Shaping Habitual Impulses For a Tobacco-free Style (SHIFTS)

University of Houston

Status: Not yet enrolling

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

Treatments: Behavioral: ST+ABR; Behavioral: ST+Sham; Behavioral: ST Only

Study type: Interventional

Funder types: Other

Identifiers

NCT07025772

STUDY00005124

RP250418 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

ST+ABR

Experimental group

Description:

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.

Treatment:

Behavioral: ST+ABR

ST+Sham

Sham Comparator group

Description:

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.

Treatment:

Behavioral: ST+Sham

ST Only

Other group

Description:

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.

Treatment:

Behavioral: ST Only