Shaping Habitual Impulses For a Tobacco-free Style

NCT ID: NCT07025772

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-12-01

Brief Summary

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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

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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.

Conditions

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ST+ABR ST+SHAM ST-only

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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ST+ABR

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.

Group Type EXPERIMENTAL

ST+ABR

Intervention Type 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+Sham

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.

Group Type SHAM_COMPARATOR

ST+Sham

Intervention Type 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 Only

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.

Group Type OTHER

ST Only

Intervention Type BEHAVIORAL

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

Interventions

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ST+ABR

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.

Intervention Type BEHAVIORAL

ST+Sham

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.

Intervention Type BEHAVIORAL

ST Only

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

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) 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 Cognitive impairment, verified via a score of \> 8 on the Six-Item Cognitive Impairment Test (6-CIT)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role collaborator

University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Lorra Garey

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Lorra Garey, PhD

Role: CONTACT

713-743-8056

Ashley Ruiz, B.S.

Role: CONTACT

713-743-8056

Facility Contacts

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Lorra Garey, PhD

Role: primary

713-743-8056

Ashley Ruiz, BS

Role: backup

713-743-8056

Other Identifiers

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RP250418

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00005124

Identifier Type: -

Identifier Source: org_study_id

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