An interventional study of Educational materials and Phone counseling in Smoking Cessation, sponsored by University of Florida. Recruiting at 1 site in Lebanon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by University of Florida · Not applicable, Interventional, and Prevention
The tobacco use burden in Lebanon is exceptionally high: 35% of adults are current cigarette smokers and 39% are current waterpipe smokers. Although the World Health Organization endorses evidence-based interventions for population-level tobacco dependence treatment, recommended treatments are not integrated as a routine part of primary care in Lebanon, as is the case in other low-resource settings. The objective of this proposal is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based cessation treatment in Lebanon's national system of primary health care centers.
The research team will conduct a group-randomized trial comparing three arms: 1) Ask about tobacco use, advise to quit, assist with brief counseling (AAA) as standard care; 2) Ask, advise, connect to phone-based counseling (AAC); and 3) AAC+ Nicotine Replacement Therapy (NRT). Our central hypothesis is that connecting patients to phone-based counseling with cessation medication is the most effective alternative. The hybrid design is informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework which emphasizes key steps and multilevel factors to optimize implementation success. The following specific aims will be pursued: 1) adapt and tailor an existing smoking cessation program to deliver phone-based counseling to smokers in Lebanon; 2) test the effectiveness and cost-effectiveness of a referral-based program that delivers smoking cessation services to primary care patients; and 3) identify the multilevel determinants of implementation and sustainability using mixed methods.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
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Exclusion Criteria:
All patients will be screened for tobacco use, and offer brief cessation advice and counseling.
Behavioral: Educational materials · Behavioral: Provider training · Behavioral: Electronic reminders
Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.
Behavioral: Educational materials · Behavioral: Phone counseling · Behavioral: Provider training · Behavioral: Electronic reminders
In addition to AAC, patients will be offered NRT.
Behavioral: Educational materials · Behavioral: Phone counseling · Drug: Nicotine Replacement Therapy · Behavioral: Provider training · Behavioral: Electronic reminders
Patient educational materials to address insufficient knowledge about harms of tobacco use and cessation.
Cessation counseling to address insufficient patient self-efficacy and motivation.
Nicotine patches to address nicotine withdrawal symptoms in patients.
Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.
Electronic reminders to address the lack of integration of AAA/AAC into practice.
7-day smoking abstinence
Carbon monoxide confirmed-abstinence from smoking in the last 7 days days prior to assessment
Time frame: 6 Months
Self-reported abstinence
Continuous abstinence, quit attempts, smoking reduction
Time frame: 1, 3, 6 months
Plan to share: No
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