M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT02224391
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive ABM training via a smartphone
Correlative studies
Given via transdermal patch
Other names: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch
Ancillary studies
Undergo sham training
Time frame: Up to 8 weeks post-training
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.
Time frame: Up to 8 weeks post-training
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.
Time frame: Up to 8 weeks post-training
Mean number of cigarettes per day smoked for the seven days preceding each time point.
Time frame: Up to 8 weeks post-training
Mean expired carbon monoxide, in ppm (parts per million), at each time point.
Time frame: Up to 8 weeks post-training
Mean urinary cotinine, measured in ng/mL, at each time point.
Time frame: Up to 8 weeks post-training
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.
Time frame: Up to 8 weeks post-training
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.
M.D. Anderson Cancer Center
Other
Smartphone-Delivered Attentional Bias Modification Training for Quitting Smokers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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