E-cigarette UseNCT05112562
Attentional Bias Modification Training for E-cigarette Users
A study testing Computerized attentional bias modification training in people with E-cigarette Use and Tobacco Use Cessation, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
Aims are to (1) evaluate attentional bias to e-cigarette cues between the intervention and control groups at post-intervention as compared to the pre-intervention; and (2) test the feasibility and efficacy of the intervention at post-intervention. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- E-cigarette Use, Tobacco Use Cessation
- What is being tested?
- Computerized attentional bias modification training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 and 29 years
- Those who use ENDS exclusively, not combining with other tobacco, for 3 consecutive months
- Those who own a smartphone.
Who cannot join
- Current medication or psychosocial treatment for ENDS dependence
- Serious alcohol-use problems (≥ 26 points on the Alcohol Use Disorders Identification Test)
- Ophthalmic conditions impeding eye-tracking
- Current psychiatric/psychosocial treatment for other mental health disorders in the DSM-5 (e.g., schizophrenia)
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Han Joo Lee, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, 53211
Seok Hyun Gwon, PhD, RN, 414-229-6462, gwon@uwm.edu
Han Joo Lee, PhD, leehj@uwm.edu
About this study
Aims are to (1) evaluate attentional bias to e-cigarette cues between the intervention and control groups at post-intervention as compared to the pre-intervention; and (2) test the feasibility and efficacy of the intervention at post-intervention. To accomplish these aims, a theory-driven parallel, controlled 2-arm randomized clinical trial will be conducted with young adult e-cigarette users (approximately N = 50). Outcomes are attentional bias to e-cigarette cues and abstinence outcomes including nicotine dependence, and arousal/urges for e-cigarette use.
- Conditions
- E-cigarette Use, Tobacco Use Cessation
- Being tested
- Computerized attentional bias modification training, Placebo attention control training
- Medical subject headings
- Vaping, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized attentional bias modification trainingBehavioural
In intervention is designed to train participants to disengage attention from potent e-cigarette cues and is based on the well-established attention retraining paradigm for other psychopathologies.
Placebo attention control trainingBehavioural
This control training is very similar to the intervention's overall task structure and stimuli. The only difference is that the this control program is designed to exert no systematic manipulation on the attention deployment pattern between the two stimulus categories, thereby yielding no significant impact on the level of attentional bas toward ENDS-related cues
| Study group | Role | What they receive |
|---|---|---|
| Computerized attentional bias modification training | Experimental | Not described Receives: Behavioral: Computerized attentional bias modification training |
| Placebo attention control training | Placebo comparator | Not described Receives: Behavioral: Placebo attention control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional bias to e-cigarette cues measured by cueing task
Attentional bias measured by time in milliseconds between cue and response in cueing task
Measured: Pre-training
Attentional bias to e-cigarette cues measured by cueing task
Attentional bias measured by time in milliseconds between cue and response in cueing task
Measured: 1-month follow up
Attentional bias to e-cigarette cues measured by cueing task
Attentional bias measured by time in milliseconds between cue and response in cueing task
Measured: 2-months follow up
Attentional bias to e-cigarette cues measured by cueing task
Attentional bias measured by time in milliseconds between cue and response in cueing task
Measured: 4-months follow up
Secondary outcomes (8)
Subjective urges for e-cigarette use
Subjective urges for ENDS use measured by E-cigarette Use Patterns questionnaire)
Measured: Pre-training
Nicotine dependence
Nicotine dependence measured by Penn State E-Cigarette Dependence Index
Measured: Pre-training
Subjective urges for e-cigarette use
Subjective urges for ENDS use measured by E-cigarette Use Patterns questionnaire)
Measured: 1-momnth follow up
Nicotine dependence
Nicotine dependence measured by Penn State E-Cigarette Dependence Index
Measured: 1-month follow up
Subjective urges for e-cigarette use
Subjective urges for ENDS use measured by E-cigarette Use Patterns questionnaire)
Measured: 2-momnth follow up
Nicotine dependence
Nicotine dependence measured by Penn State E-Cigarette Dependence Index
Measured: 2-month follow up
Subjective urges for e-cigarette use
Subjective urges for ENDS use measured by E-cigarette Use Patterns questionnaire)
Measured: 4-momnth follow up
Nicotine dependence
Nicotine dependence measured by Penn State E-Cigarette Dependence Index
Measured: 4-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start9 Jun 2021
- Primary completion31 May 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-cigarette UseStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seok Hyun Gwon, PhD, RN, Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112562
- Sponsor's protocol ID
- 20.172
- Status last verified
- Nov 2022
- First submitted
- 22 Sep 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentional Bias Modification Training for E-cigarette Users
- ClinicalTrials.gov ID
- NCT05112562
- Acronym / sponsor ID
- 20.172
- Conditions
- E-cigarette Use, Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims are to (1) evaluate attentional bias to e-cigarette cues between the intervention and control groups at post-intervention as compared to the pre-intervention; and (2) test the feasibility and efficacy of the intervention at post-intervention. To accomplish these aims, a theory-driven parallel, controlled 2-arm randomized clinical trial will be conducted with young adult e-cigarette users (approximately N = 50). Outcomes are attentional bias to e-cigarette cues and abstinence outcomes including nicotine dependence, and arousal/urges for e-cigarette use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized attentional bias modification training | Experimental | Behavioral: Computerized attentional bias modification training |
| Placebo attention control training | Placebo comparator | Behavioral: Placebo attention control training |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 and 29 years
- Those who use ENDS exclusively, not combining with other tobacco, for 3 consecutive months
- Those who own a smartphone.
Key exclusion criteria (5 listed)
- Current medication or psychosocial treatment for ENDS dependence
- Serious alcohol-use problems (≥ 26 points on the Alcohol Use Disorders Identification Test)
- Ophthalmic conditions impeding eye-tracking
- Current psychiatric/psychosocial treatment for other mental health disorders in the DSM-5 (e.g., schizophrenia)
- Pregnancy.
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 |
|---|---|---|
| Computerized attentional bias modification trainingIn intervention is designed to train participants to disengage attention from potent e-cigarette cues and is based on the well-established attention retraining paradigm for other psychopathologies. | Behavioural | Computerized attentional bias modification training |
| Placebo attention control trainingThis control training is very similar to the intervention's overall task structure and stimuli. The only difference is that the this control program is designed to exert no systematic manipulation on the attention deployment pattern between the two stimulus categories, thereby yielding no significant impact on the level of attentional bas toward ENDS-related cues | Behavioural | Placebo attention control training |
Primary outcome
Attentional bias to e-cigarette cues measured by cueing task
Time frame: Pre-training
Attentional bias measured by time in milliseconds between cue and response in cueing task
Attentional bias to e-cigarette cues measured by cueing task
Time frame: 1-month follow up
Attentional bias measured by time in milliseconds between cue and response in cueing task
Attentional bias to e-cigarette cues measured by cueing task
Time frame: 2-months follow up
Attentional bias measured by time in milliseconds between cue and response in cueing task
Attentional bias to e-cigarette cues measured by cueing task
Time frame: 4-months follow up
Attentional bias measured by time in milliseconds between cue and response in cueing task
8 secondary outcomes
Subjective urges for e-cigarette use
Time frame: Pre-training
Nicotine dependence
Time frame: Pre-training
Subjective urges for e-cigarette use
Time frame: 1-momnth follow up
Nicotine dependence
Time frame: 1-month follow up
Subjective urges for e-cigarette use
Time frame: 2-momnth follow up
Nicotine dependence
Time frame: 2-month follow up
Subjective urges for e-cigarette use
Time frame: 4-momnth follow up
Nicotine dependence
Time frame: 4-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Han Joo Lee, PhD contact
Seok Hyun Gwon, PhD, RN principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized attentional bias modification training in people with E-cigarette Use and Tobacco Use Cessation, run by University of Wisconsin, Milwaukee 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seok Hyun Gwon, PhD, RN (414-229-6462, gwon@uwm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attentional bias to e-cigarette cues measured by cueing task (time frame: Pre-training). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2022.