Tobacco Use DisorderNCT03764969
Modification of Goal-directed and Habitual Behavior in Addiction
A study testing standard smoking cessation program (SCP), Cognitive remediation treatment (CRT) and Implicit computer-based habit-modifying training (ICHT) in people with Tobacco Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
This study aims to examine the modification of the hypothesized imbalance between goal-directed and habitual behavior and its neural correlates in smokers. Two interventions will be used as add-on trainings to a smoking cessation program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- standard smoking cessation program (SCP), Cognitive remediation treatment (CRT) and Implicit computer-based habit-modifying training (ICHT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jan 2020to 23 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
- severe tobacco use disorder (TUD) according to DSM-5
- sufficient ability to communicate with investigators and answer questions in both written and verbal format
- ability to provide fully informed consent and to use self-rating scales
Who cannot join
- severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months
- history of brain injury
- severe physical diseases
- common exclusion criteria for MRI (e.g. metal, claustrophobia)
- positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
- psychotropic medication within the last 14 days
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttemberg, 68159
About this study
Official title: Modification of the Imbalance Between Goal-directed and Habitual Behavior in Human Addiction
This study aims to examine the modification of the hypothesized imbalance between goal-directed and habitual behavior and its neural correlates in smokers. Two interventions will be used as add-on trainings to a smoking cessation program.
Read the detailed description
In this study, the investigators aim to assess the imbalance between goal-directed and habitual behavior, its neural basis and how it can be differentially modified in treatment-seeking smokers, using two training interventions. The first intervention is cognitive remediation treatment (CRT), also known as cognitive enhancement therapy, focusing on improving inhibitory control and executive functions. The second intervention, a computer-based habit-modifying training focusing on implicit drug seeking ("implicit computer-based habit-modifying training", ICHT) uses a conditioning approach through implicit priming and contextual modulation. Indicators of the imbalance will be examined with respect to reward devaluation, cue reactivity and a pavlovian instrumental transfer (PIT) paradigm. The investigators hypothesize that both interventions change the balance between goal-directed and habitual behavior but by different mechanisms. Whereas CRT should directly increase cognitive control, in contrast, ICHT should affect the early processing and the emotional valence of smoking and smoking cues.
- Conditions
- Tobacco Use Disorder
- Being tested
- standard smoking cessation program (SCP), Cognitive remediation treatment (CRT), Implicit computer-based habit-modifying training (ICHT)
- Keywords
- Addiction, Nicotine, Smoking Cessation, Relapse, Craving, habitual behavior, cognitive remediation, implicit priming, pavlovian instrumental transfer
- Medical subject headings
- Tobacco Use Disorder, Behavior, Addictive, Smoking Cessation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard smoking cessation program (SCP)Behavioural
Each subject will receive standard SCP as group treatment once a week (1 hour) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra \& Buchkremer 2004), and will be carried out by a qualified therapist.
Cognitive remediation treatment (CRT)Behavioural
Cognitive remediation treatment (CRT) employing a chess-based battery of tasks two times per week over six weeks as a group treatment in our outpatient clinic (60 min duration per session).
Implicit computer-based habit-modifying training (ICHT)Behavioural
Implicit computer-based habit-modifying training (ICHT), applied twice a week for six weeks. In this training, the participants perform a two-part training. First, a subliminal presentation (20 ms) of negative valenced primes before smoking-cues in context and secondly, a subliminal presentation of positive valenced primes before potentially reinforcing events.
| Study group | Role | What they receive |
|---|---|---|
| standard smoking cessation program (SCP) | Active comparator | standard smoking cessation program Receives: Behavioral: standard smoking cessation program (SCP) |
| SCP + CRT | Experimental | SCP plus cognitive remediation treatment (CRT) Receives: Behavioral: standard smoking cessation program (SCP); Behavioral: Cognitive remediation treatment (CRT) |
| SCP + ICHT | Experimental | SCP plus an implicit computer-based habit-modifying training (ICHT) Receives: Behavioral: standard smoking cessation program (SCP); Behavioral: Implicit computer-based habit-modifying training (ICHT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in imbalance between goal-directed and habitual behavior
measured by reward devaluation procedure (Hogarth \& Chase 2011)
Measured: 2 time points: before and after 6 weeks SCP
Change in implicit smoking-related associations
smoking-related implicit association task (Wiers et al. 2016).
Measured: 3 time points: before and after 6 weeks SCP plus after 3 months
Change in attentional bias to smoking cues
smoking-related dot-probe task (Vollstädt-Klein et al. 2009).
Measured: 3 time points: before and after 6 weeks SCP plus after 3 months
Change in smoking urges
questionnaire of smoking urges (QSU, Müller et al. 2001)); self-report questionnaire; two subscales: "intention and desire to smoke / anticipation of pleasure from smoking" (range 11 - 77) and "anticipation of relief from negative affect and nicotine withdrawal / urgent and overwhelming desire to smoke" (range 10 - 70) high values represent high craving
Measured: 3 time points: before and after 6 weeks SCP plus after 3 months
Change in working memory capacity
Spatial Working Memory task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Measured: 3 time points: before and after 6 weeks SCP plus after 3 months
Change in planning ability
One Touch Stockings of Cambridge task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Measured: 3 time points: before and after 6 weeks SCP plus after 3 months
Change in cognitive flexibility
Internal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Measured: 3 time points: before and after 6 weeks SCP plus after 3 months
Secondary outcomes (3)
nicotine consumption
self-report
Measured: 3 months follow-up
Change in neural PIT effect
PIT phase of a choice task (adapted from Hogarth \& Chase 2011)
Measured: 2 time points: before and after 6 weeks SCP
Change in neural cue reactivity
fMRI cue-reactivity task (Vollstädt-Klein et al. 2011)
Measured: 2 time points: before and after 6 weeks SCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start7 Jan 2020
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Vollstädt-Klein, Prof. Dr., Principal investigator, Central Institute of Mental Health, MannheimHerta Flor, Prof. Dr., Principal investigator, Central Institute of Mental Health, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764969
- Sponsor's protocol ID
- TRR265 C01
- Status last verified
- Oct 2023
- First submitted
- 28 Nov 2018
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karl D, Wieland A, Shevchenko Y, Grundinger N, Machunze N, Gerhardt S, Flor H, Vollstadt-Klein S. Using computer-based habit versus chess-based cognitive remediation training as add-on therapy to modify the imbalance between habitual behavior and cognitive control in tobacco use disorder: protocol of a randomized controlled, fMRI study. BMC Psychol. 2023 Jan 25;11(1):24. doi: 10.1186/s40359-023-01055-z.
PubMed 36698210
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of the Imbalance Between Goal-directed and Habitual Behavior in Human Addiction
- ClinicalTrials.gov ID
- NCT03764969
- Acronym / sponsor ID
- TRR265 C01
- Conditions
- Tobacco Use Disorder
- Keywords
- Addiction, Nicotine, Smoking Cessation, Relapse, Craving, habitual behavior, cognitive remediation, implicit priming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 5 Dec 2018 (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 aims to examine the modification of the hypothesized imbalance between goal-directed and habitual behavior and its neural correlates in smokers. Two interventions will be used as add-on trainings to a smoking cessation program.
Detailed description
In this study, the investigators aim to assess the imbalance between goal-directed and habitual behavior, its neural basis and how it can be differentially modified in treatment-seeking smokers, using two training interventions. The first intervention is cognitive remediation treatment (CRT), also known as cognitive enhancement therapy, focusing on improving inhibitory control and executive functions. The second intervention, a computer-based habit-modifying training focusing on implicit drug seeking ("implicit computer-based habit-modifying training", ICHT) uses a conditioning approach through implicit priming and contextual modulation. Indicators of the imbalance will be examined with respect to reward devaluation, cue reactivity and a pavlovian instrumental transfer (PIT) paradigm. The investigators hypothesize that both interventions change the balance between goal-directed and habitual behavior but by different mechanisms. Whereas CRT should directly increase cognitive control, in contrast, ICHT should affect the early processing and the emotional valence of smoking and smoking cues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard smoking cessation program (SCP) | Active comparator | Behavioral: standard smoking cessation program (SCP)standard smoking cessation program |
| SCP + CRT | Experimental | Behavioral: standard smoking cessation program (SCP), Behavioral: Cognitive remediation treatment (CRT)SCP plus cognitive remediation treatment (CRT) |
| SCP + ICHT | Experimental | Behavioral: standard smoking cessation program (SCP), Behavioral: Implicit computer-based habit-modifying training (ICHT)SCP plus an implicit computer-based habit-modifying training (ICHT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- severe tobacco use disorder (TUD) according to DSM-5
- sufficient ability to communicate with investigators and answer questions in both written and verbal format
- ability to provide fully informed consent and to use self-rating scales
Key exclusion criteria (7 listed)
- severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months
- history of brain injury
- severe physical diseases
- common exclusion criteria for MRI (e.g. metal, claustrophobia)
- positive drug screening (opioids, benzodiazepines, barbiturates, 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 |
|---|---|---|
| standard smoking cessation program (SCP)Each subject will receive standard SCP as group treatment once a week (1 hour) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra \& Buchkremer 2004), and will be carried out by a qualified therapist. | Behavioural | SCP + CRT, SCP + ICHT, standard smoking cessation program (SCP) |
| Cognitive remediation treatment (CRT)Cognitive remediation treatment (CRT) employing a chess-based battery of tasks two times per week over six weeks as a group treatment in our outpatient clinic (60 min duration per session). | Behavioural | SCP + CRT |
| Implicit computer-based habit-modifying training (ICHT)Implicit computer-based habit-modifying training (ICHT), applied twice a week for six weeks. In this training, the participants perform a two-part training. First, a subliminal presentation (20 ms) of negative valenced primes before smoking-cues in context and secondly, a subliminal presentation of positive valenced primes before potentially reinforcing events. | Behavioural | SCP + ICHT |
Primary outcome
Change in imbalance between goal-directed and habitual behavior
Time frame: 2 time points: before and after 6 weeks SCP
measured by reward devaluation procedure (Hogarth \& Chase 2011)
Change in implicit smoking-related associations
Time frame: 3 time points: before and after 6 weeks SCP plus after 3 months
smoking-related implicit association task (Wiers et al. 2016).
Change in attentional bias to smoking cues
Time frame: 3 time points: before and after 6 weeks SCP plus after 3 months
smoking-related dot-probe task (Vollstädt-Klein et al. 2009).
Change in smoking urges
Time frame: 3 time points: before and after 6 weeks SCP plus after 3 months
questionnaire of smoking urges (QSU, Müller et al. 2001)); self-report questionnaire; two subscales: "intention and desire to smoke / anticipation of pleasure from smoking" (range 11 - 77) and "anticipation of relief from negative affect and nicotine withdrawal / urgent and overwhelming desire to smoke" (range 10 - 70) high values represent high craving
Change in working memory capacity
Time frame: 3 time points: before and after 6 weeks SCP plus after 3 months
Spatial Working Memory task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Change in planning ability
Time frame: 3 time points: before and after 6 weeks SCP plus after 3 months
One Touch Stockings of Cambridge task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Change in cognitive flexibility
Time frame: 3 time points: before and after 6 weeks SCP plus after 3 months
Internal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
3 secondary outcomes
nicotine consumption
Time frame: 3 months follow-up
Change in neural PIT effect
Time frame: 2 time points: before and after 6 weeks SCP
Change in neural cue reactivity
Time frame: 2 time points: before and after 6 weeks SCP
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 5 Oct 2023.
- Derived from this study: PubMed 36698210Karl D, Wieland A, Shevchenko Y, Grundinger N, Machunze N, Gerhardt S, Flor H, Vollstadt-Klein S. Using computer-based habit versus chess-based cognitive remediation training as add-on therapy to modify the imbalance between habitual behavior and cognitive control in tobacco use disorder: protocol of a randomized controlled, fMRI study. BMC Psychol. 2023 Jan 25;11(1):24. doi: 10.1186/s40359-023-01055-z.
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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.
Sabine Vollstädt-Klein, Prof. Dr. principal investigator
Central Institute of Mental Health, Mannheim
Herta Flor, Prof. Dr. principal investigator
Central Institute of Mental Health, Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard smoking cessation program (SCP), Cognitive remediation treatment (CRT) and Implicit computer-based habit-modifying training (ICHT) in people with Tobacco Use Disorder, run by Central Institute of Mental Health, Mannheim 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 3 inclusion and 7 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 5 Oct 2023. 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 imbalance between goal-directed and habitual behavior (time frame: 2 time points: before and after 6 weeks SCP). The study lists 7 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 NCT03764969, which also lists 1 linked publication.
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 5 Oct 2023.