Modification of Goal-directed and Habitual Behavior in Addiction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Modification of the Imbalance Between Goal-directed and Habitual Behavior in Human Addiction

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: standard smoking cessation program (SCP)
* Behavioral: Cognitive remediation treatment (CRT)
* Behavioral: Implicit computer-based habit-modifying training (ICHT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard smoking cessation program (SCP)<br>standard smoking cessation program | Behavioral: standard smoking cessation program (SCP)<br>* 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.<br>|
| Experimental: SCP + CRT<br>SCP plus cognitive remediation treatment (CRT) | Behavioral: standard smoking cessation program (SCP)<br>* 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.<br>Behavioral: Cognitive remediation treatment (CRT)<br>* 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).<br>|
| Experimental: SCP + ICHT<br>SCP plus an implicit computer-based habit-modifying training (ICHT) | Behavioral: standard smoking cessation program (SCP)<br>* 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.<br>Behavioral: Implicit computer-based habit-modifying training (ICHT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in imbalance between goal-directed and habitual behavior | measured by reward devaluation procedure (Hogarth & Chase 2011) | 2 time points: before and after 6 weeks SCP | 
| Change in implicit smoking-related associations | smoking-related implicit association task (Wiers et al. 2016). | 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). | 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 | 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) | 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) | 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) | 3 time points: before and after 6 weeks SCP plus after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nicotine consumption | self-report | 3 months follow-up | 
| Change in neural PIT effect | PIT phase of a choice task (adapted from Hogarth & Chase 2011) | 2 time points: before and after 6 weeks SCP | 
| Change in neural cue reactivity | fMRI cue-reactivity task (Vollstädt-Klein et al. 2011) | 2 time points: before and after 6 weeks SCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Addiction, Nicotine, Smoking Cessation, Relapse, Craving, habitual behavior, cognitive remediation, implicit priming, pavlovian instrumental transfer