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NCT Number: NCT05628389

Phone Enabled Implementation of Cessation Support

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut Medical Center

Beirut, Lebanon

Location status: Recruiting

Location contact

Maya Romani, MD

CONTACT

[email protected]

+9611350000 ext. 3014

Maya Romani, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational materials

Behavioral

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

Phone counseling

Behavioral

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

Nicotine Replacement Therapy

Drug

Nicotine patches to address nicotine withdrawal symptoms in patients.

Provider training

Behavioral

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

Electronic reminders

Behavioral

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

Primary outcomes

  1. 7-day smoking abstinence

    Time frame: 6 Months

    Carbon monoxide confirmed-abstinence from smoking in the last 7 days days prior to assessment

Other outcomes

  1. Self-reported abstinence

    Time frame: 1, 3, 6 months

    Continuous abstinence, quit attempts, smoking reduction

Study contacts

Contact information is provided by the study sponsor or research team.

Magda Montague, MPH

CONTACT

[email protected]

(352) 294-4997

Ramzi Salloum, PhD

CONTACT

[email protected]

(352) 294-4997

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: PHOENICS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 28, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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