Using high-level thinking to help smokers quit
High-level Construal as a Novel Pathway for Affect Regulation and Cancer Control
This study is testing if a new way of thinking can help low-income adults who smoke quit for good.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Sponsor | University of Oregon Academic / other |
| Locations | 2 sites (Eugene, Oregon and 1 other locations) |
| Trial ID | NCT04620915 on ClinicalTrials.gov |
What this trial studies
This research aims to explore how high-level construal, a cognitive process, can aid in smoking cessation among low-income adult smokers who have previously struggled to quit. The study will involve 300 participants who will undergo assessments of their neural and behavioral responses to different interventions, including high-level construal and craving regulation. Participants will be randomized into three groups to evaluate the effectiveness of these approaches on smoking behavior and brain activation patterns. The findings could provide insights into the neurocognitive mechanisms that support smoking cessation efforts.
Who should consider this trial
Good fit: Ideal candidates are adult smokers aged 25-55 from low socioeconomic backgrounds who smoke at least 10 cigarettes a day and have previously attempted to quit.
Not a fit: Patients who do not smoke or those who have not expressed a desire to quit smoking may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a novel strategy for helping low-income smokers quit, potentially improving their health outcomes.
How similar studies have performed: While the specific approach of using high-level construal for smoking cessation is novel, similar cognitive strategies have shown promise in other behavioral interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Low-SES 2. Persistent smokers: cigarette smokers (at least 10 cigarettes/day for at least 1 year) 3. Want to quit but have tried and failed at least once 4. Income-to-needs ratio (INR) is less than 2.0, meaning that their household income adjusted for household size is below 200% of the federal poverty line 5. Ages 25-55 Scan Exclusion Criteria: 1. Metal implants (e.g., braces, permanent retainers, pins) 2. Metal fragments, pacemakers or other electronic medical implants 3. Claustrophobia 4. Weight ˃ 550 lbs. 5. Women who are pregnant or believe they might be pregnant People in this population are likely to have some comorbid psychiatric, substance use, and/or other health disorders that might pose a challenge to retention and intervention compliance. Such comorbidities are inherent to the population of interest (persistent smokers) so they will not be exclusionary criteria; instead, we will gather information about psychiatric, substance use, and medical comorbidities on intake so that we can monitor and report any associations with attrition, compliance, and effects of the experimental conditions. E-cigarette use is acceptable - it is not an exclusionary criterion - but it will be recorded and covaried as appropriate in the analyses. To increase the homogeneity of the sample in terms of cessation aids, we require that all participants use pharmacological cessation aids such as nicotine replacement therapy (NRT). This inclusion criterion also more realistically models how cessation happens in vivo, as medical care providers often recommend adding pharmacological assistance such as NRT to quit programs. We will provide patches or gum (e.g., Nicoderm) to participants who cannot afford. Participants who want or are able to provide their own NRT will be included as long as they agree to continue using NRT for the duration of the training period. We will monitor NRT use weekly to ensure compliance with this inclusion criterion. No exclusions will be made on gender, race, or ethnicity, so the sample will reflect the demographic profile of the United States. Eligible participants will be scheduled for the Zoom pre-session.
Where this trial is running
Eugene, Oregon and 1 other locations
- University of Oregon, Lewis Integrative Sciences Building — Eugene, Oregon, United States (Recruiting)
- University of Oregon, Social and Affective Neuroscience Laboratory — Eugene, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Elliot T Berkman, Ph.D. — University of Oregon
- Study coordinator: Elliot T Berkman, Ph.D.
- Email: berkman@uoregon.edu
- Phone: 541-346-4909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.