Phone Enabled Implementation of Cessation Support

NCT05628389 | Recruiting

• 2 other identifiers: IRB202202537 -NR01CA262319
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 7-day smoking abstinence

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

  6 Months

Other Outcomes (1)

• Self-reported abstinence

  1, 3, 6 months

Study Arms (3)

Ask-Advice-Assist (AAA)

OTHER

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

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.

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.

Behavioral: Educational materials; Behavioral: Phone counseling; Drug: Nicotine Replacement Therapy; Behavioral: Provider training; Behavioral: Electronic reminders

Interventions

Educational materials BEHAVIORAL

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

Ask-Advice-Assist (AAA); Ask-Advise-Connect (AAC); Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)

Phone counseling BEHAVIORAL

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

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

Nicotine Replacement Therapy DRUG

Nicotine patches to address nicotine withdrawal symptoms in patients.

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

Provider training BEHAVIORAL

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

Ask-Advice-Assist (AAA); Ask-Advise-Connect (AAC); Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)

Electronic reminders BEHAVIORAL

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

Ask-Advice-Assist (AAA); Ask-Advise-Connect (AAC); Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

Related Publications (1)

• 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.

  PMID: 37365656 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Ramzi Salloum, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramzi Salloum, PhD

CONTACT

(352) 294-4997; rsalloum@ufl.edu

Magda Montague, MPH

CONTACT

(352) 294-4997; mschmitzberger@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: March 6, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)