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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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Charité University Medicine Berlin

Status

Completed

Conditions

Healthy
Tobacco Use Disorder

Treatments

Behavioral: Exercise training
Behavioral: Smoking cessation group program

Study type

Interventional

Funder types

Other

Identifiers

NCT04251936
TRR265 C03

Details and patient eligibility

About

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

Full 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.

Enrollment

82 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 2 patient groups

Exercise training plus smoking cessation group program
Experimental group
Treatment:
Behavioral: Smoking cessation group program
Behavioral: Exercise training
Smoking cessation group program
Active Comparator group
Treatment:
Behavioral: Smoking cessation group program

Trial contacts and locations

1

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Central trial contact

Andreas Ströhle, Prof.; Felix Bermpohl, Prof.

Data sourced from clinicaltrials.gov

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