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

NCT04251936 | Completed

• 1 other identifier: TRR265 C03
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Tobacco Use Disorder

Keywords

tobacco use disorder; fMRI; physical exercise; reward system; cognitive control

Outcome Measures

Primary Outcomes (8)

• Change in nicotine consumption from pre-intervention to post-intervention

  self-report

  Pre-intervention and post-intervention (up to 2 weeks after intervention end)

• Change in nicotine consumption from pre-intervention to follow-up

  self-report

  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

  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

  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

  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.

  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.

  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

  Pre-intervention and post-intervention (up to 2 weeks after intervention end)

Study Arms (2)

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

Interventions

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.

Exercise training plus smoking cessation group program

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).

Exercise training plus smoking cessation group program; Smoking cessation group program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (2)

• 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.

  PMID: 20679212 BACKGROUND

• 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.

  PMID: 35175067 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: February 5, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

DE (1)