Tobacco Use Disorder/Cigarette SmokingRTANCT05210608
Working Memory Training on Delay Discounting Among Cigarette Smokers
A study testing Working Memory Training + Behavioral Intervention in people with Tobacco Use Disorder/Cigarette Smoking, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Despite widespread awareness of significant negative health consequences, cigarette smoking remains the leading cause of preventable morbidity and mortality in the US (Creamer et al., 2019; Jamal, 2018). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder/Cigarette Smoking
- What is being tested?
- Working Memory Training + Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 30 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: To be included in this study, a participant must be 18 years of age or older, who have smoked at least four cigarettes per day for at least 6 months, are interested in quitting cigarette smoking, are at or below the federal poverty line based on persons in family/household and annual household income:
- 1 -- $12,880
- 2 -- $17,420
- 3 -- $21,960
- 4 - $26,500
- 5 -- $31,040
- 6 -- $35,580
- 7 -- $40,120
- 8 -- $44,660
- 9 - add $4,540 for each additional person,
OR they or their child(ren) utilize a federal program for low-income individuals, and are willing to participate in a 5-week working memory training program as a pretreatment adjunct to behavioral group + nicotine replacement therapy (NRT; via nicotine patches).
Exclusion criteria: Participants must not indicate a severe substance use disorder according to the DSM-V with any substance other than tobacco or have any significant medical or psychiatric condition. Such conditions could include traumatic brain injury, dementia, significant learning disability, or psychotic symptoms. Participants must be at least at a 5th-grade reading level. In case that participants are excluded, they will be provided with resources in the community and provided with contact information for the Kansas Tobacco Quitline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remember to Abstain: Assessment of Working Memory Training on Delay Discounting in Low-SES Cigarette Smokers
Despite widespread awareness of significant negative health consequences, cigarette smoking remains the leading cause of preventable morbidity and mortality in the US (Creamer et al., 2019; Jamal, 2018). Moreover, the highest rate of smoking and heaviest burden of smoking-related illness occurs among low-socioeconomic status (SES) individuals relative to higher SES groups (Businelle et al., 2010; Clegg et al., 2009). Low SES individuals are also 40% less likely to succeed in quitting smoking when they attempt to do so (National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health, 2014). One potential explanation for the disparity in rate of smoking and successful quit attempts may be differences in individual rates of delay discounting (DD), i.e., the degree to which rewards loses their value as the delays to their receipt increase (Odum, 2011). A proposed way to reduce steep DD and, potentially, substance use has been computer training for working memory, which has shown favorable results in a sample of individuals with stimulant dependence (Bickel et al., 2011) and substance use broadly (Felton et al., 2019), with the latter even showing decreases in cigarette smoking in a subset of the sample.
Read the detailed description
The highest rate of smoking and heaviest burden of smoking-related illness occurs among low-SES individuals (Businelle et al., 2010; Clegg et al., 2009). One explanation for this disparity may be differences in individual rates of DD, which have been showed to be reduced with working memory training. (Bickel et al., 2011; Felton et al., 2019). Given the low cost of administering working memory training, such an intervention may be favorable for low-SES populations to improve smoking cessation outcomes.
DD has significant associations with:
Cigarette smoking (smokers tend to have higher rates of DD compared to non-smokers; Bickel et al., 1999);
Smoking treatment outcome (individuals who remained smoke free after a smoking cessation intervention had lower DD compared to those who didn't; González-Roz et al., 2019; Krishnan-Sarin et al., 2007; MacKillop \& Kahler, 2009; Yoon et al., 2007); SES (individuals with lower education and income have higher DD rates compared to those who are more educated and affluent; de Wit et al., 2007; Reimers et al., 2009).
An innovative way to reduce DD that has been proposed is via working memory (WM) training. WM refers to one's capacity to hold information while engaging in complex mental tasks, including reasoning, comprehension, and learning (Baddeley, 2010). Previous research has shown that DD and WM correlate negatively (Shamosh et al., 2008), that individuals with higher DD rates show neural deficits in WM (Herting et al., 2010), and that acute nicotine abstinence is associated with WM deficits (Mendrek et al., 2006; Patterson et al., 2010). Furthermore, previous studies targeting WM to reduce DD have shown favorable results in a sample of individuals with stimulant dependence (Bickel et al., 2011) and substance use broadly (Felton et al., 2019), with the latter even showing decreases in cigarette smoking in a subset of the sample.
Although previous research has shown WM training to reduce DD (which would support H3), and cigarette use in a small subsample, the hypotheses of this study are largely exploratory. However, given the theoretical connections between DD, SES, and WM, it is expected that the hypotheses of this project will be supported.
The performance of this project may advance our knowledge of the relevant clinical targets for smoking cessation in low-SES individuals. In particular, this project is expected to shed light on DD as the putative mechanism in smoking for low-SES individuals and the durability of reductions in smoking as a result of reductions in DD through WM training.
Despite the evidence for some successful techniques for reducing DD, little of this work has been translated into intervention approaches to target clinical outcomes. This application seeks to capitalize on the emerging literatures indicating (1) WM training may be an effective and efficient way to reduce DD, and (2) DD is associated with SES, cigarette smoking, and treatment outcomes. Though WM training has been successfully implemented in laboratory-controlled experiments to reduce DD, we are not aware of any interventions for clinical disorders that specifically seek to do so and potentially enhance treatment outcomes.
The development of effective, theoretically coherent interventions addressing cigarette smoking is imperative, particularly interventions that would be feasible, efficacious, and acceptable in low-SES individuals. The proposed research is an innovative approach that capitalizes on previous findings showing reductions in delay discounting and even cigarette smoking. If working memory training is found to improve smoking cessation outcomes as a function of reductions in delay discounting, the project results could be helpful in future development of low-cost interventions for cigarette smoking.
- Conditions
- Tobacco Use Disorder/Cigarette Smoking
- Being tested
- Working Memory Training + Behavioral Intervention
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working Memory Training + Behavioral InterventionBehavioural
Participants will be randomized to complete 10 sessions of a Working Memory Training. All participants will receive behavioral activation (a behavioral intervention for smoking cessation) and nicotine patches.
| Study group | Role | What they receive |
|---|---|---|
| Working Memory Training + Behavioral Intervention | Experimental | Participants will complete 10 sessions of a Working Memory Training. All participants will receive behavioral activation (a behavioral intervention for smoking cessation) and nicotine patches. Receives: Behavioral: Working Memory Training + Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay Discounting
Delay Discounting (DD) was measured via an established computerized binary choice task in which participants choose between an amount of money available immediately and larger amount of money available after a specified delay (1 day to 25 years). A computerized algorithm adjusts the immediately available reward across seven trials to determine an indifference point (k) for each amount/delay pairing. Indifference points are then used to calculate a rate of delay discounting for a $50, $200, $1,000 "larger later" sum. Larger scores mean greater delay discounting. While there is no strict minimum or maximum k-value, but in practical research settings, typical k-values often range from close to 0 for individuals who discount delayed rewards very slowly to values above 1 for those who heavily discount delayed rewards. There is no strict lower or upper bound, but values can be extremely high (above 1) if an individual very strongly prefers immediate rewards.
Measured: Baseline, Post-treatment, 1 month follow up
Timeline Follow-Back (TLFB): Number of Total Cigarettes Smoked Per Week
The Timeline Follow-Back (TLFB) for cigarette smoking is a self-report method used to assess an individual's smoking behavior over a specified period and specified as one week for this study. In this method, individuals are guided to recall their daily cigarette use by referencing events, routines, and cues that help them accurately track their smoking patterns. They are asked to document the number of cigarettes smoked each day, which provides a detailed, day-by-day account of their smoking habits. This data was then be summed to give a weekly total cigarettes smoked per week. The TLFB approach is valued for its reliability and ability to capture fluctuations in smoking behavior over time.
Measured: Baseline, Post-treatment, 1 month follow up
Carbon Monoxide Levels
Participant reports of abstinence will be verified by expired carbon monoxide (< 6 ppm cutoff for stated abstinence). CO levels are collected via a CO monitor.
Measured: Baseline, Post-treatment, 1 month follow up
Working Memory
Working memory was assessed by adding the scores of 3 different working memory measures: 1) the total achievement score in the Tower of Hanoi, 2) the total recall score of the Hopkins Verbal Learning Test- Revised and 3) the total scaled score of the Letter Number Sequencing. These measures are commonly used to assess working memory. In this study, the composite score of all measures ranged between 36 and 89 with higher scores representing greater working memory,
Measured: Baseline, Post-treatment, 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start30 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Tobacco Use Disorder/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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Anahi Collado, Principal investigator, KU-Lawrence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210608
- Sponsor's protocol ID
- STUDY00147684
- Other IDs
- 5KL2TR002367-05
- Acronym
- RTA
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2022
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remember to Abstain: Assessment of Working Memory Training on Delay Discounting in Low-SES Cigarette Smokers
- ClinicalTrials.gov ID
- NCT05210608
- Acronym / sponsor ID
- RTA / STUDY00147684
- Conditions
- Tobacco Use Disorder/Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite widespread awareness of significant negative health consequences, cigarette smoking remains the leading cause of preventable morbidity and mortality in the US (Creamer et al., 2019; Jamal, 2018). Moreover, the highest rate of smoking and heaviest burden of smoking-related illness occurs among low-socioeconomic status (SES) individuals relative to higher SES groups (Businelle et al., 2010; Clegg et al., 2009). Low SES individuals are also 40% less likely to succeed in quitting smoking when they attempt to do so (National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health, 2014). One potential explanation for the disparity in rate of smoking and successful quit attempts may be differences in individual rates of delay discounting (DD), i.e., the degree to which rewards loses their value as the delays to their receipt increase (Odum, 2011). A proposed way to reduce steep DD and, potentially, substance use has been computer training for working memory, which has shown favorable results in a sample of individuals with stimulant dependence (Bickel et al., 2011) and substance use broadly (Felton et al., 2019), with the latter even showing decreases in cigarette smoking in a subset of the sample.
Detailed description
The highest rate of smoking and heaviest burden of smoking-related illness occurs among low-SES individuals (Businelle et al., 2010; Clegg et al., 2009). One explanation for this disparity may be differences in individual rates of DD, which have been showed to be reduced with working memory training. (Bickel et al., 2011; Felton et al., 2019). Given the low cost of administering working memory training, such an intervention may be favorable for low-SES populations to improve smoking cessation outcomes.
DD has significant associations with:
Cigarette smoking (smokers tend to have higher rates of DD compared to non-smokers; Bickel et al., 1999);
Smoking treatment outcome (individuals who remained smoke free after a smoking cessation intervention had lower DD compared to those who didn't; González-Roz et al., 2019; Krishnan-Sarin et al., 2007; MacKillop \& Kahler, 2009; Yoon et al., 2007); SES (individuals with lower education and income have higher DD rates compared to those who are more educated and affluent; de Wit et al., 2007; Reimers et al., 2009).
An innovative way to reduce DD that has been proposed is via working memory (WM) training. WM refers to one's capacity to hold information while engaging in complex mental tasks, including reasoning, comprehension, and learning (Baddeley, 2010). Previous research has shown that DD and WM correlate negatively (Shamosh et al., 2008), that individuals with higher DD rates show neural deficits in WM (Herting et al., 2010), and that acute nicotine abstinence is associated with WM deficits (Mendrek et al., 2006; Patterson et al., 2010). Furthermore, previous studies targeting WM to reduce DD have shown favorable results in a sample of individuals with stimulant dependence (Bickel et al., 2011) and substance use broadly (Felton et al., 2019), with the latter even showing decreases in cigarette smoking in a subset of the sample.
Although previous research has shown WM training to reduce DD (which would support H3), and cigarette use in a small subsample, the hypotheses of this study are largely exploratory. However, given the theoretical connections between DD, SES, and WM, it is expected that the hypotheses of this project will be supported.
The performance of this project may advance our knowledge of the relevant clinical targets for smoking cessation in low-SES individuals. In particular, this project is expected to shed light on DD as the putative mechanism in smoking for low-SES individuals and the durability of reductions in smoking as a result of reductions in DD through WM training.
Despite the evidence for some successful techniques for reducing DD, little of this work has been translated into intervention approaches to target clinical outcomes. This application seeks to capitalize on the emerging literatures indicating (1) WM training may be an effective and efficient way to reduce DD, and (2) DD is associated with SES, cigarette smoking, and treatment outcomes. Though WM training has been successfully implemented in laboratory-controlled experiments to reduce DD, we are not aware of any interventions for clinical disorders that specifically seek to do so and potentially enhance treatment outcomes.
The development of effective, theoretically coherent interventions addressing cigarette smoking is imperative, particularly interventions that would be feasible, efficacious, and acceptable in low-SES individuals. The proposed research is an innovative approach that capitalizes on previous findings showing reductions in delay discounting and even cigarette smoking. If working memory training is found to improve smoking cessation outcomes as a function of reductions in delay discounting, the project results could be helpful in future development of low-cost interventions for cigarette smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Working Memory Training + Behavioral Intervention | Experimental | Behavioral: Working Memory Training + Behavioral InterventionParticipants will complete 10 sessions of a Working Memory Training. All participants will receive behavioral activation (a behavioral intervention for smoking cessation) and nicotine patches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Working Memory Training + Behavioral InterventionParticipants will be randomized to complete 10 sessions of a Working Memory Training. All participants will receive behavioral activation (a behavioral intervention for smoking cessation) and nicotine patches. | Behavioural | Working Memory Training + Behavioral Intervention |
Primary outcome
Delay Discounting
Time frame: Baseline, Post-treatment, 1 month follow up
Delay Discounting (DD) was measured via an established computerized binary choice task in which participants choose between an amount of money available immediately and larger amount of money available after a specified delay (1 day to 25 years). A computerized algorithm adjusts the immediately available reward across seven trials to determine an indifference point (k) for each amount/delay pairing. Indifference points are then used to calculate a rate of delay discounting for a $50, $200, $1,000 "larger later" sum. Larger scores mean greater delay discounting. While there is no strict minimum or maximum k-value, but in practical research settings, typical k-values often range from close to 0 for individuals who discount delayed rewards very slowly to values above 1 for those who heavily discount delayed rewards. There is no strict lower or upper bound, but values can be extremely high (above 1) if an individual very strongly prefers immediate rewards.
Timeline Follow-Back (TLFB): Number of Total Cigarettes Smoked Per Week
Time frame: Baseline, Post-treatment, 1 month follow up
The Timeline Follow-Back (TLFB) for cigarette smoking is a self-report method used to assess an individual's smoking behavior over a specified period and specified as one week for this study. In this method, individuals are guided to recall their daily cigarette use by referencing events, routines, and cues that help them accurately track their smoking patterns. They are asked to document the number of cigarettes smoked each day, which provides a detailed, day-by-day account of their smoking habits. This data was then be summed to give a weekly total cigarettes smoked per week. The TLFB approach is valued for its reliability and ability to capture fluctuations in smoking behavior over time.
Carbon Monoxide Levels
Time frame: Baseline, Post-treatment, 1 month follow up
Participant reports of abstinence will be verified by expired carbon monoxide (< 6 ppm cutoff for stated abstinence). CO levels are collected via a CO monitor.
Working Memory
Time frame: Baseline, Post-treatment, 1 month follow up
Working memory was assessed by adding the scores of 3 different working memory measures: 1) the total achievement score in the Tower of Hanoi, 2) the total recall score of the Hopkins Verbal Learning Test- Revised and 3) the total scaled score of the Letter Number Sequencing. These measures are commonly used to assess working memory. In this study, the composite score of all measures ranged between 36 and 89 with higher scores representing greater working memory,
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Anahi Collado principal investigator
KU-Lawrence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working Memory Training + Behavioral Intervention in people with Tobacco Use Disorder/Cigarette Smoking, run by University of Kansas Medical Center 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?
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 Feb 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?
Yes. Results are posted in the registry (first posted 24 Feb 2025). 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?
Delay Discounting (time frame: Baseline, Post-treatment, 1 month follow up). The study lists 4 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 24 Feb 2025.