Skip to main content
OpenTrials
Completed

NCT Number: NCT04251936

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Behavior Chemically-Induced Disorders Mental Disorders Motor Activity Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training

Behavioral

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.

Smoking cessation group program

Behavioral

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 5, 2020
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.