NCT05210608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

February 24, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

January 14, 2022

Results QC Date

August 3, 2023

Last Update Submit

February 21, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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,

    Baseline, Post-treatment, 1 month follow up

Study Arms (1)

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.

Behavioral: Working Memory Training + Behavioral Intervention

Interventions

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.

Working Memory Training + Behavioral Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • $12,880
  • $17,420
  • $21,960
  • $26,500
  • $31,040
  • $35,580
  • $40,120
  • $44,660
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swope Health Center

Kansas City, Missouri, 64130, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderCigarette Smoking

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersTobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Anahi Collado, Assistant Research Professor
Organization
University of Colorado-Boulder

Study Officials

  • Anahi Collado

    KU-Lawrence

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

November 30, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

February 24, 2025

Results First Posted

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations