- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05210608
Working Memory Training on Delay Discounting Among Cigarette Smokers (RTA)
Remember to Abstain: Assessment of Working Memory Training on Delay Discounting in Low-SES Cigarette Smokers
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64130
- Swope Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Working Memory Training + Behavioral Intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, Post-treatment, 1 month follow up
|
|
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.
|
Baseline, Post-treatment, 1 month follow up
|
|
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.
|
Baseline, Post-treatment, 1 month follow up
|
|
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,
|
Baseline, Post-treatment, 1 month follow up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anahi Collado, KU-Lawrence
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00147684
- 5KL2TR002367-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Tobacco Use Disorder/Cigarette Smoking
-
Abramson Cancer Center at Penn MedicineNational Cancer Institute (NCI); University of Pennsylvania; Food and Drug Administration...Completed
-
Virginia Polytechnic Institute and State UniversityMedical University of South Carolina; National Cancer Institute (NCI)RecruitingCigarette Smoking | E-cigarette UseUnited States
-
Pok Oi HospitalNot yet recruitingSmoking ( Cigarette)Hong Kong
-
Ataturk UniversityCompleted
-
Masonic Cancer Center, University of MinnesotaNational Institute on Drug Abuse (NIDA)Active, not recruitingSmoking, CigaretteUnited States
-
RAI Services CompanyIPSOSCompletedSmoking CigaretteUnited Kingdom
-
Yasmeen Alaa Abd El-Hamied AhmeedCompleted
-
RANDCompletedSmoking, CigaretteUnited States
-
Virginia Polytechnic Institute and State UniversityActive, not recruitingCigarette Smoking Behavior | Smoking Behaviors | CigaretteUnited States
-
Brown UniversityNational Institute on Drug Abuse (NIDA)CompletedElectronic Cigarette Use | Smoking, CigaretteUnited States
Clinical Trials on Working Memory Training + Behavioral Intervention
-
St. Jude Children's Research HospitalAmerican Cancer Society, Inc.CompletedAcute Lymphoblastic Leukemia | Brain TumorUnited States
-
Wayne State UniversityRecruitingBehavior, HealthUnited States
-
University of GeorgiaRecruitingSchizophrenia | Schizo Affective DisorderUnited States
-
Milwaukee VA Medical CenterCompletedPosttraumatic Stress DisorderUnited States
-
KU LeuvenActive, not recruitingCerebral PalsyBelgium
-
Radboud University Medical CenterNetherlands Organisation for Scientific ResearchCompletedAttention Deficit Disorder With HyperactivityNetherlands
-
Norwegian University of Science and TechnologyCompletedInfant, Very Low Birth WeightNorway
-
University of MichiganTerminated
-
University of WaterlooCompleted