Clinical trial NCT03764969: Modification of Goal-directed and Habitual Behavior in Addiction
Official title: Modification of the Imbalance Between Goal-directed and Habitual Behavior in Human Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Addiction
Nicotine
Smoking Cessation
Relapse
Craving
habitual behavior
cognitive remediation
implicit priming
pavlovian instrumental transfer
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in imbalance between goal-directed and habitual behavior
timeFrame: 2 time points: before and after 6 weeks SCP
measure: Change in implicit smoking-related associations
timeFrame: 3 time points: before and after 6 weeks SCP plus after 3 months
measure: Change in attentional bias to smoking cues
timeFrame: 3 time points: before and after 6 weeks SCP plus after 3 months
measure: Change in smoking urges
timeFrame: 3 time points: before and after 6 weeks SCP plus after 3 months
measure: Change in working memory capacity
timeFrame: 3 time points: before and after 6 weeks SCP plus after 3 months
measure: Change in planning ability
timeFrame: 3 time points: before and after 6 weeks SCP plus after 3 months
measure: Change in cognitive flexibility
timeFrame: 3 time points: before and after 6 weeks SCP plus after 3 months
Secondary outcomes:
measure: nicotine consumption
timeFrame: 3 months follow-up
measure: Change in neural PIT effect
timeFrame: 2 time points: before and after 6 weeks SCP
measure: Change in neural cue reactivity
timeFrame: 2 time points: before and after 6 weeks SCP
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
state: Baden-Württemberg
Study officials:
affiliation: Central Institute of Mental Health, Mannheim
name: Sabine Vollstädt-Klein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Institute of Mental Health, Mannheim
name: Herta Flor, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: