Phone Enabled Implementation of Cessation Support

NCT ID: NCT05628389

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-06

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ask-Advice-Assist (AAA)

All patients will be screened for tobacco use, and offer brief cessation advice and counseling.

Group Type OTHER

Educational materials

Intervention Type BEHAVIORAL

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

Provider training

Intervention Type BEHAVIORAL

Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.

Electronic reminders

Intervention Type BEHAVIORAL

Electronic reminders to address the lack of integration of AAA/AAC into practice.

Ask-Advise-Connect (AAC)

Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.

Group Type EXPERIMENTAL

Educational materials

Intervention Type BEHAVIORAL

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

Phone counseling

Intervention Type BEHAVIORAL

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

Provider training

Intervention Type BEHAVIORAL

Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.

Electronic reminders

Intervention Type BEHAVIORAL

Electronic reminders to address the lack of integration of AAA/AAC into practice.

Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)

In addition to AAC, patients will be offered NRT.

Group Type EXPERIMENTAL

Educational materials

Intervention Type BEHAVIORAL

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

Phone counseling

Intervention Type BEHAVIORAL

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

Nicotine Replacement Therapy

Intervention Type DRUG

Nicotine patches to address nicotine withdrawal symptoms in patients.

Provider training

Intervention Type BEHAVIORAL

Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.

Electronic reminders

Intervention Type BEHAVIORAL

Electronic reminders to address the lack of integration of AAA/AAC into practice.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Educational materials

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

Intervention Type BEHAVIORAL

Phone counseling

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

Intervention Type BEHAVIORAL

Nicotine Replacement Therapy

Nicotine patches to address nicotine withdrawal symptoms in patients.

Intervention Type DRUG

Provider training

Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.

Intervention Type BEHAVIORAL

Electronic reminders

Electronic reminders to address the lack of integration of AAA/AAC into practice.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ramzi Salloum, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

American University of Beirut Medical Center

Beirut, , Lebanon

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Lebanon

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ramzi Salloum, PhD

Role: CONTACT

(352) 294-4997

Magda Montague, MPH

Role: CONTACT

(352) 294-4997

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Maya Romani, MD

Role: primary

+9611350000 ext. 3014

References

Explore related publications, articles, or registry entries linked to this study.

Salloum RG, Romani M, Bteddini DS, El-Jardali F, Lee JH, Theis R, LeLaurin JH, Hamadeh R, Osman M, Abla R, Khaywa J, Ward KD, Shelley D, Nakkash R. An effectiveness-implementation hybrid trial of phone-based tobacco cessation interventions in the Lebanese primary healthcare system: protocol for project PHOENICS. Implement Sci Commun. 2023 Jun 26;4(1):72. doi: 10.1186/s43058-023-00456-w.

Reference Type DERIVED
PMID: 37365656 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01CA262319

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202202537 -N

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mobile Contingency Management for Smoking Cessation
NCT04881630 ACTIVE_NOT_RECRUITING NA
Improving Quitline Support Study
NCT03538938 COMPLETED PHASE4