Cigarette SmokingNCT05110716
Effects of Choice Bundling on Valuation of Delayed Gains and Losses in Cigarette Smokers
A study testing Bundle-size 1, Bundle-size 3 and Bundle-size 9 in people with Cigarette Smoking, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
The present study will investigate the effects of choice bundling, in which a single choice produces a series of repeating consequences, on valuation of delayed monetary gains and losses in an online panel of cigarette smokers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Bundle-size 1, Bundle-size 3 and Bundle-size 9
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2021to 12 Aug 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently smoke at least 10 cigarettes per day
- have smoked at least 100 cigarettes (lifetime), and
- are 21 years of age or older.
Who cannot join
- Inaccurate identification of usual brand cigarette's as menthol or non-menthol
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
The present study will investigate the effects of choice bundling, in which a single choice produces a series of repeating consequences, on valuation of delayed monetary gains and losses in an online panel of cigarette smokers.
Read the detailed description
Choice bundling, in which a single choice produces a series of repeating consequences, has been shown to increase valuation of delayed monetary and non-monetary gains. Interventions derived from this manipulation may be an effective method for mitigating the elevated delay discounting rates observed in cigarette smokers. No prior work, however, has investigated whether effects of choice bundling generalize to reward losses. In the present study, an online panel of cigarette smokers, recruited using Ipsos, will complete assessments for either monetary gains or losses (randomly assigned). In Step 1, participants will complete a delay-discounting task to establish Effective Delay 50 (ED50), or the delay required for a monetary outcome to lose half of its value. In Step 2, participants will complete three conditions of an adjusting-amount task, choosing between a smaller, sooner (SS) adjusting amount and a larger, later (LL) fixed amount. The bundle size (i.e., number of consequences) will be manipulated across conditions, where a single choice will produce either 1 (control), 3, or 9 consequences over time (ascending/descending order counterbalanced). The delay to the first LL amount in each condition, as well as the intervals between all additional SS and LL amounts (where applicable), will be set to individual participants' ED50 values from Step 1 to control for differences in discounting of gains and losses.
- Conditions
- Cigarette Smoking
- Being tested
- Bundle-size 1, Bundle-size 3, Bundle-size 9
- Keywords
- Behavior, Smoking, Cigarette, Tobacco, Delay discounting, Intertemporal choice
- Medical subject headings
- Cigarette Smoking, Behavior, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundle-size 1Behavioural
In this condition, each choice in the adjusting-amount task produces only a single consequence (e.g., lose $900 in 1 year).
Bundle-size 3Behavioural
In this condition, each choice in the adjusting-amount task produce a series of three consequences over time. o hold total amount constant across conditions, the $900 available in the bundle-size 1 condition will be distributed equally across all consequences in the series. (e.g., lose $300 in 1 year, lose $300 in 2 years, lose $300 in 3 years).
Bundle-size 9Behavioural
In this condition, each choice in the adjusting-amount task produce a series of nine consequences over time. To hold total amount constant across conditions, the $900 available in the bundle-size 1 condition will be distributed equally across all consequences in the series. (e.g., lose $100 in 1 year, lose $100 in 2 years, lose $100 in 3 years...lose $100 in 9 years).
| Study group | Role | What they receive |
|---|---|---|
| Gains, Ascending Bundle-Size Order | Experimental | Participants will complete the choice bundling adjusting-amount task for monetary gains in an ascending order of bundle size. Receives: Behavioral: Bundle-size 1; Behavioral: Bundle-size 3; Behavioral: Bundle-size 9 |
| Gains, Descending Bundle-Size Order | Experimental | Participants will complete the choice bundling adjusting-amount task for monetary gains in a descending order of bundle size. Receives: Behavioral: Bundle-size 1; Behavioral: Bundle-size 3; Behavioral: Bundle-size 9 |
| Losses, Ascending Bundle-Size Order | Experimental | Participants will complete the choice bundling adjusting-amount task for monetary losses in an ascending order of bundle size. Receives: Behavioral: Bundle-size 1; Behavioral: Bundle-size 3; Behavioral: Bundle-size 9 |
| Losses, Descending Bundle-Size Order | Experimental | Participants will complete the choice bundling adjusting-amount task for monetary losses in an ascending order of bundle size. Receives: Behavioral: Bundle-size 1; Behavioral: Bundle-size 3; Behavioral: Bundle-size 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indifference points
Participants complete three conditions of the adjusting-amount task (one at each bundle size), in which they choose between a larger, delayed amount ($900) and a smaller, immediate amount. Across trials, the smaller amount titrates until reaching an indifference point. This indifference point provides an index of the value of the larger option. For example, an indifference point of $300 indicates the larger, delayed amount as been discounted by two thirds. Higher values reflect less delay discounting.
Measured: 1 day (same session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start26 Jul 2021
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either a gains or losses group and subsequently complete conditions at bundle-sizes 1, 3, and 9 (within-subjects, order counterbalanced).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Minnesota
- Responsible party
- Principal investigator, Jeffrey Stein, Virginia Polytechnic Institute and State University
- Investigators
- Warren K Bickel, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110716
- Sponsor's protocol ID
- 20-827
- Other IDs
- 5P01CA217806
- Status last verified
- Jan 2025
- First submitted
- 11 Oct 2021
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be made available from the Open Science Framework (OSF) database. The url providing access to data will be provided in study publications.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Choice Bundling on Valuation of Delayed Gains and Losses in Cigarette Smokers
- ClinicalTrials.gov ID
- NCT05110716
- Acronym / sponsor ID
- 20-827
- Conditions
- Cigarette Smoking
- Keywords
- Behavior, Smoking, Cigarette, Tobacco, Delay discounting, Intertemporal choice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Minnesota
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 8 Nov 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 present study will investigate the effects of choice bundling, in which a single choice produces a series of repeating consequences, on valuation of delayed monetary gains and losses in an online panel of cigarette smokers.
Detailed description
Choice bundling, in which a single choice produces a series of repeating consequences, has been shown to increase valuation of delayed monetary and non-monetary gains. Interventions derived from this manipulation may be an effective method for mitigating the elevated delay discounting rates observed in cigarette smokers. No prior work, however, has investigated whether effects of choice bundling generalize to reward losses. In the present study, an online panel of cigarette smokers, recruited using Ipsos, will complete assessments for either monetary gains or losses (randomly assigned). In Step 1, participants will complete a delay-discounting task to establish Effective Delay 50 (ED50), or the delay required for a monetary outcome to lose half of its value. In Step 2, participants will complete three conditions of an adjusting-amount task, choosing between a smaller, sooner (SS) adjusting amount and a larger, later (LL) fixed amount. The bundle size (i.e., number of consequences) will be manipulated across conditions, where a single choice will produce either 1 (control), 3, or 9 consequences over time (ascending/descending order counterbalanced). The delay to the first LL amount in each condition, as well as the intervals between all additional SS and LL amounts (where applicable), will be set to individual participants' ED50 values from Step 1 to control for differences in discounting of gains and losses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants are randomly assigned to either a gains or losses group and subsequently complete conditions at bundle-sizes 1, 3, and 9 (within-subjects, order counterbalanced).
| Arm | Type | Receives |
|---|---|---|
| Gains, Ascending Bundle-Size Order | Experimental | Behavioral: Bundle-size 1, Behavioral: Bundle-size 3, Behavioral: Bundle-size 9Participants will complete the choice bundling adjusting-amount task for monetary gains in an ascending order of bundle size. |
| Gains, Descending Bundle-Size Order | Experimental | Behavioral: Bundle-size 1, Behavioral: Bundle-size 3, Behavioral: Bundle-size 9Participants will complete the choice bundling adjusting-amount task for monetary gains in a descending order of bundle size. |
| Losses, Ascending Bundle-Size Order | Experimental | Behavioral: Bundle-size 1, Behavioral: Bundle-size 3, Behavioral: Bundle-size 9Participants will complete the choice bundling adjusting-amount task for monetary losses in an ascending order of bundle size. |
| Losses, Descending Bundle-Size Order | Experimental | Behavioral: Bundle-size 1, Behavioral: Bundle-size 3, Behavioral: Bundle-size 9Participants will complete the choice bundling adjusting-amount task for monetary losses in an ascending order of bundle size. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- currently smoke at least 10 cigarettes per day
- have smoked at least 100 cigarettes (lifetime), and
- are 21 years of age or older.
Key exclusion criteria (1 listed)
- Inaccurate identification of usual brand cigarette's as menthol or non-menthol
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 |
|---|---|---|
| Bundle-size 1In this condition, each choice in the adjusting-amount task produces only a single consequence (e.g., lose $900 in 1 year). | Behavioural | Gains, Ascending Bundle-Size Order, Gains, Descending Bundle-Size Order, Losses, Ascending Bundle-Size Order, Losses, Descending Bundle-Size Order |
| Bundle-size 3In this condition, each choice in the adjusting-amount task produce a series of three consequences over time. o hold total amount constant across conditions, the $900 available in the bundle-size 1 condition will be distributed equally across all consequences in the series. (e.g., lose $300 in 1 year, lose $300 in 2 years, lose $300 in 3 years). | Behavioural | Gains, Ascending Bundle-Size Order, Gains, Descending Bundle-Size Order, Losses, Ascending Bundle-Size Order, Losses, Descending Bundle-Size Order |
| Bundle-size 9In this condition, each choice in the adjusting-amount task produce a series of nine consequences over time. To hold total amount constant across conditions, the $900 available in the bundle-size 1 condition will be distributed equally across all consequences in the series. (e.g., lose $100 in 1 year, lose $100 in 2 years, lose $100 in 3 years...lose $100 in 9 years). | Behavioural | Gains, Ascending Bundle-Size Order, Gains, Descending Bundle-Size Order, Losses, Ascending Bundle-Size Order, Losses, Descending Bundle-Size Order |
Primary outcome
Indifference points
Time frame: 1 day (same session)
Participants complete three conditions of the adjusting-amount task (one at each bundle size), in which they choose between a larger, delayed amount ($900) and a smaller, immediate amount. Across trials, the smaller amount titrates until reaching an indifference point. This indifference point provides an index of the value of the larger option. For example, an indifference point of $300 indicates the larger, delayed amount as been discounted by two thirds. Higher values reflect less delay discounting.
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 24 Jan 2025.
- Individual participant dataSharing planned: Yes. De-identified participant data will be made available from the Open Science Framework (OSF) database. The url providing access to data will be provided in study publications.
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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.
Warren K Bickel, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bundle-size 1, Bundle-size 3 and Bundle-size 9 in people with Cigarette Smoking, run by Virginia Polytechnic Institute and State University 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 3 inclusion and 1 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indifference points (time frame: 1 day (same session)). 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 24 Jan 2025.