HealthyNCT04251936
Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder
A study testing Exercise training and Smoking cessation group program in people with Healthy and Tobacco Use Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study investigates the mechanisms, through which physical exercise impacts positively on abstinence in tobacco use disorder, with fMRI and behavioral tests. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy, Tobacco Use Disorder
- What is being tested?
- Exercise training and Smoking cessation group program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- positive drug screening (opioids, benzodiazepines, cocaine, amphetamines)
- psychotropic medication within the last 14 days
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the mechanisms, through which physical exercise impacts positively on abstinence in tobacco use disorder, with fMRI and behavioral tests.
Read the 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.
- Conditions
- Healthy, Tobacco Use Disorder
- Being tested
- Exercise training, Smoking cessation group program
- Keywords
- tobacco use disorder, fMRI, physical exercise, reward system, cognitive control
- Medical subject headings
- Tobacco Use Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
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 programBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Exercise training plus smoking cessation group program | Experimental | Not described Receives: Behavioral: Exercise training; Behavioral: Smoking cessation group program |
| Smoking cessation group program | Active comparator | Not described Receives: Behavioral: Smoking cessation group program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nicotine consumption from pre-intervention to post-intervention
self-report
Measured: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Change in nicotine consumption from pre-intervention to follow-up
self-report
Measured: Pre-intervention and follow-up (12 weeks after intervention end)
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
Measured: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
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
Measured: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
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
Measured: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
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.
Measured: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
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.
Measured: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Change in stop-signal reaction time (behavioral) from pre-intervention to post-intervention
Stop-signal reaction time in the stop-signal task
Measured: Pre-intervention and post-intervention (up to 2 weeks after intervention end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251936
- Sponsor's protocol ID
- TRR265 C03
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20679212Kunas 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.
PubMed 35175067
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Alternative Reward Cue Reactivity and Cognitive Control Through Physical Activity in Human Tobacco Use Disorder
- ClinicalTrials.gov ID
- NCT04251936
- Acronym / sponsor ID
- TRR265 C03
- Conditions
- Healthy, Tobacco Use Disorder
- Keywords
- tobacco use disorder, fMRI, physical exercise, reward system, cognitive control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training plus smoking cessation group program | Experimental | Behavioral: Exercise training, Behavioral: Smoking cessation group program |
| Smoking cessation group program | Active comparator | Behavioral: Smoking cessation group program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- positive drug screening (opioids, benzodiazepines, cocaine, amphetamines)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingThe 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. | Behavioural | Exercise training plus smoking cessation group program |
| Smoking cessation group programParticipants of both groups will receive a 6-week standard cognitive behavioral therapy-oriented smoking cessation group program (SCP, one 60 min session per week). | Behavioural | Exercise training plus smoking cessation group program, Smoking cessation group program |
Primary outcome
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
Change in nicotine consumption from pre-intervention to follow-up
Time frame: Pre-intervention and follow-up (12 weeks after intervention end)
self-report
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
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
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
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 20679212Kober 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.
- Derived from this study: PubMed 35175067Kunas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training and Smoking cessation group program in people with Healthy and Tobacco Use Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nicotine consumption from pre-intervention to post-intervention (time frame: Pre-intervention and post-intervention (up to 2 weeks after intervention end)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251936, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.