Back to resultsRegulated Cannabis Access in Basel
Primary Purpose
Cannabis Use Disorder, Mental Health Disorder, Physical Illness
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Regulated cannabis access in pharmacies
Sponsored by
About this trial
This is an interventional other trial for Cannabis Use Disorder focused on measuring cannabis regulation, health effects, cannabis consumption
Eligibility Criteria
Inclusion Criteria:
- At least 18 years, residence in Basel-Stadt, consuming cannabis at least monthly during the last 6 months (positive urine sample)
Exclusion Criteria:
- pregnant or breastfeeding, currently suicidal, currently psychotic, current inpatient psychiatric treatment
Sites / Locations
- Canton Basel-Stadt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Immediately regulated cannabis access in pharmacies.
During the first six months participants of the control group have to continue to buy their cannabis on the illicit market. Afterthese six months they also have access to regulated cannabis access.
Outcomes
Primary Outcome Measures
Change in problematic cannabis consumption behaviour
Cannabis Use Disorder Identification Test - Revised; min. value 0, max. value 32; higher scores mean worse outcome
Secondary Outcome Measures
Change in depression
Patient Health Questionnaire; min. value 0, max. value 27; higher scores mean worse outcome
Change in anxiety
Generalized Anxiety Disorder; min. value 0, max. value 21; higher scores mean worse outcome
Change in psychosis
Checklist of early intervention; min. value 0, max. value 8; higher scores mean worse outcome
Change in physical health
Symptom Checklist - 90, Somatization; min. value 0, max. value 48; higher scores mean worse outcome
Full Information
NCT ID
NCT05522205
First Posted
August 8, 2022
Last Updated
September 22, 2023
Sponsor
Health Department of the Canton of Basel-Stadt
Collaborators
University of Basel, University Psychiatric Clinics Basel, Psychiatric Services Aargau AG
1. Study Identification
Unique Protocol Identification Number
NCT05522205
Brief Title
Regulated Cannabis Access in Basel
Official Title
WEED CARE - Randomized Controlled Study on Regulated Cannabis Access for Recreational Use in Pharmacies in Basel
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Department of the Canton of Basel-Stadt
Collaborators
University of Basel, University Psychiatric Clinics Basel, Psychiatric Services Aargau AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The randomised controlled study on regulated cannabis access in pharmacies in Basel aims to investigate the effects of regulated cannabis access on consumption behaviour and mental and physical health in comparison to the illegal market.
Detailed Description
This project consist of two parts: The first part is a randomised controlled study, the second part is an observational study. The randomised controlled study will last six months. Participants will randomly be assigned to one of two groups: Group 1 has immediately access to regulated cannabis in pharmacies; Group 2 has to wait for six months. After six months all participants will have access to regulated cannabis in pharmacies (oberservational study). Every six month participants will be invited to answer online-questionnaires on their cannabis consumption behavior, their mental and physical health. The entire study lasts 2.5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder, Mental Health Disorder, Physical Illness
Keywords
cannabis regulation, health effects, cannabis consumption
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
One group has immediately access to regulated cannabis access in pharmacies and the other group has to wait six months until they have regulated cannabis access.
Allocation
Randomized
Enrollment
374 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Immediately regulated cannabis access in pharmacies.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
During the first six months participants of the control group have to continue to buy their cannabis on the illicit market. Afterthese six months they also have access to regulated cannabis access.
Intervention Type
Other
Intervention Name(s)
Regulated cannabis access in pharmacies
Intervention Description
The study does not investigate the health effects of cannabis. The study investigates the effects of regulated cannabis access on cannabis consumption and health in comparison to the unregulated illegal market.
Primary Outcome Measure Information:
Title
Change in problematic cannabis consumption behaviour
Description
Cannabis Use Disorder Identification Test - Revised; min. value 0, max. value 32; higher scores mean worse outcome
Time Frame
6 / 12 /18 /24 / 30 months
Secondary Outcome Measure Information:
Title
Change in depression
Description
Patient Health Questionnaire; min. value 0, max. value 27; higher scores mean worse outcome
Time Frame
6 / 12 /18 /24 / 30 months
Title
Change in anxiety
Description
Generalized Anxiety Disorder; min. value 0, max. value 21; higher scores mean worse outcome
Time Frame
6 / 12 /18 /24 / 30months
Title
Change in psychosis
Description
Checklist of early intervention; min. value 0, max. value 8; higher scores mean worse outcome
Time Frame
6 / 12 /18 /24 / 30 months
Title
Change in physical health
Description
Symptom Checklist - 90, Somatization; min. value 0, max. value 48; higher scores mean worse outcome
Time Frame
6 / 12 /18 /24 / 30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 18 years, residence in Basel-Stadt, consuming cannabis at least monthly during the last 6 months (positive urine sample)
Exclusion Criteria:
pregnant or breastfeeding, currently suicidal, currently psychotic, current inpatient psychiatric treatment
Facility Information:
Facility Name
Canton Basel-Stadt
City
Basel
State/Province
Basel-Stadt
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in publications.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Only research institutions will have access. Data dictionaries will be shared for studies that are planning to investigate similar research questions. Principal investigator or co-investigator will review the requests.
Learn more about this trial
Regulated Cannabis Access in Basel
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