Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

Tobacco Use Disorder Clinical Trial

Official title:

Increasing the Smoking Cessation Success Rate by Enhancing Improvement of Self-control Through Sleep-amplified Memory Consolidation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05726045
• Other study ID #: TRR265 C01-P2
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Central Institute of Mental Health, Mannheim
• Contact: Sabine Vollstädt-Klein, Prof. Dr.
• Phone: +49-621/1703
• Email: s.vollstaedt-klein[@]zi-mannheim.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Standard smoking cessation program (SCP)
Each subject will receive a standard SCP as group treatment once a week (1h) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra & Buchkremer, 2004), and will be carried out by a qualified therapist.
• Cognitive remediation treatment (CRT)
The cognitive remediation treatment (CRT) employs a chess-based battery of tasks (delivered through an app-based online tool), two times per week over six weeks (60min duration per session).
• High-intensity interval training (HIIT evening)
The high-intensity interval training will be delivered through an app environment with several choices of exercise, two times per week over six weeks. The training will include a 5-minutes warm-up and cool down phase. In between, participants will perform four 4-minutes blocks of exercise at high intensity, interspersed with three 3-minute blocks of low intensity (total of 35 minutes exercise).

Locations

Country	Name	City	State
Germany	Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit	Mannheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

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