NCT05522205

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
374

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

2.5 years

First QC Date

August 8, 2022

Last Update Submit

October 1, 2024

Conditions

Cannabis Use DisorderMental Health DisorderPhysical Illness

Keywords

cannabis regulationhealth effectscannabis consumption

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in depression

    6 / 12 /18 /24 / 30 months

  • Change in anxiety

    6 / 12 /18 /24 / 30months

  • Change in psychosis

    6 / 12 /18 /24 / 30 months

  • Change in physical health

    6 / 12 /18 /24 / 30 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Immediately regulated cannabis access in pharmacies.

Other: Regulated cannabis access in pharmacies

Control group

NO INTERVENTION

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.

Interventions

Regulated cannabis access in pharmaciesOTHER

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years, residence in Basel-Stadt, consuming cannabis at least monthly during the last 6 months (positive urine sample)

You may not qualify if:

  • pregnant or breastfeeding, currently suicidal, currently psychotic, current inpatient psychiatric treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canton Basel-Stadt

Basel, Canton of Basel-City, Switzerland

Location

Related Publications (1)

  • Baltes-Flueckiger L, Steinauer R, Meyer M, Vogel M, Walter M. Effects of cannabis regulation in Switzerland: Study protocol of a randomized controlled trial. Front Psychiatry. 2023 Mar 23;14:1139325. doi: 10.3389/fpsyt.2023.1139325. eCollection 2023.

    PMID: 37032954DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Pharmacies

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 30, 2022

Study Start

January 31, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

October 2, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in publications.

Shared Documents
SAP, ICF
Time Frame
6 months after publication
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.

Locations

CH(1)