Phone Enabled Implementation of Cessation Support

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,500 Participants
are divided into 3 treatment groups
Group A: Ask-Advice-Assist (AAA)Other 3 interventions
Group B: Ask-Advise-Connect (AAC)Experimental treatment 4 interventions
Group C: Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

7-day smoking abstinence

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

Time frame
6 Months

Secondary outcomes

Other outcomes

1

Self-reported abstinence

Continuous abstinence, quit attempts, smoking reduction

Time frame
1, 3, 6 months

Sponsors and contacts

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University of Florida

Lead sponsor

National Cancer Institute (NCI)

Collaborator