Smoking Cessation Treatment for Substance Use Dependents

NCT03551704 | Completed

• 1 other identifier: MSSSI-2017-2017I036
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The present research project aims to develop an innovative and empirically validated intervention protocol for smoking cessation among patients with substance use disorders (SUDs). For this purpose, two smoking cessation treatments tailored for SUDs will be assessed. Participants will be assigned to one of the following treatment conditions: 1) Cognitive-behavioral treatment for smoking cessation (CBT) + Episodic Future Thinking (EFT); 2) The same treatment alongside Contingency Management (CM) for shaping abstinence. The main goals are:

1. 1.To analyze the feasibility (e.g., acceptability, compliance) of implementing the abovementioned protocol treatments to a community setting.
2. 2.To assess abstinence rates in each treatment condition at short and long-term follow-ups: post-treatment, one, two, three, six and twelve months after post-treatment.
3. 3.To assess the effects of smoking abstinence on other substance use.
4. 4.To analyze the moderating effect of individual variables over treatment outcomes: sociodemographic characteristics, drug demand, severity of nicotine dependence and SUD, severity of depressive symptomatology and impulsivity.

Conditions

Tobacco Use Disorder

Keywords

Smoking; Substance addiction; Cocaine; Alcohol; Behavioral treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  End-of-treatment (8-week), 1, 2, 3, 6 and 12 month follow-up

• Changes in Continuous 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.

  1, 2, 3, 6 and 12 month follow-up since the treatment completion

Secondary Outcomes (6)

• Changes in Other Substance Abstinence

  End-of-treatment (8-week), 1, 2, 3, 6 and 12 month follow-up since the treatment completion

• Changes in Drug demand

  Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion

• Changes in Health-Related Quality of Life

  Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion

• Changes in Depression

  Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion

• Changes in Impulsivity

  Intake (baseline), end-of-treatment (8-week),1,2,3,6 and 12 months follow-up since treatment completion

Study Arms (2)

CBT + EFT

ACTIVE COMPARATOR

The CBT treatment will be implemented in 8-week group-based sessions (maximum 4 patients). Sessions will be carried out once a week over an 8-week period, with quit date occurring at fifth session. Patients will be asked to gradually reduce their nicotine intake (i.e., 25% each week). CBT components include: psychoeducation, self-monitoring, physiological feedback, training in stimulus control and strategies for controlling negative discomfort, and relapse prevention strategies. As part of the EFT, participants will be asked to select future smoking-related events that would occur within the following time periods: 2 weeks, 1, and 6 months. They will be instructed to generate personal audio recordings that will be used to help them think about future decision-making choices.

Behavioral: CBT + EFT

CBT + EFT + CM

EXPERIMENTAL

This intervention includes the abovementioned treatment components and a CM procedure reinforcing abstinence. This arm will consist on delivering CBT and EFT and providing patients incentives to promote and reinforce abstinence contingent on biochemical verification. The schedule will incorporate an increasing magnitude of reinforcement.

Behavioral: CBT + EFT + CM

Interventions

CBT + EFT BEHAVIORAL

The CBT treatment will be implemented in 8-week group-based sessions (maximum 4 patients). Sessions will be carried out once a week over an 8-week period, with quit date occurring at fifth session. Patients will be asked to gradually reduce their nicotine intake (i.e., 25% each week). CBT components include: psychoeducation, self-monitoring, physiological feedback, training in stimulus control and strategies for controlling negative discomfort, and relapse prevention strategies. As part of the EFT, participants will be asked to select future smoking-related events that would occur within the following time periods: 2 weeks, 1, and 6 months. They will be instructed to generate personal audio recordings that will be used to help them think about future decision-making choices.

CBT + EFT

CBT + EFT + CM BEHAVIORAL

This intervention includes the abovementioned treatment components and a CM procedure reinforcing abstinence. This arm will consist on delivering CBT and EFT and providing patients incentives to promote and reinforce abstinence contingent on abstinence. The schedule will incorporate an increasing magnitude of reinforcement.

CBT + EFT + CM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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).
• Undergoing outpatient cocaine or alcohol treatment.

You may not qualify if:

• Not being able to attend the entire treatment.
• Being currently receiving other psychological/pharmacological treatment for smoking cessation.
• Being diagnosed with a current severe psychiatric disorder (i.e., schizophrenia,bipolar disorder).

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

Clinical Unit of Addictive Behaviors

Oviedo, Principality of Asturias, 33003, Spain

Location

Related Publications (5)

• Secades-Villa R, Gonzalez-Roz A, Garcia-Perez A, Becona E. Psychological, pharmacological, and combined smoking cessation interventions for smokers with current depression: A systematic review and meta-analysis. PLoS One. 2017 Dec 5;12(12):e0188849. doi: 10.1371/journal.pone.0188849. eCollection 2017.

  PMID: 29206852 BACKGROUND

• McKelvey K, Thrul J, Ramo D. Impact of quitting smoking and smoking cessation treatment on substance use outcomes: An updated and narrative review. Addict Behav. 2017 Feb;65:161-170. doi: 10.1016/j.addbeh.2016.10.012. Epub 2016 Oct 27.

  PMID: 27816663 RESULT

• Secades-Villa R, Vallejo-Seco G, Garcia-Rodriguez O, Lopez-Nunez C, Weidberg S, Gonzalez-Roz A. Contingency management for cigarette smokers with depressive symptoms. Exp Clin Psychopharmacol. 2015 Oct;23(5):351-60. doi: 10.1037/pha0000044. Epub 2015 Aug 17.

  PMID: 26280589 RESULT

• Weidberg S, Vallejo-Seco G, Gonzalez-Roz A, Garcia-Perez A, Secades-Villa R. In-treatment cigarette demand among treatment-seeking smokers with depressive symptoms. Addict Behav. 2018 Jul;82:35-43. doi: 10.1016/j.addbeh.2018.02.022. Epub 2018 Feb 16.

  PMID: 29482033 RESULT

• Cooney JL, Cooper S, Grant C, Sevarino K, Krishnan-Sarin S, Gutierrez IA, Cooney NL. A Randomized Trial of Contingency Management for Smoking Cessation During Intensive Outpatient Alcohol Treatment. J Subst Abuse Treat. 2017 Jan;72:89-96. doi: 10.1016/j.jsat.2016.07.002. Epub 2016 Jul 15.

  PMID: 27542442 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Roberto Secades-Villa, PhD

  University of Oviedo

  PRINCIPAL INVESTIGATOR

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: Professor, 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: May 9, 2018
• First Posted: June 11, 2018
• Study Start: January 15, 2018
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)