So-Lo-Mo Intervention Applied to the Smoking Cessation Process

Summary

This is a randomized open-label parallel-group trial. 240 subjects will be recruited during 8 months and a 12 months follow-up will be carried out for each one of them. The sample will split in two groups: control group (n=120) who will receive usual psycho-pharmacological therapy and the intervention group (n=120) who will receive usual therapy plus So-Lo-Mo app.

Conditions

• Smoking Cessation
• Health Behavior
• Lifestyle-related Condition

Interventions

OTHER

So-Lo-Mo

So-Lo-Mo is an innovative intervention based on mobile technologies and its capacity to trigger behavioral changes. In this sense, the App is a complement to pharmacological therapies to quit smoking providing personalised motivational messages, physical activity monitoring, lifestyle advices and distractions (mini-games) to help pass the cravings. The main objective of this App is to improve patient's adherence to the smoking cessation process making use of behavioral techniques in the form of motivational messages and/or Short Message Service (SMS).

BEHAVIORAL

Psychological advice

Provision of information about smoking and smoking cessation process, as well as supporting behavioral changes through the provision of new skills and strategies. The most used methods are the motivational interview and the cognitive-behavioral therapy

DRUG

Bupropion Pill

Formulated as a 150 mg long discharge pill, usually being prescribed a daily dose of 300 mg, except for week one which would be prescribed 150 mg per day. The usual length of the treatment ranges from 7 to 9 weeks. However, 12 weeks treatments could be prescribed for severe cases of smokers.

DRUG

Varenicline Pill

Formulated as 0,5 mg and 1 mg pills, and the dose should be progressively incremented during the first days in order to facilitate tolerance. The recommended length of the treatment is 12 weeks, although longer treatments could be necessary for severe smokers.

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• Andaluz Health Service

  collaborator OTHER_GOV

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

  lead OTHER

Principal Investigators

• Francisco Ortega-Ruiz, MD, PhD · Virgen del Rocío University Hiospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-24

Primary Completion

2018-10-24

Completion

2018-10-24