Effects of Choice Bundling on Valuation of Delayed Gains and Losses in Cigarette Smokers

January 21, 2025 updated by: Jeffrey Stein, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Bundle-size 1
In this condition, each choice in the adjusting-amount task produces only a single consequence (e.g., lose $900 in 1 year).
Behavioral: Bundle-size 3
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).
Behavioral: Bundle-size 9
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.
Behavioral: Bundle-size 1
In this condition, each choice in the adjusting-amount task produces only a single consequence (e.g., lose $900 in 1 year).
Behavioral: Bundle-size 3
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).
Behavioral: Bundle-size 9
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.
Behavioral: Bundle-size 1
In this condition, each choice in the adjusting-amount task produces only a single consequence (e.g., lose $900 in 1 year).
Behavioral: Bundle-size 3
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).
Behavioral: Bundle-size 9
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.
Behavioral: Bundle-size 1
In this condition, each choice in the adjusting-amount task produces only a single consequence (e.g., lose $900 in 1 year).
Behavioral: Bundle-size 3
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).
Behavioral: Bundle-size 9
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Polytechnic Institute and State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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