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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04989205
Other study ID # 005004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2, 2013
Est. completion date January 31, 2017

Study information

Verified date July 2021
Source Sorlandet Hospital HF
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date January 31, 2017
Est. primary completion date January 31, 2017
Accepts healthy volunteers
Gender All
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cannabis cessation Program
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.

Locations

Country Name City State
Norway Social Services, Fredrikstad Municipality Fredrikstad
Norway Kristiansand Municipality, Cannabis Cessation Program Kristiansand
Norway City Centre Outreach Service, Agency for Social and Welfare Services Oslo

Sponsors (4)

Lead Sponsor Collaborator
Sorlandet Hospital HF City of Oslo, Municipality of Kristiansand, Norway Centre for Addiction Research

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cannabis use Days with cannabis use last 30 days Changes from baseline to post-treatment and follow-up, on average 5 months
Secondary Mental distress 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 Changes from baseline to post-treatment and follow-up, on average 5 months
Secondary Well-being 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. Changes from baseline to post-treatment and follow-up, on average 5 months
Secondary Social network Number of current friends with and without problematic substance use Changes from baseline to post-treatment and follow-up, on average 5 months
Secondary Sense of Coherence (SoC) 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 Changes from baseline to post-treatment and follow-up, on average 5 months
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