Smoking CessationPHOENICSNCT05628389
Phone Enabled Implementation of Cessation Support
A study testing Educational materials, Phone counseling and Nicotine Replacement Therapy in people with Smoking Cessation, run by University of Florida at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Educational materials, Phone counseling and Nicotine Replacement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteLebanon
- Study dates
- 6 Mar 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut
Maya Romani, MD, +9611350000 ext. 3014, mr39@aub.edu.lb
Maya Romani, MD
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Educational materials, Phone counseling, Nicotine Replacement Therapy, Provider training, Electronic reminders
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational materialsBehavioural
Patient educational materials to address insufficient knowledge about harms of tobacco use and cessation.
Phone counselingBehavioural
Cessation counseling to address insufficient patient self-efficacy and motivation.
Nicotine Replacement TherapyDrug
Nicotine patches to address nicotine withdrawal symptoms in patients.
Provider trainingBehavioural
Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.
Electronic remindersBehavioural
Electronic reminders to address the lack of integration of AAA/AAC into practice.
| Study group | Role | What they receive |
|---|---|---|
| Ask-Advice-Assist (AAA) | Other | All patients will be screened for tobacco use, and offer brief cessation advice and counseling. Receives: Behavioral: Educational materials; Behavioral: Provider training; Behavioral: Electronic reminders |
| Ask-Advise-Connect (AAC) | Experimental | Patients in will be connected to phone counseling and will receive six sessions of telephone counseling. Receives: Behavioral: Educational materials; Behavioral: Phone counseling; Behavioral: Provider training; Behavioral: Electronic reminders |
| Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT) | Experimental | In addition to AAC, patients will be offered NRT. Receives: Behavioral: Educational materials; Behavioral: Phone counseling; Drug: Nicotine Replacement Therapy; Behavioral: Provider training; Behavioral: Electronic reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day smoking abstinence
Carbon monoxide confirmed-abstinence from smoking in the last 7 days days prior to assessment
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start6 Mar 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ramzi Salloum, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628389
- Sponsor's protocol ID
- IRB202202537 -N
- Other IDs
- R01CA262319
- Acronym
- PHOENICS
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bteddini DS, El Ashkar C, Abla R, Montague M, El Kadi L, Kabakian-Khasholian T, Lee JH, Theis R, Khaywa J, Li D, Hamadeh RS, Ward K, Osman MH, Shelley DR, Romani M, Nakkash R, Salloum RG, LeLaurin JH. Adapting multicomponent tobacco use treatment strategies for implementation in the Lebanese primary healthcare system: a mixed-methods study. BMJ Open. 2026 Aug 31;16(8):e120118. doi: 10.1136/bmjopen-2026-120118.
PubMed 42674794Salloum 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.
PubMed 37365656
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phone Enabled Implementation of Cessation Support
- ClinicalTrials.gov ID
- NCT05628389
- Acronym / sponsor ID
- PHOENICS / IRB202202537 -N
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ask-Advice-Assist (AAA) | Other | Behavioral: Educational materials, Behavioral: Provider training, Behavioral: Electronic remindersAll patients will be screened for tobacco use, and offer brief cessation advice and counseling. |
| Ask-Advise-Connect (AAC) | Experimental | Behavioral: Educational materials, Behavioral: Phone counseling, Behavioral: Provider training, Behavioral: Electronic remindersPatients in will be connected to phone counseling and will receive six sessions of telephone counseling. |
| Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT) | Experimental | Behavioral: Educational materials, Behavioral: Phone counseling, Drug: Nicotine Replacement Therapy, Behavioral: Provider training, Behavioral: Electronic remindersIn addition to AAC, patients will be offered NRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational materialsPatient educational materials to address insufficient knowledge about harms of tobacco use and cessation. | Behavioural | Ask-Advice-Assist (AAA), Ask-Advise-Connect (AAC), Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT) |
| Phone counselingCessation counseling to address insufficient patient self-efficacy and motivation. | Behavioural | Ask-Advise-Connect (AAC), Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT) |
| Nicotine Replacement TherapyNicotine patches to address nicotine withdrawal symptoms in patients. | Drug | Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT) |
| Provider trainingProvider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients. | Behavioural | Ask-Advice-Assist (AAA), Ask-Advise-Connect (AAC), Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT) |
| Electronic remindersElectronic reminders to address the lack of integration of AAA/AAC into practice. | Behavioural | Ask-Advice-Assist (AAA), Ask-Advise-Connect (AAC), Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT) |
Primary outcome
7-day smoking abstinence
Time frame: 6 Months
Carbon monoxide confirmed-abstinence from smoking in the last 7 days days prior to assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 42674794Bteddini DS, El Ashkar C, Abla R, Montague M, El Kadi L, Kabakian-Khasholian T, Lee JH, Theis R, Khaywa J, Li D, Hamadeh RS, Ward K, Osman MH, Shelley DR, Romani M, Nakkash R, Salloum RG, LeLaurin JH. Adapting multicomponent tobacco use treatment strategies for implementation in the Lebanese primary healthcare system: a mixed-methods study. BMJ Open. 2026 Aug 31;16(8):e120118. doi: 10.1136/bmjopen-2026-120118.
- Derived from this study: PubMed 37365656Salloum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramzi Salloum, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational materials, Phone counseling and Nicotine Replacement Therapy in people with Smoking Cessation, run by University of Florida at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramzi Salloum, PhD ((352) 294-4997, rsalloum@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day smoking abstinence (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628389, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.