Shaping Habitual Impulses For a Tobacco-free Style

NCT07025772 | Recruiting

• 2 other identifiers: STUDY00005124RP250418
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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). Participants will be randomized to either: (1) standard smoking cessation treatment and approach bias retraining (ST+ABR); (2) ST+Sham; or (3) ST-only.

Conditions

ST+ABR; ST+SHAM; ST-only

Keywords

Approach bias retraining; smoking cessation; cognitive retraining

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3-week post-quit, 1-, 3-, and 6-month follow-ups

Study Arms (3)

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.

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.

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.

Behavioral: ST Only

Interventions

ST+ABR BEHAVIORAL

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+ABR

ST+Sham BEHAVIORAL

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+Sham

ST Only BEHAVIORAL

ST Only will consist of 7 weekly 45-minute sessions of standard treatment (CBT+NRT) for smoking cessation.

ST Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willing to attend in-person visits
• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Houston: lead
• University of Texas at Austin: collaborator

Study Sites (1)

RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment

Houston, Texas, 77004, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Lorra Garey, PhD

CONTACT

713-743-8056; llgarey@central.uh.edu

Ashley Ruiz, B.S.

CONTACT

713-743-8056; alruiz3@central.uh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: March 24, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)