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Smoking Cessation Treatment for Substance Use Dependents

NCT03551704 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-04-15

No results posted yet for this study

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. To analyze the feasibility (e.g., acceptability, compliance) of implementing the abovementioned protocol treatments to a community setting.
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. To assess the effects of smoking abstinence on other substance use.
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

Interventions

BEHAVIORAL

CBT + EFT

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 + CM

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.

Sponsors & Collaborators

  • University of Oviedo

    lead OTHER

Principal Investigators

  • Roberto Secades-Villa, PhD · University of Oviedo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2022-11-30
Completion
2022-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03551704 on ClinicalTrials.gov