Current Every Day SmokerNCT02224391
Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking
A study testing Computer-Assisted Smoking Cessation Intervention, Laboratory Biomarker Analysis and Nicotine Patch in people with Current Every Day Smoker, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Current Every Day Smoker
- What is being tested?
- Computer-Assisted Smoking Cessation Intervention, Laboratory Biomarker Analysis and Nicotine Patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 311 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2016to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone-Delivered Attentional Bias Modification Training for Quitting Smokers
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Current Every Day Smoker
- Being tested
- Computer-Assisted Smoking Cessation Intervention, Laboratory Biomarker Analysis, Nicotine Patch, Questionnaire Administration, Sham Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted Smoking Cessation InterventionBehavioural
Receive ABM training via a smartphone
Laboratory Biomarker AnalysisOther
Correlative studies
Nicotine PatchDrug
Also called NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch
Given via transdermal patch
Questionnaire AdministrationOther
Ancillary studies
Sham InterventionOther
Undergo sham training
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ABM training) | Experimental | Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks. Receives: Behavioral: Computer-Assisted Smoking Cessation Intervention; Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration |
| Arm II (sham training) | Sham comparator | Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks. Receives: Other: Laboratory Biomarker Analysis; Drug: Nicotine Patch; Other: Questionnaire Administration; Other: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks post-training
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.
Measured: Up to 8 weeks post-training
Secondary outcomes (5)
Cigarette Per Day (CPD)
Mean number of cigarettes per day smoked for the seven days preceding each time point.
Measured: Up to 8 weeks post-training
Expired Carbon Monoxide (CO)
Mean expired carbon monoxide, in ppm (parts per million), at each time point.
Measured: Up to 8 weeks post-training
Urinary Cotinine
Mean urinary cotinine, measured in ng/mL, at each time point.
Measured: Up to 8 weeks post-training
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.
Measured: Up to 8 weeks post-training
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.
Measured: Up to 8 weeks post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study start20 Jan 2016
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Current Every Day SmokerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jason Robinson, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224391
- Sponsor's protocol ID
- 2013-0999
- Other IDs
- NCI-2015-00609, 2013-0999
- Status last verified
- Mar 2023
- First submitted
- 21 Aug 2014
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Robinson JD, Cui Y, Engelmann JM, Kypriotakis G, Cinciripini PM. Using eye tracking to evaluate the impact of smartphone-delivered attentional bias modification training for smokers. Exp Clin Psychopharmacol. 2024 Dec;32(6):728-736. doi: 10.1037/pha0000729. Epub 2024 Jun 27.
PubMed 38934914Robinson JD, Cui Y, Linares Abrego P, Engelmann JM, Prokhorov AV, Vidrine DJ, Shete S, Cinciripini PM. Sustained reduction of attentional bias to smoking cues by smartphone-delivered attentional bias modification training for smokers. Psychol Addict Behav. 2022 Nov;36(7):906-919. doi: 10.1037/adb0000805. Epub 2022 Jan 13.
PubMed 35025555
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-Delivered Attentional Bias Modification Training for Quitting Smokers
- ClinicalTrials.gov ID
- NCT02224391
- Acronym / sponsor ID
- 2013-0999
- Conditions
- Current Every Day Smoker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ABM training) | Experimental | Behavioral: Computer-Assisted Smoking Cessation Intervention, Other: Laboratory Biomarker Analysis, Drug: Nicotine Patch, Other: Questionnaire AdministrationPatients 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 (sham training) | Sham comparator | Other: Laboratory Biomarker Analysis, Drug: Nicotine Patch, Other: Questionnaire Administration, Other: Sham InterventionPatients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-Assisted Smoking Cessation InterventionReceive ABM training via a smartphone | Behavioural | Arm I (ABM training) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (ABM training), Arm II (sham training) |
| Nicotine PatchAlso: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal PatchGiven via transdermal patch | Drug | Arm I (ABM training), Arm II (sham training) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (ABM training), Arm II (sham training) |
| Sham InterventionUndergo sham training | Other | Arm II (sham training) |
Primary outcome
Modified Dot-probe Task
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.
Smoking Stroop Task
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.
5 secondary outcomes
Cigarette Per Day (CPD)
Time frame: Up to 8 weeks post-training
Expired Carbon Monoxide (CO)
Time frame: Up to 8 weeks post-training
Urinary Cotinine
Time frame: Up to 8 weeks post-training
Fagerström Test for Nicotine Dependence (FTND)
Time frame: Up to 8 weeks post-training
Wisconsin Smoking Withdrawal Scale (WSWS) - Craving
Time frame: Up to 8 weeks post-training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38934914Robinson JD, Cui Y, Engelmann JM, Kypriotakis G, Cinciripini PM. Using eye tracking to evaluate the impact of smartphone-delivered attentional bias modification training for smokers. Exp Clin Psychopharmacol. 2024 Dec;32(6):728-736. doi: 10.1037/pha0000729. Epub 2024 Jun 27.
- Derived from this study: PubMed 35025555Robinson JD, Cui Y, Linares Abrego P, Engelmann JM, Prokhorov AV, Vidrine DJ, Shete S, Cinciripini PM. Sustained reduction of attentional bias to smoking cues by smartphone-delivered attentional bias modification training for smokers. Psychol Addict Behav. 2022 Nov;36(7):906-919. doi: 10.1037/adb0000805. Epub 2022 Jan 13.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Robinson, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Assisted Smoking Cessation Intervention, Laboratory Biomarker Analysis and Nicotine Patch in people with Current Every Day Smoker, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Dot-probe Task (time frame: Up to 8 weeks post-training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02224391, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.