Regulated Cannabis Access in Basel

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cannabis Use Disorder, Mental Health Disorder, Physical Illness

Intervention / Treatment
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* Other: Regulated cannabis access in pharmacies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Immediately regulated cannabis access in pharmacies. | Other: Regulated cannabis access in pharmacies<br>* 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.<br>|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health effects, cannabis regulation, cannabis consumption