- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05110716
Effects of Choice Bundling on Valuation of Delayed Gains and Losses in Cigarette Smokers
October 26, 2021 updated by: Warren K. Bickel, Virginia Polytechnic Institute and State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
308
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Fralin Biomedical Research Institute at VTC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- currently smoke at least 10 cigarettes per day
- have smoked at least 100 cigarettes (lifetime), and
- are 21 years of age or older.
Exclusion Criteria:
- Inaccurate identification of usual brand cigarette's as menthol or non-menthol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gains, Ascending Bundle-Size Order
Participants will complete the choice bundling adjusting-amount task for monetary gains in an ascending order of bundle size.
|
In this condition, each choice in the adjusting-amount task produces only a single consequence (e.g., lose $900 in 1 year).
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).
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).
|
Experimental: Gains, Descending Bundle-Size Order
Participants will complete the choice bundling adjusting-amount task for monetary gains in a descending order of bundle size.
|
In this condition, each choice in the adjusting-amount task produces only a single consequence (e.g., lose $900 in 1 year).
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).
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).
|
Experimental: Losses, Ascending Bundle-Size Order
Participants will complete the choice bundling adjusting-amount task for monetary losses in an ascending order of bundle size.
|
In this condition, each choice in the adjusting-amount task produces only a single consequence (e.g., lose $900 in 1 year).
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).
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).
|
Experimental: Losses, Descending Bundle-Size Order
Participants will complete the choice bundling adjusting-amount task for monetary losses in an ascending order of bundle size.
|
In this condition, each choice in the adjusting-amount task produces only a single consequence (e.g., lose $900 in 1 year).
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).
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day (same session)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Warren K Bickel, PhD, Virginia Polytechnic Institute and State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 26, 2021
Primary Completion (Actual)
August 12, 2021
Study Completion (Actual)
August 12, 2021
Study Registration Dates
First Submitted
October 11, 2021
First Submitted That Met QC Criteria
October 26, 2021
First Posted (Actual)
November 8, 2021
Study Record Updates
Last Update Posted (Actual)
November 8, 2021
Last Update Submitted That Met QC Criteria
October 26, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 20-827
- 5P01CA217806 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Data will become available immediately upon publication of the manuscript and will remain available for 5 years.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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