- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03553173
So-Lo-Mo Intervention Applied to the Smoking Cessation Process (So-Lo-Mo)
A Randomized Open-label Parallel-group Trial is to Analyze the Efficacy and the Efficiency of the Social-Local-Mobile (So-Lo-Mo) Intervention Applied to the Smoking Cessation Process.
Study Overview
Status
Intervention / Treatment
Detailed Description
The main objective of this study is to analyze the efficacy and efficiency of the So-Lo-Mo intervention applied to the smoking cessation process compared to usual care.
Secondary objectives are:
- To monitor usual psycho-pharmacological therapies (bupropion, varenicline and behavioural therapy).
- To monitor healthy lifestyle and physical exercise habits.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Smoking population attending to the Smoking Cessation Unit of "Virgen del Rocío" University Hospital.
- Subjects >18 years old who want to give up smoking.
- Android-based smart phone availability.
- Ability to interact with the smart phone.
- To sign an Informed Consent Form.
Exclusion Criteria:
- Subjects had some previous adverse effects related to the pharmacological treatment included in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Subjects undergoing usual psycho-pharmacological treatment for smoking cessation. Prescribed treatments:
|
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
Other Names:
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.
Other Names:
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.
Other Names:
|
Experimental: Intervention
Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App. Prescribed treatments:
|
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
Other Names:
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.
Other Names:
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.
Other Names:
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: Smoking abstinence rate
Time Frame: 1 year
|
Smoking abstinence rate at 1 year measured by means of exhaled Carbon Monoxide (CO) and urinary cotinine tests.
Subjects with cotinine concentrations >200 ng/ml or CO >6 ppm will be considered as smokers.
|
1 year
|
Efficiency: Incremental Cost-Effectiveness Ratio
Time Frame: 1 year
|
Expressed in terms of Incremental Cost-Effectiveness Ratio (ICER), calculated by dividing the difference in total costs between the intervention group and the control group by the difference in Quality-Adjusted Life Year (QALY) between both groups.
Costs associated to control and intervention groups will include healthcare resources utilization measured in terms of specialist consultations related to the smoking cessation process.
Costs of pharmacological treatment and time employed by healthcare professionals during the design phase will also be taken into account.
Benefit for patients will be expressed in terms of QALY.
EuroQol-5D-5L questionnaire will be used to estimate QALY.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Related Adverse Events [Safety]
Time Frame: 1 year
|
To monitor usual pharmacological therapies (bupropion and varenicline) in order to gather the incidence of related adverse events reported. Safety will be measured as the number of adverse events related to pharmacological therapies. The following adverse events have been identified related to each pharmacological therapy: Varenicline: Nausea, vomit, headache, insomnia, abnormal dreams, constipation and flatulence. Bupropion: insomnia, headache, dryness in the mouth, alteration of taste, skin reactions, convulsions, cardiovascular side effects and severe skin reactions. |
1 year
|
International Physical Activity Questionnaire (IPAQ27) score [Physical activity]
Time Frame: From baseline (first evaluation in the study) to 1 year after
|
Physical activity will be measured in terms of the International Physical Activity Questionnaire (IPAQ27) score calculation at baseline (first evaluation in the study) and at the end of the intervention (after 1 year of follow-up). The result is expressed as metabolic equivalent (MET)-minutes per week. Interpretation:
|
From baseline (first evaluation in the study) to 1 year after
|
Body Mass Index (BMI) in kg/m^2 [Healthy lifestyle]
Time Frame: From baseline (first evaluation in the study) to 1 year after
|
Healthy lifestyle will be measured in terms of the subject's BMI (weight in kg / height in m^2) at baseline (first evaluation in the study) and at the end of the intervention (after 1 year of follow-up).
|
From baseline (first evaluation in the study) to 1 year after
|
Collaborators and Investigators
Investigators
- Principal Investigator: Francisco Ortega-Ruiz, MD, PhD, Virgen del Rocío University Hiospital
Publications and helpful links
General Publications
- Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Carrasco-Hernandez L, Jodar-Sanchez F, Nunez-Benjumea F, Moreno Conde J, Mesa Gonzalez M, Civit-Balcells A, Hors-Fraile S, Parra-Calderon CL, Bamidis PD, Ortega-Ruiz F. A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 27;8(4):e17530. doi: 10.2196/17530.
- Jodar-Sanchez F, Carrasco Hernandez L, Nunez-Benjumea FJ, Mesa Gonzalez MA, Moreno Conde J, Parra Calderon CL, Fernandez-Luque L, Hors-Fraile S, Civit A, Bamidis P, Ortega-Ruiz F. Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Dec 6;7(12):e12464. doi: 10.2196/12464.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Nicotinic Agonists
- Cholinergic Agonists
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Bupropion
- Varenicline
Other Study ID Numbers
- SFB-APP_EC-2016-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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