Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder
Primary Purpose
Healthy, Tobacco Use Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise training
Smoking cessation group program
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring tobacco use disorder, fMRI, physical exercise, reward system, cognitive control
Eligibility Criteria
Inclusion Criteria:
- Tobacco use disorder according to DSM-5
- right-handedness
- sufficient ability to communicate with investigators
- ability to provide informed consent and to use self-rating scales
- seeking treatment for TUD
- no contra-indication for aerobic exercise
Exclusion Criteria:
- severe internal or neurological comorbidities
- axis I mental disorders other than TUD (except for mild depression, adjustment disorder and specific phobias) in the last 12 months according to DSM-5
- history of brain injury
- pregnancy
- exclusion criteria for MRI
- positive drug screening (opioids, benzodiazepines, cocaine, amphetamines)
- psychotropic medication within the last 14 days
Sites / Locations
- Charité Universitätsmedizin BerlinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise training plus smoking cessation group program
Smoking cessation group program
Arm Description
Outcomes
Primary Outcome Measures
Change in nicotine consumption from pre-intervention to post-intervention
self-report
Change in nicotine consumption from pre-intervention to follow-up
self-report
Change in BOLD during cue reactivity task (fMRI) from pre-intervention to post-intervention
Blood Oxygen Level Dependent especially within the ventral striatum, the ventral medial prefrontal cortex and the amygdala during a cue reactivity task with neutral, tobacco, alternative reward images and warning images depicting aversive consequences of smoking
Change in BOLD during down-regulation of craving task (fMRI) from pre-intervention to post-intervention
Blood Oxygen Level Dependent especially within the ventral striatum, the amygdala and the dorsolateral prefrontal cortex during a cognitive down-regulation of craving task with tobacco and alternative reward stimuli
Change in BOLD during stop-signal task (fMRI) from pre-intervention to post-intervention
Blood Oxygen Level Dependent especially within the dorsolateral prefrontal cortex during a stop signal task
Change in craving ratings (behavioral) from pre-intervention to post-intervention
The participants' answers to the question "how strong is your desire to consume the item shown" on a scale of 1 - 8 is averaged over a total of 144 pictures of nicotine and alternative reward stimuli. The change in average ratings between pre-intervention and post-intervention is computed.
Change in down-regulation of craving (behavioral) from pre-intervention to post-intervention
The down-regulation of craving task is carried out as described in Kober et al., 2010. As described there, the down-regulation of craving is calculated as the difference in craving ratings between the now and later condition (20 nicotine and alternative reward stimuli are shown in the now and later condition). The change in the down-regulation of craving between pre- and post-intervention is then calculated.
Change in stop-signal reaction time (behavioral) from pre-intervention to post-intervention
Stop-signal reaction time in the stop-signal task
Secondary Outcome Measures
Full Information
NCT ID
NCT04251936
First Posted
January 16, 2020
Last Updated
August 13, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
Prof. Dr. Felix Bermpohl, Co-PI
1. Study Identification
Unique Protocol Identification Number
NCT04251936
Brief Title
Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder
Official Title
Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Prof. Dr. Felix Bermpohl, Co-PI
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
This study investigates the mechanisms, through which physical exercise impacts positively on abstinence in tobacco use disorder, with fMRI and behavioral tests.
Detailed Description
This study will test the hypothesis that physical exercise training modifies alternative reward cue reactivity and cognitive control in tobacco use disorder and that these modifications mediate the effect of exercise on abstinence. Continued physical exercise training was shown to reduce tobacco consumption and prevent relapse in tobacco use disorder (TUD). However, the psychological and neural mechanisms through which exercise training exerts its effects on tobacco consumption are not clear. The aim of this project is to identify the effects of a 12-week aerobic exercise training in TUD and to test how these exercise-related changes may mediate the effect of exercise training on abstinence. Investigations will focus on two potential mechanisms of regaining control: (1) modifications of tobacco and alternative reward cue reactivity and (2) improvement of cognitive control. Two aspects of cognitive control will be addressed: inhibitory control and cognitive down-regulation of craving. It is expected, first, that exercise training (compared to standard treatment) leads to desensitization towards tobacco cues and sensitization towards alternative reward cues, reflected in altered craving and neural (fMRI) cue reactivity. Second, it is expected that exercise training will lead to increased cognitive control (i.e., inhibitory control and cognitive down-regulation of craving), reflected in increased activation of prefrontal control regions (fMRI). Third, it is expected that effects of exercise on abstinence will be mediated by sensitization towards alternative reward cues and enhanced cognitive control. In an exploratory manner, gender differences in the effects of exercise training will be studied. Understanding the psychological and neural underpinnings will help to optimize and individualize exercise trainings in TUD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Tobacco Use Disorder
Keywords
tobacco use disorder, fMRI, physical exercise, reward system, cognitive control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise training plus smoking cessation group program
Arm Type
Experimental
Arm Title
Smoking cessation group program
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
The moderate-intense aerobic exercise training will involve supervised aerobicycle ergometer training for 30 min with 60-80% HRmax three times per week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation group program
Intervention Description
Participants of both groups will receive a 6-week standard cognitive behavioral therapy-oriented smoking cessation group program (SCP, one 60 min session per week).
Primary Outcome Measure Information:
Title
Change in nicotine consumption from pre-intervention to post-intervention
Description
self-report
Time Frame
Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Title
Change in nicotine consumption from pre-intervention to follow-up
Description
self-report
Time Frame
Pre-intervention and follow-up (12 weeks after intervention end)
Title
Change in BOLD during cue reactivity task (fMRI) from pre-intervention to post-intervention
Description
Blood Oxygen Level Dependent especially within the ventral striatum, the ventral medial prefrontal cortex and the amygdala during a cue reactivity task with neutral, tobacco, alternative reward images and warning images depicting aversive consequences of smoking
Time Frame
Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Title
Change in BOLD during down-regulation of craving task (fMRI) from pre-intervention to post-intervention
Description
Blood Oxygen Level Dependent especially within the ventral striatum, the amygdala and the dorsolateral prefrontal cortex during a cognitive down-regulation of craving task with tobacco and alternative reward stimuli
Time Frame
Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Title
Change in BOLD during stop-signal task (fMRI) from pre-intervention to post-intervention
Description
Blood Oxygen Level Dependent especially within the dorsolateral prefrontal cortex during a stop signal task
Time Frame
Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Title
Change in craving ratings (behavioral) from pre-intervention to post-intervention
Description
The participants' answers to the question "how strong is your desire to consume the item shown" on a scale of 1 - 8 is averaged over a total of 144 pictures of nicotine and alternative reward stimuli. The change in average ratings between pre-intervention and post-intervention is computed.
Time Frame
Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Title
Change in down-regulation of craving (behavioral) from pre-intervention to post-intervention
Description
The down-regulation of craving task is carried out as described in Kober et al., 2010. As described there, the down-regulation of craving is calculated as the difference in craving ratings between the now and later condition (20 nicotine and alternative reward stimuli are shown in the now and later condition). The change in the down-regulation of craving between pre- and post-intervention is then calculated.
Time Frame
Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Title
Change in stop-signal reaction time (behavioral) from pre-intervention to post-intervention
Description
Stop-signal reaction time in the stop-signal task
Time Frame
Pre-intervention and post-intervention (up to 2 weeks after intervention end)
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:
Tobacco use disorder according to DSM-5
right-handedness
sufficient ability to communicate with investigators
ability to provide informed consent and to use self-rating scales
seeking treatment for TUD
no contra-indication for aerobic exercise
Exclusion Criteria:
severe internal or neurological comorbidities
axis I mental disorders other than TUD (except for mild depression, adjustment disorder and specific phobias) in the last 12 months according to DSM-5
history of brain injury
pregnancy
exclusion criteria for MRI
positive drug screening (opioids, benzodiazepines, cocaine, amphetamines)
psychotropic medication within the last 14 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Ströhle, Prof.
Phone
+49 30 450 517 034
Email
andreas.stroehle@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Bermpohl, Prof.
Email
felix.bermpohl@charite.de
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Ströhle, Prof.
Email
andreas.stroehle@charite.de
First Name & Middle Initial & Last Name & Degree
Felix Bermpohl, Prof.
Email
felix.bermpohl@charite.de
First Name & Middle Initial & Last Name & Degree
Stefanie Kunas
First Name & Middle Initial & Last Name & Degree
Heiner Stuke, Dr.
12. IPD Sharing Statement
Citations:
PubMed Identifier
20679212
Citation
Kober H, Mende-Siedlecki P, Kross EF, Weber J, Mischel W, Hart CL, Ochsner KN. Prefrontal-striatal pathway underlies cognitive regulation of craving. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14811-6. doi: 10.1073/pnas.1007779107. Epub 2010 Aug 2.
Results Reference
background
PubMed Identifier
35175067
Citation
Kunas SL, Stuke H, Plank IS, Laing EM, Bermpohl F, Strohle A. Neurofunctional alterations of cognitive down-regulation of craving in quitting motivated smokers. Psychol Addict Behav. 2022 Dec;36(8):1012-1022. doi: 10.1037/adb0000820. Epub 2022 Feb 17.
Results Reference
derived
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Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder
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