Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking

Current Every Day Smoker Clinical Trial

Official title:

Smartphone-Delivered Attentional Bias Modification Training for Quitting Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224391
• Other study ID #: 2013-0999
• Secondary ID: NCI-2015-0060920
• Status: Completed
• Phase: N/A
• Start date: January 20, 2016
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial studies how well a smartphone-delivered attentional bias modification training works in helping patients quit smoking. Smartphone-delivered attentional bias modification training may help patients quit smoking by reducing the attentional bias (the tendency of one's perception to be affected by their recurring thoughts) towards smoking cues that developed over time as a result of conditioning processes through which smoking cues become important.

Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility of smartphone-delivered, in-home attentional bias modification (ABM) to reduce attentional bias (AB) to smoking cues and to reduce smoking behavior in the short- and long-term.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.

ARM II: Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.

After completion of study treatment, patients are followed up on days 15, 29, 43, 57, and 72.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Smoke an average of 5 or more cigarettes or little cigars per day (CPD) prior to telephone screen

• Produce an expired carbon monoxide (CO) level greater than or equal to 6 parts per million (ppm) or a NicAlert reading of > 2

• Have a working telephone

• Interested in quitting smoking in the next 30 days

• Fluency in spoken and written English

• Must sign the picture consent form

Exclusion Criteria:

• Taking psychotropic, anticonvulsive, or narcotic medication

• Meet criteria for a current major depressive episode or suicidality

• Have a history of neurological illness or closed head injury

• Report uncorrected vision problems

• Involved in current smoking cessation activity

• Testing positive on a urine drug screen for drugs of abuse/potential abuse

• Women who are pregnant or breastfeeding

• Considered by the investigator to be an unsuitable or unstable candidate (e.g., due to cognitive impairment)

• Shares the same address as a currently enrolled participant

• Unwilling to alter or remove hairstyle, hair extensions, or wig during the clinic visits to allow for correct electroencephalography (EEG) sensor placement

• Reports diagnosis of seizure disorder

• Unwilling to use nicotine replacement therapy (NRT) patches

Related Conditions & MeSH terms

• Current Every Day Smoker

Intervention

Behavioral:
• Computer-Assisted Smoking Cessation Intervention
Receive ABM training via a smartphone

Other:
• Laboratory Biomarker Analysis
Correlative studies

Drug:
• Nicotine Patch
Given via transdermal patch

Other:
• Questionnaire Administration
Ancillary studies
• Sham Intervention
Undergo sham training

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Dot-probe Task	Modified dot-probe task evaluated by using 2 (group: ABM vs. sham) X 3 (session: baseline, 1-day post-training, and 8-weeks post-training) linear mixed model using RT difference scores (neutral-cigarette) as the dependent measures and subject as the random effect.	Up to 8 weeks post-training
Primary	Smoking Stroop Task	The Stroop task will consist of three blocks, with a 5-s rest period between blocks: (a) practice (40 trials), (b) neutral words (80 trials), and (c) smoking words (80 trials). The score will be calculated by taking the mean RT difference between the smoking and neutral words on trials with correct responses within the response window.	Up to 8 weeks post-training
Secondary	Cigarette Per Day (CPD)	Mean number of cigarettes per day smoked for the seven days preceding each time point.	Up to 8 weeks post-training
Secondary	Expired Carbon Monoxide (CO)	Mean expired carbon monoxide, in ppm (parts per million), at each time point.	Up to 8 weeks post-training
Secondary	Urinary Cotinine	Mean urinary cotinine, measured in ng/mL, at each time point.	Up to 8 weeks post-training
Secondary	Fagerström Test for Nicotine Dependence (FTND)	The Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Mean Fagerström Test for Nicotine Dependence (FTND) questionnaire score at each time point.	Up to 8 weeks post-training
Secondary	Wisconsin Smoking Withdrawal Scale (WSWS) - Craving	Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal.	Up to 8 weeks post-training

External Links

•   MD Anderson Cancer Center