Smoking Cessation Treatment for Smokers With Obesity

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Behavioral: CBT + WGP + CM; Behavioral: CBT + WGP

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Asturias
    • Oviedo, Asturias, Spain, 33003
      • Clinical Unit of Addictive Behaviors. Faculty of Psychology. University of Oviedo.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT + WGP + CM; 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.	Behavioral: CBT + WGP + CM; 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.
Active Comparator: CBT + WGP; 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).	Behavioral: CBT + WGP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	Through Study Completion: End-of-treatment (8-week), 1, 3, 6 and 12 month follow-up

Collaborators and Investigators

• Sponsor: University of Oviedo
• Collaborators: European Regional Development Fund; Ministerio de Ciencia e Innovación, Spain; Spanish State Research Agency

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Tobacco Use Disorder, Overweight, Obesity, Eating Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Tobacco Use Disorder
• Other Study ID Numbers: MCIU-19-RTI2018-101465-A-I00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No