A randomized controlled pilot study on the regulated sale of cannabis in pharmacies
Descrizione riassuntiva dello studio
Cannabis is the most commonly consumed illegal substance in Switzerland. The regulation of cannabis sales has been discussed for a long time to curb the black market and its negative aspects. However, current knowledge about the consequences of regulation remains severely limited. Many cannabis consumers smoke cannabis and often also tobacco. Smoking is one of the biggest public health problems and is considered the main risk factor for many diseases. With a combination of regulated distribution and appropriate education about less harmful alternatives to smoking (e.g., E-Joints), this situation could be improved. The main objective of this study is to evaluate how such an offer (regulated cannabis distribution plus education/support for problematic substance use) affects adults who already regularly consume cannabis. Primarily, consumption behavior, especially the switch from smoking to alternative consumption methods, will be evaluated. Additionally, health and social impacts will be analyzed. Participants will be randomly assigned to one of two groups. One group can purchase cannabis products from the beginning in pharmacies, while the other group is only allowed to do so after 6 months. Both groups have regular study visits for data collection.
(BASEC)
Intervento studiato
Participants can purchase cannabis in various forms of consumption at the pharmacy. They are encouraged to switch from smoking to alternative methods such as vaping, vaporizing, or oral intake. At the same time, information about health and cannabis consumption as well as support for quitting smoking and for problematic drug or alcohol use is provided. The study is subject to strict quality criteria for the production and storage of regulated cannabis products.
(BASEC)
Malattie studiate
This study examines individuals who consume cannabis for non-medical purposes in their leisure time.
(BASEC)
- regular cannabis consumption - at least 18 years old - residence in the canton where the study is conducted (BASEC)
Criteri di esclusione
- pregnancy or breastfeeding - prescription to obtain medical cannabis - severe psychosis or suicidal thoughts (BASEC)
Luogo dello studio
Berna, Luzern
(BASEC)
Sponsor
Universität Bern Berner Institut für Hausarztmedizin Abteilung Substanzkonsum
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Reto Auer
031 684 58 79
reto.auer@clutterbiham.unibe.chUniversität Bern Berner Institut für Hausarztmedizin Abteilung Substanzkonsum
(BASEC)
Informazioni generali
Institute of Primary Health Care (BIHAM), Faculty of Medicine, University of Bern,
+41 31 684 58 79
reto.auer@clutterbiham.unibe.ch(ICTRP)
Informazioni scientifiche
Institute of Primary Health Care (BIHAM), Faculty of Medicine, University of Bern,
+41 31 684 58 79
reto.auer@clutterbiham.unibe.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
05.09.2023
(BASEC)
ID di studio ICTRP
NCT06120855 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
The Safer Cannabis – Research In Pharmacies randomized controlled Trial (SCRIPT) (BASEC)
Titolo accademico
The Safer Cannabis - Research In Pharmacies Randomized Controlled Trial (SCRIPT) (ICTRP)
Titolo pubblico
Study on Regulated Cannabis Sales in Pharmacies (ICTRP)
Malattie studiate
Marijuana Smoking;Cannabis;Cannabis Use (ICTRP)
Intervento studiato
Drug: Regulated cannabis from authorized pharmacies;Drug: Cannabis from the illicit market (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- At least 18 years old (validated with valid identification document)
- Written informed consent
- Regular cannabis user: Self-reported cannabis use at least once a month over the
last 6 months and verified cannabis exposure based on urine analysis at baseline
- Resident status in the canton of Bern (for cannabis purchase in the cities of Bern
or Biel) or in the city of Lucerne (for cannabis purchase in the city of Lucerne)
(validated with registration confirmation from the municipality or confirmation of
the residential address)
Exclusion Criteria:
- Pregnant women (pregnancy test based on urine sample)
- Breastfeeding women (self-reported)
- People with a prescription for medical cannabis (self-reported)
- People currently in psychiatric inpatient treatment (self-reported)
- People with current, severe psychosis (self-reported and confirmed by study
nurse/study physician)
- People with current, severe suicidal thoughts (self-reported and confirmed by study
nurse/study physician)
- Inability to follow the procedures of the study due to severe cognitive impairment
or language problems
- People who cannot attend the baseline study visit in-person
- People planning to move out of the canton of residence within 6 months of entering
the trial.
- People who are participating or have participated (inclusion date up to one year
ago) in another cannabis pilot trial which allows to buy regulated cannabis
(validated by matching untraceable codes between studies witch the same catchment
area). (ICTRP)
non disponibile
Endpoint primari e secondari
Self-reported cannabis and tobacco smoking abstinence in the 7 days prior to the 6-months follow-up visit, validated by carbon monoxide (CO) in exhaled air (ICTRP)
Self-reported reported 7-days point prevalence abstinence from cannabis and tobacco smoking at 6 months follow-up, without validation by CO in exhaled air.;Shift from smoking to safer, alternative delivery methods of cannabis and, if applicable, tobacco.;Concentration of toxicants in urine;Type of cannabis sold per participant in pharmacies;Amount of cannabis sold per participant in pharmacies;Self-reported cannabis purchase on the illicit market;Self-reported frequency of use;Concentration of THC and CBD in cannabis bought on the illicit market;Concentration of contaminants in cannabis bought on the illicit market;Severity of generalised anxiety disorder;Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults;Severity of depression;Number of psychotic symptoms;Somatic health;Impact of COPD;Severity of dyspnea;COPD exacerbation assessment;Quality of life (health-related);Perception of stress;Cannabis use and purchase behavior;Cannabis use disorder;Consumption motives;Consumption competence;Consumption risk perception;Nicotine/tobacco use behavior;Exposure to second-hand smoke;Alcohol consumption behavior;Drug consumption behavior;Medication use behavior;Treatment/Counseling Experience;Use of health and social services;Body mass index;Blood pressure;Waist-to-hip ratio;Number of safety events;Inflammation-related protein biomarkers;Blood biomarker for alcohol and cannabis exposure (ICTRP)
Data di registrazione
19.10.2023 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Universit?t Luzern (ICTRP)
Contatti aggiuntivi
Reto Auer, Prof.;Reto Auer, Prof., reto.auer@unibe.ch, +41 31 684 58 79, Institute of Primary Health Care (BIHAM), Faculty of Medicine, University of Bern, (ICTRP)
ID secondari
SCRIPT (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06120855 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile