Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT03764969
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2018-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modification of Goal-directed and Habitual Behavior in Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2018-11-28', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in imbalance between goal-directed and habitual behavior', 'timeFrame': '2 time points: before and after 6 weeks SCP', 'description': 'measured by reward devaluation procedure (Hogarth \\& Chase 2011)'}, {'measure': 'Change in implicit smoking-related associations', 'timeFrame': '3 time points: before and after 6 weeks SCP plus after 3 months', 'description': 'smoking-related implicit association task (Wiers et al. 2016).'}, {'measure': 'Change in attentional bias to smoking cues', 'timeFrame': '3 time points: before and after 6 weeks SCP plus after 3 months', 'description': 'smoking-related dot-probe task (Vollstädt-Klein et al. 2009).'}, {'measure': 'Change in smoking urges', 'timeFrame': '3 time points: before and after 6 weeks SCP plus after 3 months', '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'}, {'measure': 'Change in working memory capacity', 'timeFrame': '3 time points: before and after 6 weeks SCP plus after 3 months', 'description': 'Spatial Working Memory task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)'}, {'measure': 'Change in planning ability', 'timeFrame': '3 time points: before and after 6 weeks SCP plus after 3 months', 'description': 'One Touch Stockings of Cambridge task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)'}, {'measure': 'Change in cognitive flexibility', 'timeFrame': '3 time points: before and after 6 weeks SCP plus after 3 months', 'description': 'Internal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)'}], 'secondaryOutcomes': [{'measure': 'nicotine consumption', 'timeFrame': '3 months follow-up', 'description': 'self-report'}, {'measure': 'Change in neural PIT effect', 'timeFrame': '2 time points: before and after 6 weeks SCP', 'description': 'PIT phase of a choice task (adapted from Hogarth \\& Chase 2011)'}, {'measure': 'Change in neural cue reactivity', 'timeFrame': '2 time points: before and after 6 weeks SCP', 'description': 'fMRI cue-reactivity task (Vollstädt-Klein et al. 2011)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Addiction', 'Nicotine', 'Smoking Cessation', 'Relapse', 'Craving', 'habitual behavior', 'cognitive remediation', 'implicit priming', 'pavlovian instrumental transfer'], 'conditions': ['Tobacco Use Disorder']}, 'referencesModule': {'references': [{'pmid': '36698210', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe tobacco use disorder (TUD) according to DSM-5\n* sufficient ability to communicate with investigators and answer questions in both written and verbal format\n* ability to provide fully informed consent and to use self-rating scales\n\nExclusion Criteria:\n\n* 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\n* history of brain injury\n* severe physical diseases\n* common exclusion criteria for MRI (e.g. metal, claustrophobia)\n* positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)\n* psychotropic medication within the last 14 days\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03764969', 'briefTitle': 'Modification of Goal-directed and Habitual Behavior in Addiction', 'organization': {'class': 'OTHER', 'fullName': 'Central Institute of Mental Health, Mannheim'}, 'officialTitle': 'Modification of the Imbalance Between Goal-directed and Habitual Behavior in Human Addiction', 'orgStudyIdInfo': {'id': 'TRR265 C01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard smoking cessation program (SCP)', 'description': 'standard smoking cessation program', 'interventionNames': ['Behavioral: standard smoking cessation program (SCP)']}, {'type': 'EXPERIMENTAL', 'label': 'SCP + CRT', 'description': 'SCP plus cognitive remediation treatment (CRT)', 'interventionNames': ['Behavioral: standard smoking cessation program (SCP)', 'Behavioral: Cognitive remediation treatment (CRT)']}, {'type': 'EXPERIMENTAL', 'label': 'SCP + ICHT', 'description': 'SCP plus an implicit computer-based habit-modifying training (ICHT)', 'interventionNames': ['Behavioral: standard smoking cessation program (SCP)', 'Behavioral: Implicit computer-based habit-modifying training (ICHT)']}], 'interventions': [{'name': 'standard smoking cessation program (SCP)', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['SCP + CRT', 'SCP + ICHT', 'standard smoking cessation program (SCP)']}, {'name': 'Cognitive remediation treatment (CRT)', 'type': 'BEHAVIORAL', '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).', 'armGroupLabels': ['SCP + CRT']}, {'name': 'Implicit computer-based habit-modifying training (ICHT)', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['SCP + ICHT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68159', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Sabine Vollstädt-Klein, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Institute of Mental Health, Mannheim'}, {'name': 'Herta Flor, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Institute of Mental Health, Mannheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Institute of Mental Health, Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}