Approach Bias Retraining for Smoking Cessation

(SHIFTS Trial)

Overseen By Ashley Ruiz, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Houston

Must not be taking: NRT, Bupropion

Disqualifiers: Pregnancy, Uncontrolled hypertension, Psychotic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people quit smoking. It combines standard treatments, such as counseling and nicotine patches, with a unique computer-based training called Approach Bias Retraining (ABR) to alter brain reactions to smoking cues. Participants may receive this combined treatment, only the standard treatment, or the standard treatment with a placebo computer training. It suits those who smoke at least five cigarettes daily and are motivated to quit. As an unphased trial, this study provides a unique opportunity to explore innovative methods for quitting smoking.

Do I have to stop taking my current medications to join the trial?

The trial requires that you are not currently using any nicotine replacement therapy, Bupropion, or psychotherapy products for smoking cessation. If you are using these, you would need to stop before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that approach bias retraining (ABR) is generally well-tolerated by individuals attempting to quit smoking. Studies suggest that ABR can help reduce cravings and the urge to smoke. This method trains the brain to resist smoking-related triggers, aiding in maintaining a smoke-free lifestyle.

ABR is used alongside standard treatments like cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT). These standard treatments have been safely used for a long time and are well understood. Together, they offer a comprehensive approach to quitting smoking.

Studies have not reported any major safety concerns with ABR. However, like any treatment, some individuals might experience minor side effects. Overall, combining ABR with standard methods appears to be a safe option for those wanting to quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Approach Bias Retraining (ABR) for smoking cessation because it adds a new layer to the standard treatment. While most smoking cessation methods rely on cognitive behavioral therapy (CBT) and nicotine replacement therapy (NRT), ABR introduces a computerized technique aimed at changing subconscious behaviors related to smoking. This method specifically targets the automatic tendencies people have to approach smoking-related cues, potentially making it easier for individuals to resist the urge to smoke. By addressing both the psychological and behavioral aspects of smoking, ABR could enhance the effectiveness of traditional therapies.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that combining approach bias retraining (ABR) with regular smoking treatments can help people quit smoking. In this trial, participants in the ST+ABR arm will receive ABR alongside standard treatments. A previous study found that individuals who used ABR with standard treatments were more likely to remain smoke-free three months after attempting to quit. ABR changes how the brain responds to smoking triggers, making it easier to avoid cigarettes. It reduces the urge to smoke and alters automatic habits that lead to smoking. Overall, ABR appears to enhance the success of quitting smoking compared to using standard treatments alone. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for smokers who want to quit, smoke at least 5 cigarettes daily for the past year, and are motivated to stop. They must be adults fluent in English with basic literacy, willing to attend visits, and have a CO level >4 PPM. Excluded are those with recent heart attacks or uncontrolled high blood pressure, certain mental health conditions or treatments, e-cigarette use in the last 3 months, pregnancy plans, hand impairments or visual impairments.

Inclusion Criteria

Biochemical verification of smoking status with expired carbon monoxide (CO) levels of >4 parts per million (PPM)

I am willing to go to the hospital or clinic for visits.

Smoke at least 5 cigarettes daily on average for the past year

Exclusion Criteria

I had a heart attack in the last 2 weeks.

I do not have a history of severe mental health issues, including suicidal thoughts.

My high blood pressure is not controlled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete a self-screener and baseline appointment

1 day

1 visit (in-person)

Treatment

Participants receive 7 weeks of smoking cessation treatment, with approach bias retraining if applicable

7 weeks

6 visits (in-person)

Ecological Momentary Assessment

Participants complete 2x daily ecological momentary assessments for 4 weeks following their quit day

4 weeks

Follow-up

Participants are monitored for smoking abstinence at 1-, 3-, and 6-month follow-ups

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ST+ABR
• ST Only
• ST+Sham

Trial Overview The study tests a new smoking cessation method combining standard treatment (ST) with approach bias retraining (ABR). Participants will be randomly assigned to one of three groups: ST+ABR; ST+Sham (a placebo-like intervention); or just ST. The goal is to see if adding ABR helps people quit smoking more effectively than the usual methods.

How Is the Trial Designed?

Group I: ST+ABR Experimental Treatment 1 Intervention

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.

Group II: ST Only Experimental Treatment 1 Intervention

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.

Group III: ST+Sham Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39259134/

Approach Bias and Tobacco Craving as Mechanisms of the ... Results indicate that reductions in approach bias partially mediate the effect of ABR on smoking abstinence.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10041775/

Approach bias retraining to augment smoking cessation Participants assigned to the integrated intervention evidenced significantly greater abstinence rates 3 months following their quit attempt ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03325777

Approach Bias Retraining to Augment Smoking Cessation Standard smoking cessation care (cognitive behavioral therapy and nicotine replacement therapy), is effective in approximately 20% of the cases, clearly ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871622003167

Approach bias retraining to augment smoking cessation Indeed, evidence suggests that improved smoking outcomes are present during training (Machulska et al., 2021) but likely diminish once training ...

5. academic.oup.com academic.oup.com/ntr/article-abstract/27/5/830/7754996

Approach Bias and Tobacco Craving as Mechanisms of the ... Results showed that lower approach bias and lower cravings at a treatment session were significantly related to the next session smoking abstinence (p's < .018) ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2451865418301595

Approach bias retraining to augment smoking cessation To assess, in a randomized clinical trial, the effects of ST + ABR vs. ST + CTRL on the following smoking cessation outcomes: Short- and long-term point ...

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00352-9/fulltext

Effectiveness of family-based behavioral intervention for ... We found that family-based behavioral counseling combined with nicotine replacement therapy and extended follow-up significantly improves cessation outcomes.