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Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

Primary Purpose

Tobacco Use Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Standard smoking cessation program (SCP)
Cognitive remediation treatment (CRT)
High-intensity interval training (HIIT evening)
Sponsored by
Central Institute of Mental Health, Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Addiction, Nicotine, Smoking Cessation, Relapse, Cognitive remediation, Exercise training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

HIIT morning

HIIT evening

HIIT morning + CRT

HIIT evening + CRT

Arm Description

High-intensity interval training (HIIT) in the morning

High-intensity interval training (HIIT) in the evening

High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT)

High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)

Outcomes

Primary Outcome Measures

Time until first severe relapse
days until the first severe smoking relapse after treatment
Percentage of abstinent days
Percentage of abstinent days in the 3 months after treatment
Change in smoking urges
questionnaire of smoking urges (QSU, Müller et al. 2001)
Change in neural measures of response inhibition
SST fMRI task (Gan et al., 2014)
Change in neural measures of working memory
Nback fMRI task (Charlet et al., 2014)
Change in neural functional connectivity in the salience network
resting state connectivity to seed region right anterior insula

Secondary Outcome Measures

Full Information

First Posted
February 2, 2023
Last Updated
February 2, 2023
Sponsor
Central Institute of Mental Health, Mannheim
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1. Study Identification

Unique Protocol Identification Number
NCT05726045
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Institute of Mental Health, Mannheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Addiction, Nicotine, Smoking Cessation, Relapse, Cognitive remediation, Exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIIT morning
Arm Type
Active Comparator
Arm Description
High-intensity interval training (HIIT) in the morning
Arm Title
HIIT evening
Arm Type
Experimental
Arm Description
High-intensity interval training (HIIT) in the evening
Arm Title
HIIT morning + CRT
Arm Type
Active Comparator
Arm Description
High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT)
Arm Title
HIIT evening + CRT
Arm Type
Experimental
Arm Description
High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)
Intervention Type
Behavioral
Intervention Name(s)
Standard smoking cessation program (SCP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation treatment (CRT)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval training (HIIT evening)
Intervention Description
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 Outcome Measure Information:
Title
Time until first severe relapse
Description
days until the first severe smoking relapse after treatment
Time Frame
timepoint 3: follow-up 3 months after end of SCP
Title
Percentage of abstinent days
Description
Percentage of abstinent days in the 3 months after treatment
Time Frame
timepoint 3: follow-up 3 months after end of SCP
Title
Change in smoking urges
Description
questionnaire of smoking urges (QSU, Müller et al. 2001)
Time Frame
2 time points: before and after 6 weeks SCP
Title
Change in neural measures of response inhibition
Description
SST fMRI task (Gan et al., 2014)
Time Frame
2 time points: before and after 6 weeks SCP
Title
Change in neural measures of working memory
Description
Nback fMRI task (Charlet et al., 2014)
Time Frame
2 time points: before and after 6 weeks SCP
Title
Change in neural functional connectivity in the salience network
Description
resting state connectivity to seed region right anterior insula
Time Frame
2 time points: before and after 6 weeks SCP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Vollstädt-Klein, Prof. Dr.
Phone
+49-621/1703
Ext
3912
Email
s.vollstaedt-klein@zi-mannheim.de
First Name & Middle Initial & Last Name or Official Title & Degree
Gordon Feld, Dr.
Phone
+49-621/1703
Ext
6540
Email
gordon.feld@zi-mannheim.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Vollstädt-Klein, Prof. Dr.
Organizational Affiliation
Central Institute of Mental Health, Mannheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gordon Feld, Dr.
Organizational Affiliation
Central Institute of Mental Health, Mannheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Ersche, Prof. Dr.
Organizational Affiliation
Central Institute of Mental Health, Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68159
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Vollstädt-Klein, Prof. Dr.
Email
s.vollstaedt-klein@zi-mannheim.de

12. IPD Sharing Statement

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Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

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