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Phone Enabled Implementation of Cessation Support

Phone Enabled Implementation of Cessation Support

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05628389
Acronym
PHOENICS
Enrollment
1500
Registered
2022-11-28
Start date
2024-03-06
Completion date
2027-08-31
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALEducational materials

Patient educational materials to address insufficient knowledge about harms of tobacco use and cessation.

Cessation counseling to address insufficient patient self-efficacy and motivation.

DRUGNicotine Replacement Therapy

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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18+ * A current daily cigarette smoker and/or a regular waterpipe smoker (smokes at least 1-2 times/week). * Not pregnant * Reachable by phone * Interested in quitting * Lives in Greater Beirut Area

Exclusion criteria

* Patients who use other tobacco products including vape exclusively. * Any patient below 18 years old. * Cigarette smokers who do not smoke on daily basis. * Waterpipe smokers who smoke less than once/weekly

Design outcomes

Primary

MeasureTime frameDescription
7-day smoking abstinence6 MonthsCarbon monoxide confirmed-abstinence from smoking in the last 7 days days prior to assessment

Other

MeasureTime frameDescription
Self-reported abstinence1, 3, 6 monthsContinuous abstinence, quit attempts, smoking reduction

Countries

Lebanon

Contacts

Primary ContactRamzi Salloum, PhD
rsalloum@ufl.edu(352) 294-4997
Backup ContactMagda Montague, MPH
mschmitzberger@ufl.edu(352) 294-4997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026