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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553173
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
European Commission
Andaluz Health Service
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Health Behavior Lifestyle-related Condition Other: So-Lo-Mo Behavioral: Psychological advice Drug: Bupropion Pill Drug: Varenicline Pill Not Applicable

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:

  1. To monitor usual psycho-pharmacological therapies (bupropion, varenicline and behavioural therapy).
  2. To monitor healthy lifestyle and physical exercise habits.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized open-label parallel-group trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : October 24, 2016
Actual Primary Completion Date : October 24, 2018
Actual Study Completion Date : October 24, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control

Subjects undergoing usual psycho-pharmacological treatment for smoking cessation.

Prescribed treatments:

  • Bupropion pills + Psychological advice
  • Varenicline pills + Psychological advice
 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
Other Name: Behavioral

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.
Other Name: Bupropion

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.
Other Name: Varenicline
Experimental: Intervention

Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App.

Prescribed treatments:

  • Bupropion pills + Psychological advice + So-Lo-Mo
  • Varenicline pills + Psychological advice + So-Lo-Mo
 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).
Other Name: SoLoMo

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
Other Name: Behavioral

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.
Other Name: Bupropion

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.
Other Name: Varenicline


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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:

    • Low: Individuals who not meet criteria for categories 2 or 3 are considered 'low'
    • Moderate: 3 or more days of vigorous-intensity activity of at least 20 minutes per day OR 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum Total physical activity of at least 600 MET-minutes/week
    • High: vigorous-intensity activity on at least 3 days achieving a minimum Total physical activity of at least 1500 MET-minutes/week

  3. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553173


Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
European Commission
Andaluz Health Service
Investigators
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Principal Investigator: Francisco Ortega-Ruiz, MD, PhD Virgen del Rocío University Hiospital
  Study Documents (Full-Text)

Documents provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Study Protocol and Statistical Analysis Plan  [PDF] July 15, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT03553173    
Other Study ID Numbers: SFB-APP_EC-2016-01
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Smoking Cessation
App
Decision Support System
Additional relevant MeSH terms:
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Bupropion
Varenicline
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents