Shaping Habitual Impulses For a Tobacco-free Style

Not Applicable

Not yet recruiting

• Conditions: ST+ABR; ST+SHAM; ST-only

• Registration Number: NCT07025772
• Lead Sponsor: University of Houston

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Start: 2025-08-01
• Primary Completion: 2027-08-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
7-day Biochemically Verified Point Prevalence Abstinence (PPA)	[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)]	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 (\<= 4ppm).
Prolonged Abstinence (PA)	[Time Frame: Baseline appointment through the 6-month follow-up, inclusive of every assessment]	Participants will self report their abstinence by reporting whether or not they have smoked since their quit date.

Trial Locations

Locations (1)

RESTORE Laboratory: Research on Emotion, Substance Use Treatment Outcomes, Rehabilitation, and Empowerment; 🇺🇸 Houston, Texas, United States