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Working Memory Training on Delay Discounting Among Cigarette Smokers (RTA)

Primary Purpose

Tobacco Use Disorder/Cigarette Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Working Memory Training (Active Intervention) + Behavioral Intervention
Control Training (CT) + Behavioral Intervention
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder/Cigarette Smoking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Swope Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Working Memory Training (Active Training) + Behavioral Intervention

Control Training (CT) + Behavioral Intervention

Arm Description

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.

Participants will be randomized to complete 10 sessions of a Control Condition Memory Training. All participants will receive behavioral activation (a behavioral intervention for smoking cessation) and nicotine patches.

Outcomes

Primary Outcome Measures

Delay Discounting
A 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, 1 week, 1 month, 6 months, 1 year, 5 years, 25 years).
Timeline Follow-Back
The Timeline Follow-up will be used to measure point prevalence of tobacco smoking.
Carbon Monoxide Levels
Participant reports of abstinence will be verified by expired carbon monoxide (< 6 ppm cutoff for stated abstinence).
Working Memory
A working memory index will be created using three different working memory measure: 1) the total achievement score in the Tower of Hanoi (TOH), 2) the total recall score of the Hopkins Verbal Learning Test- Revised (HVLT-R) and 3) the total scaled score of the Letter Number Sequencing (LNS).

Secondary Outcome Measures

Full Information

First Posted
January 14, 2022
Last Updated
July 6, 2022
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05210608
Brief Title
Working Memory Training on Delay Discounting Among Cigarette Smokers
Acronym
RTA
Official Title
Remember to Abstain: Assessment of Working Memory Training on Delay Discounting in Low-SES Cigarette Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder/Cigarette Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to the Computerized Working Memory Training or the Computerized Control Condition
Masking
Participant
Masking Description
Participants will not be told to which condition they were randomized.
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Working Memory Training (Active Training) + Behavioral Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Training (CT) + Behavioral Intervention
Arm Type
Active Comparator
Arm Description
Participants will be randomized to complete 10 sessions of a Control Condition Memory Training. All participants will receive behavioral activation (a behavioral intervention for smoking cessation) and nicotine patches.
Intervention Type
Behavioral
Intervention Name(s)
Working Memory Training (Active Intervention) + Behavioral Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Training (CT) + Behavioral Intervention
Intervention Description
Participants will be randomized to complete 10 sessions of a Control Condition Memory Training. All participants will receive behavioral activation (a behavioral intervention for smoking cessation) and nicotine patches.
Primary Outcome Measure Information:
Title
Delay Discounting
Description
A 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, 1 week, 1 month, 6 months, 1 year, 5 years, 25 years).
Time Frame
Baseline, Post-treatment, 1 month follow up
Title
Timeline Follow-Back
Description
The Timeline Follow-up will be used to measure point prevalence of tobacco smoking.
Time Frame
Pre-training, post-training, 1 week post-quit date, one-month post-quit date
Title
Carbon Monoxide Levels
Description
Participant reports of abstinence will be verified by expired carbon monoxide (< 6 ppm cutoff for stated abstinence).
Time Frame
Baseline, Post-treatment, 1- week post quit date session, 1 month follow up
Title
Working Memory
Description
A working memory index will be created using three different working memory measure: 1) the total achievement score in the Tower of Hanoi (TOH), 2) the total recall score of the Hopkins Verbal Learning Test- Revised (HVLT-R) and 3) the total scaled score of the Letter Number Sequencing (LNS).
Time Frame
Baseline, Post-treatment, 1 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anahi Collado
Organizational Affiliation
KU-Lawrence
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swope Health Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Working Memory Training on Delay Discounting Among Cigarette Smokers

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