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NCT05522205 Clinical Trial

Regulated Cannabis Access in Basel

Mental Health Disorder Clinical Trial

Official title:
WEED CARE - Randomized Controlled Study on Regulated Cannabis Access for Recreational Use in Pharmacies in Basel

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05522205
Other study ID # 2021-01670
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 31, 2023
Est. completion date July 31, 2025

Study information
Verified date September 2023
Source Health Department of the Canton of Basel-Stadt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 374
Est. completion date July 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Regulated cannabis access in pharmacies
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.

Locations
Country Name City State
Switzerland Canton Basel-Stadt Basel Basel-Stadt

Sponsors (4)
Lead Sponsor Collaborator
Health Department of the Canton of Basel-Stadt Psychiatric Services Aargau AG, University of Basel, University Psychiatric Clinics Basel

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in problematic cannabis consumption behaviour Cannabis Use Disorder Identification Test - Revised; min. value 0, max. value 32; higher scores mean worse outcome 6 / 12 /18 /24 / 30 months
Secondary Change in depression Patient Health Questionnaire; min. value 0, max. value 27; higher scores mean worse outcome 6 / 12 /18 /24 / 30 months
Secondary Change in anxiety Generalized Anxiety Disorder; min. value 0, max. value 21; higher scores mean worse outcome 6 / 12 /18 /24 / 30months
Secondary Change in psychosis Checklist of early intervention; min. value 0, max. value 8; higher scores mean worse outcome 6 / 12 /18 /24 / 30 months
Secondary Change in physical health Symptom Checklist - 90, Somatization; min. value 0, max. value 48; higher scores mean worse outcome 6 / 12 /18 /24 / 30 months
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