Modification of Goal-directed and Habitual Behavior in Addiction

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764969
• Other study ID #: TRR265 C01
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: June 23, 2023

Study information

• Verified date: October 2023
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Tobacco Use Disorder

Intervention

Behavioral:
• 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.
• 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).
• 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.

Locations

Country	Name	City	State
Germany	Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit	Mannheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	nicotine consumption	self-report	3 months follow-up
Secondary	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
Secondary	Change in neural cue reactivity	fMRI cue-reactivity task (Vollstädt-Klein et al. 2011)	2 time points: before and after 6 weeks SCP