Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04989205
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2021-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Community Based Cannabis Cessation Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-24', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-24', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cannabis use', 'timeFrame': 'Changes from baseline to post-treatment and follow-up, on average 5 months', 'description': 'Days with cannabis use last 30 days'}], 'secondaryOutcomes': [{'measure': 'Mental distress', 'timeFrame': 'Changes from baseline to post-treatment and follow-up, on average 5 months', 'description': 'The Hopkins Symptom Checklist (HSCL) 25-item version was used to measure mental distress. Each of the 25 items was scored on a 4-point scale (1-4). An average score was computed, indicating a global severity index of mental distress (GSI), where higher scores indicated greater distress. Clinical cut-off = 1.75'}, {'measure': 'Well-being', 'timeFrame': 'Changes from baseline to post-treatment and follow-up, on average 5 months', 'description': 'The Outcome Rating Scale (ORS) was used to assess well-being. The scale has four visual analogue items on personal, interpersonal, social, and general well-being, and each item are scored from 0 = bad up to 10 = good. The items are then summed (range 0-40) and a score \\<25 indicated scores expected in a clinical population.'}, {'measure': 'Social network', 'timeFrame': 'Changes from baseline to post-treatment and follow-up, on average 5 months', 'description': 'Number of current friends with and without problematic substance use'}, {'measure': 'Sense of Coherence (SoC)', 'timeFrame': 'Changes from baseline to post-treatment and follow-up, on average 5 months', 'description': 'The Sense of Coherence questionnaire, 29 item version, measures the degree to which the subject feels that he or she has a sense of control over their own lives (manageability - 10 items), that life has meaning (8 items) and that their social life is understandable (comprehensibility - 11 items). Responses to items are scored on a seven-point semantic differential scale. Scores are summed (ranges from 29 - 203) and higher scores indicated a stronger SoC'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cannabis Use']}, 'referencesModule': {'references': [{'pmid': '35709178', 'type': 'DERIVED', 'citation': 'Vederhus JK, Rorendal M, Skardal M, Naess MO, Clausen T, Kristensen O. Successful outcomes with low-threshold intervention for cannabis use disorders in Norway - an observational study. PLoS One. 2022 Jun 16;17(6):e0269988. doi: 10.1371/journal.pone.0269988. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The study examined a community based cannabis cessation program in Norway (CCP). The CCP uses a combination of cognitive therapy and psychoeducation and covers the normal withdrawal period for cannabis smoking cessation (up to 8 weeks), comprising \\~15 individual sessions. From 2005 onwards, the CCP was implemented as a low-threshold community-based program in several Norwegian municipalities, e.g., Kristiansand, Fredrikstad and Oslo. The study had an observational one-group pre- / post test design. Outcomes was changes in cannabis use, mental distress, well-being, social network and sense of coherence (SoC) measured post-intervention (T2) and at a 3 months follow-up (T3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target group was individuals who engaged in regular or daily cannabis use, and who were motivated to quit cannabis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severity of Dependence Scale (SDS) score ≥4\n\nExclusion Criteria:\n\n* polydrug use where cannabis was not the predominating substance of use\n* psychiatric comorbidity that was perceived as too severe to handle at the community-based centers'}, 'identificationModule': {'nctId': 'NCT04989205', 'briefTitle': 'Community Based Cannabis Cessation Program', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sorlandet Hospital HF'}, 'officialTitle': 'Examining a Community Based Intervention for Cannabis Smoking Cessation in Norway - an Observational Study', 'orgStudyIdInfo': {'id': '005004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HAP - group', 'description': 'The target group was individuals who engaged in regular or daily cannabis use, and who were motivated to quit cannabis. The formal inclusion criteria was a Severity of Dependence Scale (SDS) score ≥4 and being ≥16 years old. Exclusion criteria was polydrug use where cannabis was not the predominating substance of use and psychiatric comorbidity that was perceived as too severe to handle at the community-based centers .', 'interventionNames': ['Behavioral: Cannabis cessation Program']}], 'interventions': [{'name': 'Cannabis cessation Program', 'type': 'BEHAVIORAL', 'description': "Lundqvist and Ericsson developed the 'Cannabis Cessation Program' (CCP, Nordic abbreviation: HAP) in Sweden in the 1990s. The method uses a combination of cognitive therapy and psychoeducation and covers the normal withdrawal period for cannabis smoking cessation (up to 8 weeks), comprising \\~15 individual sessions. It describes a medical, a psychological, and a social phase, in which the participant is helped to recognize and address typical problems related to each phase, e.g., physical and psychological withdrawal problems. The overarching aim of the program is to help cannabis users to reorganize thinking patterns that developed while they were using cannabis and increase their social and psychological coping skills in relation to quitting cannabis use. The CCP manual has been translated into eight languages, e.g., Norwegian.", 'armGroupLabels': ['HAP - group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fredrikstad', 'country': 'Norway', 'facility': 'Social Services, Fredrikstad Municipality', 'geoPoint': {'lat': 59.2181, 'lon': 10.9298}}, {'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Kristiansand Municipality, Cannabis Cessation Program', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'City Centre Outreach Service, Agency for Social and Welfare Services', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'John-Kåre Vederhus, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Addiction Unit, Sørlandet Hospital, Kristiansand'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Upon request', 'ipdSharing': 'YES', 'description': 'Study protocol will be shared upon request. Anonymous data will be shared upon reasonable request', 'accessCriteria': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'City of Oslo', 'class': 'UNKNOWN'}, {'name': 'Municipality of Kristiansand', 'class': 'UNKNOWN'}, {'name': 'Norway Centre for Addiction Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}