Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

Not Applicable

Recruiting

• Conditions: Tobacco Use Disorder
• Interventions: Behavioral: Standard smoking cessation program (SCP); Behavioral: Cognitive remediation treatment (CRT); Behavioral: High-intensity interval training (HIIT evening)

• Registration Number: NCT05726045
• Lead Sponsor: Central Institute of Mental Health, Mannheim

Brief Summary

The goal of this subproject is to examine the hypothesized improvement of treatment with chess-based training and sleep enhancement, both together and on their own, in smokers.

Participants will undergo fMRI measurements, sleep monitoring. They will then be assigned to one of the four experimental groups, including high-intensity interval training with or without chess-based training.

Detailed Description

This subproject aims to improve treatment outcome in patients with tobacco use disorder (TUD) by enhancing cognitive control. Evidence from the first funding period (1st FP) indicates that enhancing cognitive control using cognitive remediation training (CRT, in our case chess-based) can improve outcomes of a standard smoking cessation program. The current project will harness three means to build on this success of enhancing cognitive control by: 1. using our tried-and-tested chess-based training, 2. improving sleep using high-intensity interval training (HIIT), 3. increasing sleep-dependent consolidation of the chess-based training (see Figure 1). We hypothesize that chess-based training and sleep enhance treatment outcome, both together and on their own. To test our hypotheses, we will combine smoking cessation treatment with the aforementioned approaches as app-based add-ons (chess-based training and HIIT). This will not only allow us to apply the training in a cost-efficient way out-side the lab, it may also increase patients' compliance.

Study Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Study Start: 2024-04-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• severe tobacco use disorder (TUD) according to DSM-5
• sufficient ability to communicate with investigators and answer questions in both written and verbal format
• ability to provide fully informed consent and to use self-rating scales
• right-handedness
• HIIT can be performed without the risk of side effect (medical sports check)

Exclusion Criteria

• severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months
• history of brain injury
• severe physical diseases
• common exclusion criteria for MRI (e.g. metal, claustrophobia)
• positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
• psychotropic medication within the last 14 days
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
HIIT evening	Standard smoking cessation program (SCP)	High-intensity interval training (HIIT) in the evening
HIIT morning	Standard smoking cessation program (SCP)	High-intensity interval training (HIIT) in the morning
HIIT morning + CRT	Standard smoking cessation program (SCP)	High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT)
HIIT morning + CRT	Cognitive remediation treatment (CRT)	High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT)
HIIT evening + CRT	Standard smoking cessation program (SCP)	High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)
HIIT evening	High-intensity interval training (HIIT evening)	High-intensity interval training (HIIT) in the evening
HIIT evening + CRT	Cognitive remediation treatment (CRT)	High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)
HIIT evening + CRT	High-intensity interval training (HIIT evening)	High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)

Primary Outcome Measures

Name	Time	Method
Percentage of abstinent days	timepoint 3: follow-up 3 months after end of SCP	Percentage of abstinent days in the 3 months after treatment
Change in neural measures of response inhibition	2 time points: before and after 6 weeks SCP	SST fMRI task (Gan et al., 2014)
Change in neural functional connectivity in the salience network	2 time points: before and after 6 weeks SCP	resting state connectivity to seed region right anterior insula
Time until first severe relapse	timepoint 3: follow-up 3 months after end of SCP	days until the first severe smoking relapse after treatment
Change in neural measures of working memory	2 time points: before and after 6 weeks SCP	Nback fMRI task (Charlet et al., 2014)
Change in smoking urges	2 time points: before and after 6 weeks SCP	questionnaire of smoking urges (QSU, Müller et al. 2001)

Trial Locations

Locations (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit; 🇩🇪 Mannheim, Baden-Württemberg, Germany