Tobacco Use DisorderNCT05726045
Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation
A study testing Standard smoking cessation program (SCP), Cognitive remediation treatment (CRT) and High-intensity interval training (HIIT evening) in people with Tobacco Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Standard smoking cessation program (SCP), Cognitive remediation treatment (CRT) and High-intensity interval training (HIIT evening)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttemberg, 68159
Sabine Vollstädt-Klein, Prof. Dr., s.vollstaedt-klein@zi-mannheim.de
About this study
Official title: Increasing the Smoking Cessation Success Rate by Enhancing Improvement of Self-control 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.
Read the 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Standard smoking cessation program (SCP), Cognitive remediation treatment (CRT), High-intensity interval training (HIIT evening)
- Keywords
- Addiction, Nicotine, Smoking Cessation, Relapse, Cognitive remediation, Exercise training
- Medical subject headings
- Tobacco Use Disorder, Behavior, Addictive, Smoking Cessation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard smoking cessation program (SCP)Behavioural
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)Behavioural
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| HIIT morning | Active comparator | High-intensity interval training (HIIT) in the morning Receives: Behavioral: Standard smoking cessation program (SCP) |
| HIIT evening | Experimental | High-intensity interval training (HIIT) in the evening Receives: Behavioral: Standard smoking cessation program (SCP); Behavioral: High-intensity interval training (HIIT evening) |
| HIIT morning + CRT | Active comparator | High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT) Receives: Behavioral: Standard smoking cessation program (SCP); Behavioral: Cognitive remediation treatment (CRT) |
| HIIT evening + CRT | Experimental | High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT) Receives: Behavioral: Standard smoking cessation program (SCP); Behavioral: Cognitive remediation treatment (CRT); Behavioral: High-intensity interval training (HIIT evening) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until first severe relapse
days until the first severe smoking relapse after treatment
Measured: timepoint 3: follow-up 3 months after end of SCP
Percentage of abstinent days
Percentage of abstinent days in the 3 months after treatment
Measured: timepoint 3: follow-up 3 months after end of SCP
Change in smoking urges
questionnaire of smoking urges (QSU, Müller et al. 2001)
Measured: 2 time points: before and after 6 weeks SCP
Change in neural measures of response inhibition
SST fMRI task (Gan et al., 2014)
Measured: 2 time points: before and after 6 weeks SCP
Change in neural measures of working memory
Nback fMRI task (Charlet et al., 2014)
Measured: 2 time points: before and after 6 weeks SCP
Change in neural functional connectivity in the salience network
resting state connectivity to seed region right anterior insula
Measured: 2 time points: before and after 6 weeks SCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Apr 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Vollstädt-Klein, Prof. Dr., Principal investigator, Central Institute of Mental Health, MannheimGordon Feld, Dr., Principal investigator, Central Institute of Mental Health, MannheimKaren Ersche, Prof. Dr., Principal investigator, Central Institute of Mental Health, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726045
- Sponsor's protocol ID
- TRR265 C01-P2
- Status last verified
- Jan 2025
- First submitted
- 2 Feb 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gerhardt S, Kroth M, Seeger A, Schmitt R, Fritz H, Diring L, Shevchenko Y, Ersche KD, Feld G, Vollstadt-Klein S. Increasing the smoking cessation success rate by enhancing improvement of self-control through sleep-amplified memory consolidation: protocol of a randomized controlled, functional magnetic resonance study. BMC Psychol. 2025 Feb 22;13(1):157. doi: 10.1186/s40359-025-02482-w.
PubMed 39987116
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Smoking Cessation Success Rate by Enhancing Improvement of Self-control Through Sleep-amplified Memory Consolidation
- ClinicalTrials.gov ID
- NCT05726045
- Acronym / sponsor ID
- TRR265 C01-P2
- Conditions
- Tobacco Use Disorder
- Keywords
- Addiction, Nicotine, Smoking Cessation, Relapse, Cognitive remediation, Exercise training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIIT morning | Active comparator | Behavioral: Standard smoking cessation program (SCP)High-intensity interval training (HIIT) in the morning |
| HIIT evening | Experimental | Behavioral: Standard smoking cessation program (SCP), Behavioral: High-intensity interval training (HIIT evening)High-intensity interval training (HIIT) in the evening |
| HIIT morning + CRT | Active comparator | Behavioral: Standard smoking cessation program (SCP), Behavioral: Cognitive remediation treatment (CRT)High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT) |
| HIIT evening + CRT | Experimental | Behavioral: Standard smoking cessation program (SCP), Behavioral: Cognitive remediation treatment (CRT), Behavioral: High-intensity interval training (HIIT evening)High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | HIIT evening, HIIT evening + CRT, HIIT morning, HIIT morning + CRT |
| 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). | Behavioural | HIIT evening + CRT, HIIT morning + CRT |
| 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). | Behavioural | HIIT evening, HIIT evening + CRT |
Primary outcome
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
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
Change in smoking urges
Time frame: 2 time points: before and after 6 weeks SCP
questionnaire of smoking urges (QSU, Müller et al. 2001)
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)
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 39987116Gerhardt S, Kroth M, Seeger A, Schmitt R, Fritz H, Diring L, Shevchenko Y, Ersche KD, Feld G, Vollstadt-Klein S. Increasing the smoking cessation success rate by enhancing improvement of self-control through sleep-amplified memory consolidation: protocol of a randomized controlled, functional magnetic resonance study. BMC Psychol. 2025 Feb 22;13(1):157. doi: 10.1186/s40359-025-02482-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabine Vollstädt-Klein, Prof. Dr. principal investigator
Central Institute of Mental Health, Mannheim
Gordon Feld, Dr. principal investigator
Central Institute of Mental Health, Mannheim
Karen Ersche, Prof. Dr. principal investigator
Central Institute of Mental Health, Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard smoking cessation program (SCP), Cognitive remediation treatment (CRT) and High-intensity interval training (HIIT evening) in people with Tobacco Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Vollstädt-Klein, Prof. Dr. (+49-621/1703 ext. 3912, s.vollstaedt-klein@zi-mannheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until first severe relapse (time frame: timepoint 3: follow-up 3 months after end of SCP). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05726045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.