Clinical trial NCT04251936: 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
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Tobacco Use Disorder
Keywords: tobacco use disorder
fMRI
physical exercise
reward system
cognitive control
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in nicotine consumption from pre-intervention to post-intervention
timeFrame: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
measure: Change in nicotine consumption from pre-intervention to follow-up
timeFrame: Pre-intervention and follow-up (12 weeks after intervention end)
measure: Change in BOLD during cue reactivity task (fMRI) from pre-intervention to post-intervention
timeFrame: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
measure: Change in BOLD during down-regulation of craving task (fMRI) from pre-intervention to post-intervention
timeFrame: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
measure: Change in BOLD during stop-signal task (fMRI) from pre-intervention to post-intervention
timeFrame: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
measure: Change in craving ratings (behavioral) from pre-intervention to post-intervention
timeFrame: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
measure: Change in down-regulation of craving (behavioral) from pre-intervention to post-intervention
timeFrame: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
measure: Change in stop-signal reaction time (behavioral) from pre-intervention to post-intervention
timeFrame: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
References:
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.
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.