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Modification of Goal-directed and Habitual Behavior in Addiction

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
standard smoking cessation program (SCP)
Cognitive remediation treatment (CRT)
Implicit computer-based habit-modifying training (ICHT)
Sponsored by
Central Institute of Mental Health, Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Addiction, Nicotine, Smoking Cessation, Relapse, Craving, habitual behavior, cognitive remediation, implicit priming, pavlovian instrumental transfer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

standard smoking cessation program (SCP)

SCP + CRT

SCP + ICHT

Arm Description

standard smoking cessation program

SCP plus cognitive remediation treatment (CRT)

SCP plus an implicit computer-based habit-modifying training (ICHT)

Outcomes

Primary Outcome Measures

Change in imbalance between goal-directed and habitual behavior
measured by reward devaluation procedure (Hogarth & Chase 2011)
Change in implicit smoking-related associations
smoking-related implicit association task (Wiers et al. 2016).
Change in attentional bias to smoking cues
smoking-related dot-probe task (Vollstädt-Klein et al. 2009).
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
Change in working memory capacity
Spatial Working Memory task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Change in planning ability
One Touch Stockings of Cambridge task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Change in cognitive flexibility
Internal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)

Secondary Outcome Measures

nicotine consumption
self-report
Change in neural PIT effect
PIT phase of a choice task (adapted from Hogarth & Chase 2011)
Change in neural cue reactivity
fMRI cue-reactivity task (Vollstädt-Klein et al. 2011)

Full Information

First Posted
November 28, 2018
Last Updated
October 4, 2023
Sponsor
Central Institute of Mental Health, Mannheim
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1. Study Identification

Unique Protocol Identification Number
NCT03764969
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
June 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Institute of Mental Health, Mannheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Addiction, Nicotine, Smoking Cessation, Relapse, Craving, habitual behavior, cognitive remediation, implicit priming, pavlovian instrumental transfer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard smoking cessation program (SCP)
Arm Type
Active Comparator
Arm Description
standard smoking cessation program
Arm Title
SCP + CRT
Arm Type
Experimental
Arm Description
SCP plus cognitive remediation treatment (CRT)
Arm Title
SCP + ICHT
Arm Type
Experimental
Arm Description
SCP plus an implicit computer-based habit-modifying training (ICHT)
Intervention Type
Behavioral
Intervention Name(s)
standard smoking cessation program (SCP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation treatment (CRT)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Implicit computer-based habit-modifying training (ICHT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in imbalance between goal-directed and habitual behavior
Description
measured by reward devaluation procedure (Hogarth & Chase 2011)
Time Frame
2 time points: before and after 6 weeks SCP
Title
Change in implicit smoking-related associations
Description
smoking-related implicit association task (Wiers et al. 2016).
Time Frame
3 time points: before and after 6 weeks SCP plus after 3 months
Title
Change in attentional bias to smoking cues
Description
smoking-related dot-probe task (Vollstädt-Klein et al. 2009).
Time Frame
3 time points: before and after 6 weeks SCP plus after 3 months
Title
Change in smoking urges
Description
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
Time Frame
3 time points: before and after 6 weeks SCP plus after 3 months
Title
Change in working memory capacity
Description
Spatial Working Memory task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Time Frame
3 time points: before and after 6 weeks SCP plus after 3 months
Title
Change in planning ability
Description
One Touch Stockings of Cambridge task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Time Frame
3 time points: before and after 6 weeks SCP plus after 3 months
Title
Change in cognitive flexibility
Description
Internal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
Time Frame
3 time points: before and after 6 weeks SCP plus after 3 months
Secondary Outcome Measure Information:
Title
nicotine consumption
Description
self-report
Time Frame
3 months follow-up
Title
Change in neural PIT effect
Description
PIT phase of a choice task (adapted from Hogarth & Chase 2011)
Time Frame
2 time points: before and after 6 weeks SCP
Title
Change in neural cue reactivity
Description
fMRI cue-reactivity task (Vollstädt-Klein et al. 2011)
Time Frame
2 time points: before and after 6 weeks SCP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Vollstädt-Klein, Prof. Dr.
Organizational Affiliation
Central Institute of Mental Health, Mannheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Herta Flor, Prof. Dr.
Organizational Affiliation
Central Institute of Mental Health, Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68159
Country
Germany

12. IPD Sharing Statement

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Modification of Goal-directed and Habitual Behavior in Addiction

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