Tobacco Use DisorderNCT04332029
Smoking Cessation Treatment for Smokers With Obesity
A study testing CBT + WGP + CM and CBT + WGP in people with Tobacco Use Disorder, run by University of Oviedo at 1 site in Spain.
Trial summary
This study aims to developed an empirically validated psychological intervention protocol for smoking cessation among individuals with excess weight. Participants will be assigned to one of the two following conditions: 1) Cognitive-Behavioral Treatment (CBT) for smoking cessation + a Weight Gain Prevention module… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- CBT + WGP + CM and CBT + WGP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 7 Oct 2020to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being aged 18 or over.
- Having smoked 10 or more cigarettes/day within the last year.
- Meeting the diagnostic criteria for nicotine dependence according to the Diagnostic and Statistical Manual of Mental Disorders-5th ed. (American Psychiatric Association 2013).
- Having overweight or obesity (BMI above 25)
Who cannot join
- Not being able to attend the entire treatment.
- Being currently receiving other psychological/pharmacological treatment for smoking cessation or weight control
- Being diagnosed with a current severe psychiatric disorder, eating disorder other than Binge-Eating Disorder or Substance Use Disorder other than nicotine.
- Being pregnant, lactating or in the postpartum period
- Have any health condition that requires a specialized diet or affected eating
- Participants must not be taking a medication that impacts weight
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinical Unit of Addictive Behaviors. Faculty of Psychology. University of Oviedo.
Oviedo, Principality of Asturias, 33003
About this study
This study aims to developed an empirically validated psychological intervention protocol for smoking cessation among individuals with excess weight. Participants will be assigned to one of the two following conditions: 1) Cognitive-Behavioral Treatment (CBT) for smoking cessation + a Weight Gain Prevention module (WGP); 2) the same treatment alongside Contingency Management (CM) for smoking abstinence.
The main goals are: 1) to assess smoking abstinence rates in each condition at post-treatment and one, three, six and twelve month follow-ups, 2) to assess the effect of treatment conditions and abstinence on weight at each assessment point, 3) to analyze the potential moderating effect of individual variables: socio-demographic characteristics, severity of nicotine dependence and demand, disordered eating, impulsivity and emotional regulation.
Read the detailed description
Smoking rates are quite high among overweight or obese population. In this regard, smokers with excess weight use to report fear to quit due to post-cessation weight gain concerns, the presence of disordered eating (binge eating and emotional eating) before or during the quitting process, weight increase, relapse risk, risk of metabolic syndrome, obesity or diabetes and cardiovascular risk factors. Despite previous efforts, research is still required to assess the course of eating-related problems in smoking cessation, the impact of smoking on the onset and development of psychological and medical issues and, particularly, it is necessary to perform studies to assess the efficacy of psychological interventions for smoking cessation among individuals with excess weight. Prior evidence showed that Contingency Management (CM) techniques are adequate to reduce tobacco use and perform better than other interventions and control conditions. Nevertheless, there is a lack of research exploring the effectiveness of CM for overweight or obese smokers.The primary aim of this clinical trial is to yield data on the effectiveness of a psychological intervention for smoking cessation among individuals with excess weight. Participants will be assigned to one of the two following conditions: 1) Cognitive-Behavioral Treatment (CBT) for gradual smoking cessation + a Weight Gain Prevention module (WGP) for weight stability; 2) the same treatment alongside Contingency Management (CM) for smoking abstinence. In view to assure adequate power for achieving statistical significance, investigators carried out a priori power analysis by using the G*Power 3.1. An estimated sample size of 120 participants would detect a medium effect size (Cohen's d = 0.3, with power (1-β) set at 0.97 and α = 05).The primary analyses derived from this clinical trial will be conducted using Statistical Package for the Social Science (SPSS) version 24 for Windows. A set of descriptive and frequency analyses will be carried out with regard to participants' characteristics. Comparisons between treatment groups in both baseline characteristics and treatment outcomes will be conducted using a set of chi-square tests for categorical variables and t-tests (two-tailed) for continuous variables.
- Conditions
- Tobacco Use Disorder
- Being tested
- CBT + WGP + CM, CBT + WGP
- Keywords
- Tobacco Use Disorder, Overweight, Obesity, Eating Disorders
- Medical subject headings
- Tobacco Use Disorder, Overweight, Obesity, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT + WGP + CMBehavioural
The intervention will be implemented in 8-week group-based sessions and includes: 1) A Cognitive Behavioral Treatment (CBT) for smoking cessation with quit date occurring at sixth session. Patients will be asked to reduce their nicotine intake gradually (i.e., 20% each week); 2) A Weight Gain Prevention module (WGP) which will consist on providing CBT and Dialectical-Behavioral Therapy (DBT) techniques targeting weight stability and associated disordered eating, and 3) a Contingency Management procedure reinforcing smoking abstinence. This component will consist on providing vouchers to reinforce abstinence contingent on biochemical verification. The schedule will incorporate an increasing magnitude of reinforcement.
CBT + WGPBehavioural
The intervention will be implemented in 8-week group-based sessions and will include only the first two components of the experimental intervention: 1) A Cognitive Behavioral Treatment (CBT) for smoking cessation with quit date occurring at sixth session. Patients will be asked to reduce their nicotine intake gradually (i.e., 20% each week); 2) A Weight Gain Prevention module (WGP) which will consist on providing CBT and Dialectical-Behavioral Therapy (DBT) techniques targeting weight stability and associated disordered eating.
| Study group | Role | What they receive |
|---|---|---|
| CBT + WGP + CM | Experimental | The experimental intervention includes three components: 1) Cognitive Behavioral Treatment (CBT) for gradual smoking cessation; 2) Weight Gain Prevention module (WGP) and; 3) Contingency Management (CM) procedure reinforcing tobacco abstinence. Receives: Behavioral: CBT + WGP + CM |
| CBT + WGP | Active comparator | The active comparator will include only the first two components of the experimental intervention: 1) Cognitive Behavioral Treatment (CBT) for gradual smoking cessation and 2) Weight Gain Prevention module (WGP). Receives: Behavioral: CBT + WGP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Smoking abstinence
Abstinence is defined as achieving a period of at least 24 hours of abstinence (end-of-treatment) or not smoking since the prior last 7 days. Abstinence is assessed by means of carbon monoxide (CO) and cotinine samples.
Measured: Through Study Completion: End-of-treatment (8-week), 1, 3, 6 and 12 month follow-up
Changes in Continuous smoking abstinence
Abstinence is defined as no smoking (not even a puff) since the participant´s quit day. Abstinence is assessed by means of carbon monoxide (CO) and cotinine samples
Measured: Through Study Completion: End-of-treatment (8-week), 1, 3, 6 and 12 month follow-up.
Weight Change
At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes.
Measured: Through Study Completion: End-of-treatment (8-week), 1, 3, 6 and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start7 Oct 2020
- Primary completion31 Dec 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to each of the two treatment conditions in accordance with a computer-generated randomization list. The treatment conditions will be actively running in parallel.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain, State Research Agency, Spain, European Regional Development Fund
- Responsible party
- Principal investigator, Gloria García Fernández, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332029
- Sponsor's protocol ID
- MCIU-19-RTI2018-101465-A-I00
- Status last verified
- Nov 2023
- First submitted
- 30 Mar 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Fernandez G, Krotter A, Garcia-Perez A, Aonso-Diego G, Secades-Villa R. Pilot randomized trial of cognitive-behavioral treatment plus contingency management for quitting smoking and weight gain prevention among smokers with overweight or obesity. Drug Alcohol Depend. 2022 Jul 1;236:109477. doi: 10.1016/j.drugalcdep.2022.109477. Epub 2022 Apr 29.
PubMed 35525238
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Treatment for Smokers With Obesity
- ClinicalTrials.gov ID
- NCT04332029
- Acronym / sponsor ID
- MCIU-19-RTI2018-101465-A-I00
- Conditions
- Tobacco Use Disorder
- Keywords
- Tobacco Use Disorder, Overweight, Obesity, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain, State Research Agency, Spain, European Regional Development Fund
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to developed an empirically validated psychological intervention protocol for smoking cessation among individuals with excess weight. Participants will be assigned to one of the two following conditions: 1) Cognitive-Behavioral Treatment (CBT) for smoking cessation + a Weight Gain Prevention module (WGP); 2) the same treatment alongside Contingency Management (CM) for smoking abstinence.
The main goals are: 1) to assess smoking abstinence rates in each condition at post-treatment and one, three, six and twelve month follow-ups, 2) to assess the effect of treatment conditions and abstinence on weight at each assessment point, 3) to analyze the potential moderating effect of individual variables: socio-demographic characteristics, severity of nicotine dependence and demand, disordered eating, impulsivity and emotional regulation.
Detailed description
Smoking rates are quite high among overweight or obese population. In this regard, smokers with excess weight use to report fear to quit due to post-cessation weight gain concerns, the presence of disordered eating (binge eating and emotional eating) before or during the quitting process, weight increase, relapse risk, risk of metabolic syndrome, obesity or diabetes and cardiovascular risk factors. Despite previous efforts, research is still required to assess the course of eating-related problems in smoking cessation, the impact of smoking on the onset and development of psychological and medical issues and, particularly, it is necessary to perform studies to assess the efficacy of psychological interventions for smoking cessation among individuals with excess weight. Prior evidence showed that Contingency Management (CM) techniques are adequate to reduce tobacco use and perform better than other interventions and control conditions. Nevertheless, there is a lack of research exploring the effectiveness of CM for overweight or obese smokers.The primary aim of this clinical trial is to yield data on the effectiveness of a psychological intervention for smoking cessation among individuals with excess weight. Participants will be assigned to one of the two following conditions: 1) Cognitive-Behavioral Treatment (CBT) for gradual smoking cessation + a Weight Gain Prevention module (WGP) for weight stability; 2) the same treatment alongside Contingency Management (CM) for smoking abstinence. In view to assure adequate power for achieving statistical significance, investigators carried out a priori power analysis by using the G*Power 3.1. An estimated sample size of 120 participants would detect a medium effect size (Cohen's d = 0.3, with power (1-β) set at 0.97 and α = 05).The primary analyses derived from this clinical trial will be conducted using Statistical Package for the Social Science (SPSS) version 24 for Windows. A set of descriptive and frequency analyses will be carried out with regard to participants' characteristics. Comparisons between treatment groups in both baseline characteristics and treatment outcomes will be conducted using a set of chi-square tests for categorical variables and t-tests (two-tailed) for continuous variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to each of the two treatment conditions in accordance with a computer-generated randomization list. The treatment conditions will be actively running in parallel.
| Arm | Type | Receives |
|---|---|---|
| CBT + WGP + CM | Experimental | Behavioral: CBT + WGP + CMThe experimental intervention includes three components: 1) Cognitive Behavioral Treatment (CBT) for gradual smoking cessation; 2) Weight Gain Prevention module (WGP) and; 3) Contingency Management (CM) procedure reinforcing tobacco abstinence. |
| CBT + WGP | Active comparator | Behavioral: CBT + WGPThe active comparator will include only the first two components of the experimental intervention: 1) Cognitive Behavioral Treatment (CBT) for gradual smoking cessation and 2) Weight Gain Prevention module (WGP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being aged 18 or over.
- Having smoked 10 or more cigarettes/day within the last year.
- Meeting the diagnostic criteria for nicotine dependence according to the Diagnostic and Statistical Manual of Mental Disorders-5th ed. (American Psychiatric Association 2013).
- Having overweight or obesity (BMI above 25)
Key exclusion criteria (6 listed)
- Not being able to attend the entire treatment.
- Being currently receiving other psychological/pharmacological treatment for smoking cessation or weight control
- Being diagnosed with a current severe psychiatric disorder, eating disorder other than Binge-Eating Disorder or Substance Use Disorder other than nicotine.
- Being pregnant, lactating or in the postpartum period
- Have any health condition that requires a specialized diet or affected eating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT + WGP + CMThe intervention will be implemented in 8-week group-based sessions and includes: 1) A Cognitive Behavioral Treatment (CBT) for smoking cessation with quit date occurring at sixth session. Patients will be asked to reduce their nicotine intake gradually (i.e., 20% each week); 2) A Weight Gain Prevention module (WGP) which will consist on providing CBT and Dialectical-Behavioral Therapy (DBT) techniques targeting weight stability and associated disordered eating, and 3) a Contingency Management procedure reinforcing smoking abstinence. This component will consist on providing vouchers to reinforce abstinence contingent on biochemical verification. The schedule will incorporate an increasing magnitude of reinforcement. | Behavioural | CBT + WGP + CM |
| CBT + WGPThe intervention will be implemented in 8-week group-based sessions and will include only the first two components of the experimental intervention: 1) A Cognitive Behavioral Treatment (CBT) for smoking cessation with quit date occurring at sixth session. Patients will be asked to reduce their nicotine intake gradually (i.e., 20% each week); 2) A Weight Gain Prevention module (WGP) which will consist on providing CBT and Dialectical-Behavioral Therapy (DBT) techniques targeting weight stability and associated disordered eating. | Behavioural | CBT + WGP |
Primary outcome
Changes in Smoking abstinence
Time frame: Through Study Completion: End-of-treatment (8-week), 1, 3, 6 and 12 month follow-up
Abstinence is defined as achieving a period of at least 24 hours of abstinence (end-of-treatment) or not smoking since the prior last 7 days. Abstinence is assessed by means of carbon monoxide (CO) and cotinine samples.
Changes in Continuous smoking abstinence
Time frame: Through Study Completion: End-of-treatment (8-week), 1, 3, 6 and 12 month follow-up.
Abstinence is defined as no smoking (not even a puff) since the participant´s quit day. Abstinence is assessed by means of carbon monoxide (CO) and cotinine samples
Weight Change
Time frame: Through Study Completion: End-of-treatment (8-week), 1, 3, 6 and 12 month follow-up
At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Results publication: PubMed 35525238Garcia-Fernandez G, Krotter A, Garcia-Perez A, Aonso-Diego G, Secades-Villa R. Pilot randomized trial of cognitive-behavioral treatment plus contingency management for quitting smoking and weight gain prevention among smokers with overweight or obesity. Drug Alcohol Depend. 2022 Jul 1;236:109477. doi: 10.1016/j.drugalcdep.2022.109477. Epub 2022 Apr 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT + WGP + CM and CBT + WGP in people with Tobacco Use Disorder, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Smoking abstinence (time frame: Through Study Completion: End-of-treatment (8-week), 1, 3, 6 and 12 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.