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NCT Number: NCT07025772

Shaping Habitual Impulses For a Tobacco-free Style

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.

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Key information

Conditions

ST+ABR Behavior Health Behavior ST+SHAM ST-only Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Houston, Texas, 77004, United States

Location status: Recruiting

Location contact

Ashley Ruiz, BS

CONTACT

[email protected]

713-743-8056

Lorra Garey, PhD

CONTACT

[email protected]

713-743-8056

Lorra Garey, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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)

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)
  • 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)

Treatment and study plan

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+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 Only

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Ruiz, B.S.

CONTACT

[email protected]

713-743-8056

Lorra Garey, PhD

CONTACT

[email protected]

713-743-8056

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • University of Texas at Austin

Registry information

Official study title

Approach Bias Retraining to Augment Long-Term Smoking Cessation Among a Diverse Sample

Acronym: SHIFTS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 17, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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