Tobacco SmokingNCT05306158
Dual Use Approach Bias Training for Nicotine Addiction
A study testing CC+ECIG Condition and CC Condition in people with Tobacco Smoking and Electronic Cigarette Use, run by University of Houston at 1 site in United States.
Trial summary
The present project will evaluate the initial efficacy of approach bias retraining among dual combustible cigarette (CC) and electronic cigarette (ECIG) users. The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking, Electronic Cigarette Use, Substance Use
- What is being tested?
- CC+ECIG Condition and CC Condition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 30 Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- At least 15 days of CC use for the previous month
- ECIG use with nicotine at least 15 days for the previous month
- Motivation to quit nicotine (BOTH CC and ECIG; ≥ 5 on a 0-10 scale)
- Ability to speak and read English fluently
- Not have decreased number of cigarettes by more than half in the past month
- Own an android smartphone (for EMA).
Who cannot join
- Current psychotherapy or pharmacotherapy for mental illness or addiction
- Current use of nicotine replacement therapy, Zyban, or Chantix
- Limited mental capacity or inability to provide informed consent
- Insufficient command of the English language (>6th grade English literacy level required)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Approach Bias Retraining for Nicotine Addiction Among Dual Combustible and Electronic Cigarette Users
The present project will evaluate the initial efficacy of approach bias retraining among dual combustible cigarette (CC) and electronic cigarette (ECIG) users. The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining.
Read the detailed description
The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining. Participants will be randomized to one of three approach bias retraining conditions: (1) CC+ECIG; (2) CC only; or (3) sham (control). Participants will complete a phone pre-screener, baseline (week 1 of study participation), 4 approach bias retraining sessions in laboratory (with quit day scheduled for the 4th session; weeks 2-5 of study participation), and follow-up assessments at 4- and 6-weeks post-intervention (i.e., weeks 9 and 11 of study participation, respectfully). Participants also will complete ecological momentary assessments (EMA) of CC smoking, ECIG use, and CC and ECIG urges/cravings for 14 days post-intervention (i.e., weeks 5-7 of study participation) on Internet capable smartphones. The only time data will be collected is when participants complete EMA assessments or follow up surveys using the REDCap app on the smartphone.
- Conditions
- Tobacco Smoking, Electronic Cigarette Use, Substance Use
- Being tested
- CC+ECIG Condition, CC Condition, Sham Condition
- Medical subject headings
- Tobacco Smoking, Vaping, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC+ECIG ConditionOther
Participants will push CC- and ECIG-related pictures.
CC ConditionOther
Participants will push CC-related images and push and pull ECIG-related pictures equally often.
Sham ConditionOther
Also called Control
Participants will pull and push CC- and ECIG-related pictures equally often.
| Study group | Role | What they receive |
|---|---|---|
| CC+ECIG Condition | Experimental | Combustible Cigarette (CC) and Electronic Cigarette (ECIG) users will be trained to avoid CC and ECIG-related images and approach positive images. Receives: Other: CC+ECIG Condition |
| CC Only Condition | Active comparator | Participants in this arm will be trained to avoid only combustible cigarette images, not electronic cigarettes images. Receives: Other: CC Condition |
| Sham Condition | Sham comparator | Participants will pull and push all pictures of CC and ECIG images equally with no preference towards one or the other. Receives: Other: Sham Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically-Verified Point Prevalence Abstinence
Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG)
Measured: Week 9 of participation
Prolonged Abstinence
Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG)
Measured: Week 9 of participation
Lapse
Time to first use (CC and/or ECIG)
Measured: Week 9 of participation
Nicotine Relapse
7th day on which CC or ECIG occurs
Measured: Week 9 of participation
Secondary outcomes (7)
Questionnaire of Smoking Urges-Brief (QSU-Brief)
The Brief Questionnaire of Smoking Urges (QSU-Brief) consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now).
Measured: Week 1-7, 9, and 11 of participation
Questionnaire of Vaping Craving
The Questionnaire of Vaping Craving is a modified measure of the QSU and consists of 10 statements about the respondent's feelings and thoughts about his or her desire to vape as he or she is completing the questionnaire (i.e., right now).
Measured: Week 1-7, 9, and 11 of participation
Approach Bias
The approach-avoidance task (AAT) is a 15-minute computerized task instructs participants to use a joystick to either pull toward themselves or push away from themselves images presented on the screen that vary in content (i.e., substance-related, neutral, positive) and format (e.g., right- or left-tilted).
Measured: Weeks 2-5 of participation
Biochemically-Verified Point Prevalence Abstinence
Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG)
Measured: Week 11 of participation
Prolonged Abstinence
Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG)
Measured: Week 11 of participation
Lapse
Time to first use (CC and/or ECIG)
Measured: Week 11 of participation
Nicotine Relapse
7th day on which CC or ECIG occurs
Measured: Week 11 of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start3 Oct 2022
- Primary completion30 Sep 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies 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
- Model description
- There are three arms, one intervention (CC+ECIG Condition), one active comparator (CC Condition), and one Sham (control) arm which are randomly assigned at the same time (baseline) and are implemented in parallel.
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorra Garey, University of Houston
- Investigators
- Lorra Garey, Ph.D, Principal investigator, Assistant Research Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306158
- Sponsor's protocol ID
- PAR-19-309
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will provide de-identified data from this project to interested individuals one year following achievement of the aims of the project (i.e., publication of the main outcome paper). These data will be provided in digital format (i.e., disk) with clear labels for all variables. Data will be released directly by the investigators providing evidence of their institution's IRB approval for planned analyses of the data. Our team will be available to address queries.
Publications
Clausen B, Rinck M, Nizio P, Matoska CT, Zappi C, Smits JAJ, Gallagher MW, Zvolensky MJ, Garey L. Study protocol for approach bias retraining for nicotine addiction among dual combustible and electronic cigarette users. Contemp Clin Trials. 2023 May;128:107145. doi: 10.1016/j.cct.2023.107145. Epub 2023 Mar 9.
PubMed 36905980
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approach Bias Retraining for Nicotine Addiction Among Dual Combustible and Electronic Cigarette Users
- ClinicalTrials.gov ID
- NCT05306158
- Acronym / sponsor ID
- PAR-19-309
- Conditions
- Tobacco Smoking, Electronic Cigarette Use, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 31 Mar 2022 (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.
The present project will evaluate the initial efficacy of approach bias retraining among dual combustible cigarette (CC) and electronic cigarette (ECIG) users. The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining.
Detailed description
The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining. Participants will be randomized to one of three approach bias retraining conditions: (1) CC+ECIG; (2) CC only; or (3) sham (control). Participants will complete a phone pre-screener, baseline (week 1 of study participation), 4 approach bias retraining sessions in laboratory (with quit day scheduled for the 4th session; weeks 2-5 of study participation), and follow-up assessments at 4- and 6-weeks post-intervention (i.e., weeks 9 and 11 of study participation, respectfully). Participants also will complete ecological momentary assessments (EMA) of CC smoking, ECIG use, and CC and ECIG urges/cravings for 14 days post-intervention (i.e., weeks 5-7 of study participation) on Internet capable smartphones. The only time data will be collected is when participants complete EMA assessments or follow up surveys using the REDCap app on the smartphone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are three arms, one intervention (CC+ECIG Condition), one active comparator (CC Condition), and one Sham (control) arm which are randomly assigned at the same time (baseline) and are implemented in parallel.
| Arm | Type | Receives |
|---|---|---|
| CC+ECIG Condition | Experimental | Other: CC+ECIG ConditionCombustible Cigarette (CC) and Electronic Cigarette (ECIG) users will be trained to avoid CC and ECIG-related images and approach positive images. |
| CC Only Condition | Active comparator | Other: CC ConditionParticipants in this arm will be trained to avoid only combustible cigarette images, not electronic cigarettes images. |
| Sham Condition | Sham comparator | Other: Sham ConditionParticipants will pull and push all pictures of CC and ECIG images equally with no preference towards one or the other. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age
- At least 15 days of CC use for the previous month
- ECIG use with nicotine at least 15 days for the previous month
- Motivation to quit nicotine (BOTH CC and ECIG; ≥ 5 on a 0-10 scale)
- Ability to speak and read English fluently
Key exclusion criteria (4 listed)
- Current psychotherapy or pharmacotherapy for mental illness or addiction
- Current use of nicotine replacement therapy, Zyban, or Chantix
- Limited mental capacity or inability to provide informed consent
- Insufficient command of the English language (>6th grade English literacy level required)
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 |
|---|---|---|
| CC+ECIG ConditionParticipants will push CC- and ECIG-related pictures. | Other | CC+ECIG Condition |
| CC ConditionParticipants will push CC-related images and push and pull ECIG-related pictures equally often. | Other | CC Only Condition |
| Sham ConditionAlso: ControlParticipants will pull and push CC- and ECIG-related pictures equally often. | Other | Sham Condition |
Primary outcome
Biochemically-Verified Point Prevalence Abstinence
Time frame: Week 9 of participation
Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG)
Prolonged Abstinence
Time frame: Week 9 of participation
Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG)
Lapse
Time frame: Week 9 of participation
Time to first use (CC and/or ECIG)
Nicotine Relapse
Time frame: Week 9 of participation
7th day on which CC or ECIG occurs
7 secondary outcomes
Questionnaire of Smoking Urges-Brief (QSU-Brief)
Time frame: Week 1-7, 9, and 11 of participation
Questionnaire of Vaping Craving
Time frame: Week 1-7, 9, and 11 of participation
Approach Bias
Time frame: Weeks 2-5 of participation
Biochemically-Verified Point Prevalence Abstinence
Time frame: Week 11 of participation
Prolonged Abstinence
Time frame: Week 11 of participation
Lapse
Time frame: Week 11 of participation
Nicotine Relapse
Time frame: Week 11 of participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 36905980Clausen B, Rinck M, Nizio P, Matoska CT, Zappi C, Smits JAJ, Gallagher MW, Zvolensky MJ, Garey L. Study protocol for approach bias retraining for nicotine addiction among dual combustible and electronic cigarette users. Contemp Clin Trials. 2023 May;128:107145. doi: 10.1016/j.cct.2023.107145. Epub 2023 Mar 9.
- Individual participant dataSharing planned: Yes. We will provide de-identified data from this project to interested individuals one year following achievement of the aims of the project (i.e., publication of the main outcome paper). These data will be provided in digital format (i.e., disk) with clear labels for all variables. Data will be released directly by the investigators providing evidence of their institution's IRB approval for planned analyses of the data. Our team will be available to address queries.
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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.
Lorra Garey, Ph.D principal investigator
Assistant Research Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CC+ECIG Condition and CC Condition in people with Tobacco Smoking and Electronic Cigarette Use, run by University of Houston 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 7 inclusion and 4 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 27 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biochemically-Verified Point Prevalence Abstinence (time frame: Week 9 of participation). 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?
On the ClinicalTrials.gov record for NCT05306158, which also lists 1 linked publication.
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 27 Mar 2025.