Mobile Health Technology for Personalized Tobacco Cessation Support in Laos

What Was Tested

The trial (phase 2) is built around Therapeutic nicotine (patch, non-peptide).

To address this need, the investigators propose a project that adapts a theoretically and empirically based mobile health (mHealth) technology to help people quit smoking cigarettes in Lao PDR.

It had two arms (groups): Automated Treatment (experimental) and Standard Care (active comparator).

Consists of all SC components plus a fully automated smartphone-based treatment program that involves interactive and personalized proactive messages, images, or videos.

The registry classes the interventions as behavioral and drug.

More on the Plan

Inclusion criteria for all healthcare providers in the R21 Phase include 1) age ≥18 years; and 2) the ability to provide written informed consent to participate.

They can develop intervention messages if they wish or pinpoint the sources of treatment content that they use.

The investigators will use purposive sampling to select a diverse sample with regard to age, residence (urban vs. rural), disease type, and cessation phase, per the Phase-Based Model (PBM; see Conceptual Framework).

For all qualitative components in the R21 Phase, the investigators will use open-ended questions in all interviews/discussions.

Who Took Part

The registry lists 500 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged ≥18 years. Self-reported current combustible cigarette smokers (smoked at least 100 cigarettes in lifetime and currently smoke ≥1 cigarette/day). Willing to set a quit date within 2 weeks of study enrollment. Able to provide written informed consent to participate. Able to read Lao (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form).

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: history of a medical condition that precludes use of nrt; ineligibility to participate based on medical or psychiatric conditions diagnosed by a physician/clinician; enrollment in another cessation program or current use of other cessation medications.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: participant.

It started in 2022-04-27 with completion listed for 2026-08-31.

It ran at 2 sites in Laos (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Smoking status at 12 months post-enrollment (R33 Phase) (time frame: 12 months post enrollment). Smoking status at 3 months post-enrollment (Pilot RCT, R21 Phase) (time frame: 3 months post enrollment).

It also tracked 1 secondary outcome, for example Number of cigarettes smoked per day.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 500 people.

With 500 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.