Clinical trial NCT07025772: Shaping Habitual Impulses For a Tobacco-free Style
Official title: Approach Bias Retraining to Augment Long-Term Smoking Cessation Among a Diverse Sample
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ST+ABR
ST+SHAM
ST-only
Keywords: Approach bias retraining
smoking cessation
cognitive retraining
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
First posted: 2025-06-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

At least 18 years of age Ability to speak English fluently Ability to write in English fluently Smoke at least 5 cigarettes daily on average Smoke at least 5 cigarettes daily on average for the past year Motivated to quit smoking (≥ 5 on a 10-point scale) Willing to attend in-person visits Provide written informed consent, accepting study inclusion criteria and the randomized group assignment English literacy of 6th 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) Biochemical verification of smoking status with expired carbon monoxide (CO) levels of \>4 parts per million (PPM)

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)

Primary outcomes:
measure: 7-day Biochemically Verified Point Prevalence Abstinence (PPA)
timeFrame: [Time Frame: Baseline appointment through the 6-month follow-up, inclusive of every assessment (daily 2x EMAs for 4 weeks; 1-, 3-, and 6-month follow-ups)]
measure: Prolonged Abstinence (PA)
timeFrame: [Time Frame: Baseline appointment through the 6-month follow-up, inclusive of every assessment]
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment
state: Texas
Study officials:
References: