- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04989205
Community Based Cannabis Cessation Program
July 24, 2021 updated by: Sorlandet Hospital HF
Examining a Community Based Intervention for Cannabis Smoking Cessation in Norway - an Observational Study
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
102
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fredrikstad, Norway
- Social Services, Fredrikstad Municipality
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Kristiansand, Norway
- Kristiansand Municipality, Cannabis Cessation Program
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Oslo, Norway
- City Centre Outreach Service, Agency for Social and Welfare Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The target group was individuals who engaged in regular or daily cannabis use, and who were motivated to quit cannabis.
Description
Inclusion Criteria:
- Severity of Dependence Scale (SDS) score ≥4
Exclusion Criteria:
- polydrug use where cannabis was not the predominating substance of use
- psychiatric comorbidity that was perceived as too severe to handle at the community-based centers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HAP - group
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 .
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cannabis use
Time Frame: Changes from baseline to post-treatment and follow-up, on average 5 months
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Days with cannabis use last 30 days
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Changes from baseline to post-treatment and follow-up, on average 5 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental distress
Time Frame: Changes from baseline to post-treatment and follow-up, on average 5 months
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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
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Changes from baseline to post-treatment and follow-up, on average 5 months
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Well-being
Time Frame: Changes from baseline to post-treatment and follow-up, on average 5 months
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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.
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Changes from baseline to post-treatment and follow-up, on average 5 months
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Social network
Time Frame: Changes from baseline to post-treatment and follow-up, on average 5 months
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Number of current friends with and without problematic substance use
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Changes from baseline to post-treatment and follow-up, on average 5 months
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Sense of Coherence (SoC)
Time Frame: Changes from baseline to post-treatment and follow-up, on average 5 months
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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
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Changes from baseline to post-treatment and follow-up, on average 5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John-Kåre Vederhus, PhD, Addiction Unit, Sørlandet Hospital, Kristiansand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 2, 2013
Primary Completion (Actual)
January 31, 2017
Study Completion (Actual)
January 31, 2017
Study Registration Dates
First Submitted
July 12, 2021
First Submitted That Met QC Criteria
July 24, 2021
First Posted (Actual)
August 4, 2021
Study Record Updates
Last Update Posted (Actual)
August 4, 2021
Last Update Submitted That Met QC Criteria
July 24, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 005004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Study protocol will be shared upon request.
Anonymous data will be shared upon reasonable request
IPD Sharing Time Frame
Upon request
IPD Sharing Access Criteria
Upon request
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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