Regulated Cannabis Access in Basel

September 22, 2023 updated by: Marc Walter, Health Department of the Canton of Basel-Stadt

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

374

Phase

  • Not Applicable

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

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland
        • Canton Basel-Stadt

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Immediately regulated cannabis access in pharmacies.
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.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in problematic cannabis consumption behaviour
Time Frame: 6 / 12 /18 /24 / 30 months
Cannabis Use Disorder Identification Test - Revised; min. value 0, max. value 32; higher scores mean worse outcome
6 / 12 /18 /24 / 30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression
Time Frame: 6 / 12 /18 /24 / 30 months
Patient Health Questionnaire; min. value 0, max. value 27; higher scores mean worse outcome
6 / 12 /18 /24 / 30 months
Change in anxiety
Time Frame: 6 / 12 /18 /24 / 30months
Generalized Anxiety Disorder; min. value 0, max. value 21; higher scores mean worse outcome
6 / 12 /18 /24 / 30months
Change in psychosis
Time Frame: 6 / 12 /18 /24 / 30 months
Checklist of early intervention; min. value 0, max. value 8; higher scores mean worse outcome
6 / 12 /18 /24 / 30 months
Change in physical health
Time Frame: 6 / 12 /18 /24 / 30 months
Symptom Checklist - 90, Somatization; min. value 0, max. value 48; higher scores mean worse outcome
6 / 12 /18 /24 / 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Department of the Canton of Basel-Stadt

Collaborators

University of Basel
University Psychiatric Clinics Basel
Psychiatric Services Aargau AG

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)

January 31, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • SAP
  • ICF

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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