Smoking Cessation Treatment for Smokers With Obesity

NCT04332029 | Completed

• 1 other identifier: MCIU-19-RTI2018-101465-A-I00
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Tobacco Use Disorder

Keywords

Tobacco Use Disorder, Overweight, Obesity, Eating Disorders

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

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).

Behavioral: CBT + WGP

Interventions

CBT + WGP + CM BEHAVIORAL

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 + WGP + CM

CBT + WGP BEHAVIORAL

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.

CBT + WGP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oviedo: lead
• Ministerio de Ciencia e Innovación, Spain: collaborator
• State Research Agency, Spain: collaborator
• European Regional Development Fund: collaborator

Study Sites (1)

Clinical Unit of Addictive Behaviors. Faculty of Psychology. University of Oviedo.

Oviedo, Principality of Asturias, 33003, Spain

Location

Related Publications (1)

• 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.

  PMID: 35525238 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder; Overweight; Obesity; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: October 7, 2020
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)