ST+ABRSHIFTSNCT07025772
Shaping Habitual Impulses For a Tobacco-free Style
A study testing ST+ABR and ST Only in people with ST+ABR and ST+SHAM, run by University of Houston at 1 site in United States.
Trial summary
The present investigation aims to assess the efficacy of an innovative and novel smoking cessation intervention that integrates approach bias retraining (ABR) and standard smoking cessation treatment (ST). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ST+ABR and ST Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Ability to speak English fluently
- Ability to read English fluently
- Ability to write in English fluently
- Biochemical verification of self-reported smoking status following minimum study specified smoking rate endorsement
- Motivated to quit smoking
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- Willing to attend in-person visits
- Provide written informed consent, accepting study inclusion criteria and the randomized group assignment
- English literacy of 7th grade or higher, as indicated by a score of 4 or greater on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)
Who cannot join
- Having used an e-cigarette in the past 3 months
- Having initiated any mental health therapy or pharmacotherapy within the past 3 months
- Being currently in therapy for substance abuse (including nicotine dependence)
- Being currently enrolled in any other studies at the RESTORE lab to help quit smoking
- Currently using any NRT or psychotherapy products for nicotine cessation
- Currently using Bupropion as a smoking cessation aid and antidepressant
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- Currently pregnant or planning to become pregnant
- Having high blood pressure that is not under control
- Having a heart attack within the past 2 weeks
- Having Visual impairments
- Hand-motoric impairments
- Currently suicidal or high suicide risk or current or past psychotic disorders of any type, bipolar disorder, schizophrenia or schizoaffective disorder, anorexia, bulimia assessed using the Mini Neuropsychiatric Interview
- Cognitive impairment, verified via a score of ≥8 on the Six-Item Cognitive Impairment Test (6-CIT)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment
Houston, Texas, 77004
Lorra Garey, PhD, 713-743-8056, llgarey@central.uh.edu
Ashley Ruiz, BS, 713-743-8056, alruiz3@central.uh.edu
About this study
Official title: Approach Bias Retraining to Augment Long-Term Smoking Cessation Among a Diverse Sample
The present investigation aims to assess the efficacy of an innovative and novel smoking cessation intervention that integrates approach bias retraining (ABR) and standard smoking cessation treatment (ST). Participants will be randomized to either: (1) standard smoking cessation treatment and approach bias retraining (ST+ABR); (2) ST+Sham; or (3) ST-only.
Read the detailed description
The study employs a randomized controlled design to follow 300 individuals who smoke cigarettes as they engage in a smoking quit attempt following standard smoking cessation treatment (ST). Participants will be randomized to one of three conditions: (1) ST+ABR; (2) ST+Sham; or (3) ST-only. Participants will complete a self-screener, baseline appointment, 7 weeks of smoking cessation treatment, combined with approach bias retraining (if applicable) in the laboratory (with the quit day scheduled for the 6th session), 2x daily ecological momentary assessments (EMAs) for 4-weeks following their quit day, and 1-, 3-, and 6-month follow-ups in the laboratory.
- Being tested
- ST+ABR, ST+Sham, ST Only
- Keywords
- Approach bias retraining, smoking cessation, cognitive retraining
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST+ABRBehavioural
ST+ABR participants will complete seven weekly sessions of 15 minutes of computerized training (ABR), followed by a 45-minute session of standard smoking cessation treatment (CBT+NRT). Participants will be instructed to pull or push a joystick depending on the tilt, which will be positive-related or smoking-related images.
ST+ShamBehavioural
ST+Sham participants will complete seven weekly sessions of 15 minute computerized control sessions (AAT), followed by a 45-minute session of standard smoking cessation treatment (CBT+NRT). Participants will be instructed to pull or push a joystick depending on the tilt, which will be positive-related or smoking-related images.
ST OnlyBehavioural
ST Only will consist of 7 weekly 45-minute sessions of standard treatment (CBT+NRT) for smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| ST+ABR | Experimental | ST+ABR is the combination of standard treatment (cognitive behavioral therapy [CBT]+ nicotine replacement therapy [NRT]) for smoking cessation based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use And Dependence and computerized Approach Bias Retraining (ABR) for smoking cessation. Receives: Behavioral: ST+ABR |
| ST+Sham | Sham comparator | ST+Sham is the combination of standard treatment (CBT+NRT) for smoking cessation based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use And Dependence and computerized Sham (Control) training. Receives: Behavioral: ST+Sham |
| ST Only | Other | ST Only will consist of standard treatment (CBT+NRT) for smoking cessation, based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use And Dependence. Receives: Behavioral: ST Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Biochemically Verified Point Prevalence Abstinence (PPA)
PPA will be defined as no cigarette smoking within the past 7 days of assessments and will be biochemically verified via assessment of expired carbon monoxide.
Measured: 1-week, 2-week, 3-week post-quit, and 1-, 3-, and 6-month follow-ups
Prolonged Abstinence (PA)
Participants will self report their abstinence by reporting whether or not they have smoked since their quit date following a 2-week grace period.
Measured: 3-week post-quit, 1-, 3-, and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start24 Mar 2026
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST+ABRStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Principal investigator, Lorra Garey, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025772
- Sponsor's protocol ID
- STUDY00005124
- Other IDs
- RP250418
- Acronym
- SHIFTS
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2025
- Last updated
- 17 Apr 2026
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approach Bias Retraining to Augment Long-Term Smoking Cessation Among a Diverse Sample
- ClinicalTrials.gov ID
- NCT07025772
- Acronym / sponsor ID
- SHIFTS / STUDY00005124
- Keywords
- Approach bias retraining, smoking cessation, cognitive retraining
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 17 Jun 2025 (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 investigation aims to assess the efficacy of an innovative and novel smoking cessation intervention that integrates approach bias retraining (ABR) and standard smoking cessation treatment (ST). Participants will be randomized to either: (1) standard smoking cessation treatment and approach bias retraining (ST+ABR); (2) ST+Sham; or (3) ST-only.
Detailed description
The study employs a randomized controlled design to follow 300 individuals who smoke cigarettes as they engage in a smoking quit attempt following standard smoking cessation treatment (ST). Participants will be randomized to one of three conditions: (1) ST+ABR; (2) ST+Sham; or (3) ST-only. Participants will complete a self-screener, baseline appointment, 7 weeks of smoking cessation treatment, combined with approach bias retraining (if applicable) in the laboratory (with the quit day scheduled for the 6th session), 2x daily ecological momentary assessments (EMAs) for 4-weeks following their quit day, and 1-, 3-, and 6-month follow-ups in the laboratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ST+ABR | Experimental | Behavioral: ST+ABRST+ABR is the combination of standard treatment (cognitive behavioral therapy [CBT]+ nicotine replacement therapy [NRT]) for smoking cessation based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use And Dependence and computerized Approach Bias Retraining (ABR) for smoking cessation. |
| ST+Sham | Sham comparator | Behavioral: ST+ShamST+Sham is the combination of standard treatment (CBT+NRT) for smoking cessation based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use And Dependence and computerized Sham (Control) training. |
| ST Only | Other | Behavioral: ST OnlyST Only will consist of standard treatment (CBT+NRT) for smoking cessation, based on the most recent clinical practice guideline from the U.S. Department of Health and Human Services, Treating Tobacco Use And Dependence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age
- Ability to speak English fluently
- Ability to read English fluently
- Ability to write in English fluently
- Biochemical verification of self-reported smoking status following minimum study specified smoking rate endorsement
Key exclusion criteria (13 listed)
- Having used an e-cigarette in the past 3 months
- Having initiated any mental health therapy or pharmacotherapy within the past 3 months
- Being currently in therapy for substance abuse (including nicotine dependence)
- Being currently enrolled in any other studies at the RESTORE lab to help quit smoking
- Currently using any NRT or psychotherapy products for nicotine cessation
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 |
|---|---|---|
| ST+ABRST+ABR participants will complete seven weekly sessions of 15 minutes of computerized training (ABR), followed by a 45-minute session of standard smoking cessation treatment (CBT+NRT). Participants will be instructed to pull or push a joystick depending on the tilt, which will be positive-related or smoking-related images. | Behavioural | ST+ABR |
| ST+ShamST+Sham participants will complete seven weekly sessions of 15 minute computerized control sessions (AAT), followed by a 45-minute session of standard smoking cessation treatment (CBT+NRT). Participants will be instructed to pull or push a joystick depending on the tilt, which will be positive-related or smoking-related images. | Behavioural | ST+Sham |
| ST OnlyST Only will consist of 7 weekly 45-minute sessions of standard treatment (CBT+NRT) for smoking cessation. | Behavioural | ST Only |
Primary outcome
7-day Biochemically Verified Point Prevalence Abstinence (PPA)
Time frame: 1-week, 2-week, 3-week post-quit, and 1-, 3-, and 6-month follow-ups
PPA will be defined as no cigarette smoking within the past 7 days of assessments and will be biochemically verified via assessment of expired carbon monoxide.
Prolonged Abstinence (PA)
Time frame: 3-week post-quit, 1-, 3-, and 6-month follow-ups
Participants will self report their abstinence by reporting whether or not they have smoked since their quit date following a 2-week grace period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ST+ABR and ST Only in people with ST+ABR and ST+SHAM, 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorra Garey, PhD (713-743-8056, llgarey@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day Biochemically Verified Point Prevalence Abstinence (PPA) (time frame: 1-week, 2-week, 3-week post-quit, and 1-, 3-, and 6-month follow-ups). 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?
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 17 Apr 2026.