., 1994), gender (Gritz, Nielsen, \& Brooks, 1996), concerns over weight gain due to smoking cessation (Fagerström, 2002) and side effects (Burns \& Levinson, 2008). On the other hand, combining nicotine replacement treatment with behavioral therapy has been shown to improve adherence and overall abstinence (Cooper et al., 2004) and motivation is found to be an important factor related to patch use (Alterman, Gariti, Cook, \& Cnaan, 1999).
Can a more vivid connection to an individual's future self facilitate smoking cessation? While behavioral interventions that enhance connection to the future self have been proven effective at mitigating present bias, they have so far been done in domains that require self-restraint (e.g., delinquency). Smoking cessation does in part require restraint, but a cessation program utilizing the nicotine patch also requires proactive daily commitment and action. Little research has been done to establish the effectiveness of a future selves intervention on behaviors that require proactive action.
Recent work in psychology demonstrates that being more connected to our "future selves" enables better long-term decision making, in part by making future rewards more salient (and making present rewards less so). To test whether a future selves intervention might facilitate patch adherence in a smoking cessation program, investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images. Participants in the "discontinued smoker" age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future, a frontal and profile view; participants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.); participants in the current self virtual reality condition will see their present age self in a virtual reality rendering. Participants in all conditions will write a 200-300 word letter to themselves (in the treatment condition, the letter is written to their self in 20 years; in control, the letter is written to themselves in 3 months). The investigators will measure the impact of the behavioral intervention on participants' expected efficacy with smoking cessation, self-reported patch adherence, and smoking cessation success 2 and 8 weeks later.
The investigators will collect self-reported and non-invasive physiological adherence data over the course of 8 weeks on participants' adherence to the nicotine patch (self-report) and success with smoking cessation (self-report and CO analysis). For those participants self-reporting zero cigarettes smoked in the 7 day period before lab visits, investigators will administer a breath CO assessment (a simple procedure where the participant breathes into a tube and the device analyzes how many carbon dioxide parts per million are in the breath). The investigators will also asks participants if they would be willing to receive an email invitation to an online, 3-question, 6-month follow-up survey to occur four months after their last in-person visit to the laboratory.
The data collected will not be tied to identifiers; it will be used in statistical analyses assessing the effects of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Investigators will recruit participants planning to begin using nicotine patches in local smoking cessation programs, and randomly assign them to one of three conditions: 1) "discontinued-smoker" age-progressed future self virtual reality images vs. 2) "discontinued-smoker" + "continued smoking" age-progressed future self virtual reality images vs. 3) control - current self virtual reality images.
| Arm | Type | Receives |
|---|---|---|
| "discontinued-smoker" age-progressed | Experimental | Behavioral: Future Self Virtual Reality Image - Normal Aging, Behavioral: Letter - 20 yearsParticipants in the "discontinued smoker" age-progressed virtual reality condition will see two rendering of themselves in optimal health twenty years into the future, a frontal and profile view. |
| "discontinued-smoker" + "continued smoking" age-progressed | Experimental | Behavioral: Future Self Virtual Reality Image - Normal Aging, Behavioral: Future Self Virtual Reality Image - Smoking Consequences Aging, Behavioral: Letter - 20 yearsParticipants in the "discontinued smoker" + "continued smoking" age-progressed virtual reality condition will see two frontal renderings of themselves twenty years in the future, one in optimal health and one incorporating appearance-related medical consequences of moderate-heavy smoking over twenty years (e.g., skin that is dry and discolored, increased wrinkles, etc.). |
| Current self virtual reality images | Experimental | Behavioral: Current Self Virtual Reality Image, Behavioral: Letter - 3 monthsParticipants in the current self virtual reality condition will see their present age self in a virtual reality rendering. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Considering enrollment or recently enrolled (within 1 week) in one of the three designated smoking cessation programs
Key exclusion criteria (3 listed)
- Use of any form of tobacco other than cigarettes
- Use of nicotine gum
- History of alcohol or drug dependency
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 |
|---|---|---|
| Future Self Virtual Reality Image - Normal AgingUsing software developed for this purpose, a current photograph of the subject will be aged and presented through a visual medium. The image (face) will be rendered as a 3D virtual reality avatar. | Behavioural | "discontinued-smoker" + "continued smoking" age-progressed, "discontinued-smoker" age-progressed |
| Future Self Virtual Reality Image - Smoking Consequences AgingUsing software developed for this purpose, a current photograph of the participant will be aged showing the results of continued smoking and presented through a visual medium. The image (face) will be rendered as a 3D virtual reality avatar. | Behavioural | "discontinued-smoker" + "continued smoking" age-progressed |
| Current Self Virtual Reality ImageUsing software developed for this purpose, a current photograph of the participant will be rendered as a 3D virtual reality avatar. | Behavioural | Current self virtual reality images |
| Letter - 20 yearsParticipants will write a 200-300 word letter to the self they see in that image in 20 years' time. The instructions will read: "Think about who you will be in 20 years from now, and write about the person you are now. What things are important and dear to you, and how do you see your life?" | Behavioural | "discontinued-smoker" + "continued smoking" age-progressed, "discontinued-smoker" age-progressed |
| Letter - 3 monthsParticipants will write a 200-300 word letter to the self they see in that image. The instructions will read: "Think about who you will be in 3 months from now, and write about the person you are now. What things are important and dear to you, and how do you see your life?" | Behavioural | Current self virtual reality images |
Primary outcome
Adherence at two weeks
Time frame: Two weeks after initial intervention
In the past 2 weeks, how often did you wear a nicotine patch?
Adherence at eight weeks
Time frame: Eight weeks after initial intervention
In the past 2 weeks, how often did you wear a nicotine patch?
4 secondary outcomes
Abstinence at two weeks
Time frame: Two weeks after initial intervention
Abstinence at eight weeks
Time frame: Eight weeks after initial intervention
CO ppm at two weeks
Time frame: Two weeks after initial intervention
CO ppm at eight weeks
Time frame: Eight weeks after initial intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Future Self Virtual Reality Image - Normal Aging, Future Self Virtual Reality Image - Smoking Consequences Aging and Current Self Virtual Reality Image in people with Adherence, Medication, run by Carnegie Mellon University.
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 3 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: withdrawn, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Adherence at two weeks (time frame: Two weeks after initial intervention). 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 15 Feb 2021.