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Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251936
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Prof. Dr. Felix Bermpohl, Co-PI
Information provided by (Responsible Party):
Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany

Brief Summary:
This study investigates the mechanisms, through which physical exercise impacts positively on abstinence in tobacco use disorder, with fMRI and behavioral tests.

Condition or disease Intervention/treatment Phase
Healthy Tobacco Use Disorder Behavioral: Exercise training Behavioral: Smoking cessation group program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise training plus smoking cessation group program Behavioral: Exercise training
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.

Behavioral: Smoking cessation group program
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).

Active Comparator: Smoking cessation group program Behavioral: Smoking cessation group program
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 Measures :
  1. Change in nicotine consumption from pre-intervention to post-intervention [ Time Frame: Pre-intervention and post-intervention (up to 2 weeks after intervention end) ]
    self-report

  2. Change in nicotine consumption from pre-intervention to follow-up [ Time Frame: Pre-intervention and follow-up (12 weeks after intervention end) ]
    self-report

  3. Change in BOLD during cue reactivity task (fMRI) from pre-intervention to post-intervention [ Time Frame: Pre-intervention and post-intervention (up to 2 weeks after intervention end) ]
    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

  4. Change in BOLD during down-regulation of craving task (fMRI) from pre-intervention to post-intervention [ Time Frame: Pre-intervention and post-intervention (up to 2 weeks after intervention end) ]
    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

  5. Change in BOLD during stop-signal task (fMRI) from pre-intervention to post-intervention [ Time Frame: Pre-intervention and post-intervention (up to 2 weeks after intervention end) ]
    Blood Oxygen Level Dependent especially within the dorsolateral prefrontal cortex during a stop signal task

  6. Change in craving ratings (behavioral) from pre-intervention to post-intervention [ Time Frame: Pre-intervention and post-intervention (up to 2 weeks after intervention end) ]
    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.

  7. Change in down-regulation of craving (behavioral) from pre-intervention to post-intervention [ Time Frame: Pre-intervention and post-intervention (up to 2 weeks after intervention end) ]
    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.

  8. Change in stop-signal reaction time (behavioral) from pre-intervention to post-intervention [ Time Frame: Pre-intervention and post-intervention (up to 2 weeks after intervention end) ]
    Stop-signal reaction time in the stop-signal task



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251936


Contacts
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Contact: Andreas Ströhle, Prof. +49 30 450 517 034 andreas.stroehle@charite.de
Contact: Felix Bermpohl, Prof. felix.bermpohl@charite.de

Locations
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Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Andreas Ströhle, Prof.       andreas.stroehle@charite.de   
Contact: Felix Bermpohl, Prof.       felix.bermpohl@charite.de   
Sub-Investigator: Stefanie Kunas         
Sub-Investigator: Heiner Stuke, Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Prof. Dr. Felix Bermpohl, Co-PI
Publications:
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Responsible Party: Prof. Dr. Andreas Ströhle, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04251936    
Other Study ID Numbers: TRR265 C03
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany:
tobacco use disorder
fMRI
physical exercise
reward system
cognitive control
Additional relevant MeSH terms:
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Disease
Tobacco Use Disorder
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders