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Recruiting NCT07025772

Shaping Habitual Impulses For a Tobacco-free Style

No phase Interventional ST+ABR ST+SHAM ST-only

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ST+ABR, ST+Sham, ST Only.
Who it may be relevant to
Registry conditions: ST+ABR, ST+SHAM, ST-only. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
  • Prolonged Abstinence (PA) [Time frame: 3-week post-quit, 1-, 3-, and 6-month follow-ups]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, — Houston

Identifiers

NCT: NCT07025772 · STUDY00005124 · RP250418

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗