Clinical trial NCT05726045: Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation
Official title: Increasing the Smoking Cessation Success Rate by Enhancing Improvement of Self-control Through Sleep-amplified Memory Consolidation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Addiction
Nicotine
Smoking Cessation
Relapse
Cognitive remediation
Exercise training
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time until first severe relapse
timeFrame: timepoint 3: follow-up 3 months after end of SCP
measure: Percentage of abstinent days
timeFrame: timepoint 3: follow-up 3 months after end of SCP
measure: Change in smoking urges
timeFrame: 2 time points: before and after 6 weeks SCP
measure: Change in neural measures of response inhibition
timeFrame: 2 time points: before and after 6 weeks SCP
measure: Change in neural measures of working memory
timeFrame: 2 time points: before and after 6 weeks SCP
measure: Change in neural functional connectivity in the salience network
timeFrame: 2 time points: before and after 6 weeks SCP
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
state: Baden-Württemberg
Study officials:
affiliation: Central Institute of Mental Health, Mannheim
name: Sabine Vollstädt-Klein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Institute of Mental Health, Mannheim
name: Gordon Feld, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Institute of Mental Health, Mannheim
name: Karen Ersche, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: