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NCT Number: NCT05726045

Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

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.

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Key information

Conditions

Tobacco Use Disorder Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Disease Attributes Health Behavior Impulsive Behavior Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Smoking Cessation Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, 68159, Germany

Location status: Recruiting

Location contact

Sabine Vollstädt-Klein, Prof. Dr.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard smoking cessation program (SCP)

Behavioral

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)

Behavioral

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)

Behavioral

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).

Primary outcomes

  1. Time until first severe relapse

    Time frame: timepoint 3: follow-up 3 months after end of SCP

    days until the first severe smoking relapse after treatment

  2. Percentage of abstinent days

    Time frame: timepoint 3: follow-up 3 months after end of SCP

    Percentage of abstinent days in the 3 months after treatment

  3. Change in smoking urges

    Time frame: 2 time points: before and after 6 weeks SCP

    questionnaire of smoking urges (QSU, Müller et al. 2001)

  4. Change in neural measures of response inhibition

    Time frame: 2 time points: before and after 6 weeks SCP

    SST fMRI task (Gan et al., 2014)

  5. Change in neural measures of working memory

    Time frame: 2 time points: before and after 6 weeks SCP

    Nback fMRI task (Charlet et al., 2014)

  6. Change in neural functional connectivity in the salience network

    Time frame: 2 time points: before and after 6 weeks SCP

    resting state connectivity to seed region right anterior insula

Study contacts

Contact information is provided by the study sponsor or research team.

Gordon Feld, Dr.

CONTACT

[email protected]

+49-621/1703 ext. 6540

Sabine Vollstädt-Klein, Prof. Dr.

CONTACT

[email protected]

+49-621/1703 ext. 3912

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2023
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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