Study on Regulated Cannabis Sales in Pharmacies

Cannabis Use Clinical Trial

— SCRIPT  

Official title:

The Safer Cannabis - Research In Pharmacies Randomized Controlled Trial (SCRIPT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120855
• Other study ID #: SCRIPT
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2023
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: University of Bern
• Contact: Reto Auer, Prof.
• Phone: +41 31 684 58 79
• Email: reto.auer[@]unibe.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Though regulated cannabis sales are increasing, little is known about the individual health effects of cannabis regulation. Data from countries with a regulated market can be used to test the effect of regulation on the price of cannabis in the illicit market, and to explore its effect on social and health outcomes at the societal level, but strength of evidence for individual health and social outcomes is more limited because it must be aggregated on a state or country level. Data on individual and social outcomes should include baseline measurements before and outcome measurements after regulations changed. In this context, randomized-controlled trials are the least biased source of data on the effects of interventions.

The SCRIPT study aims to investigate the individual health and social impact on recreational cannabis users who are allowed to purchase authorized, regulated cannabis from Swiss pharmacies compared to users who buy cannabis on the illicit market. Participants are randomly allocated in one of the two groups and followed-up for 6 months. After 6 months, all participants are allowed to participate in the intervention and the cohort is followed up for another 18 months.

The intervention includes various offers: Participants can choose between cannabis sorts and delivery methods, and they are encouraged to shift from smoking cannabis to vaping cannabis-containing e-liquids, vaporizing cannabis blossoms or using oral cannabis. Vaping / vaporizing electronic devices are also recommended. At the same time, pharmacists offer opportunistic smoking cessation and problematic cannabis, alcohol use and further drug use counseling that conforms to motivational interviewing principles.

The SCRIPT study adheres to rigorous quality criteria for the production and storage of regulated cannabis products. Only vaping / vaporizing electronic devices which are validated to reduce exposure to toxicants compared to cannabis smoking are recommended.

Description:

Cannabis is the most consumed illegal substance in Switzerland. Many countries and an increasing number of US states have regularized cannabis production and distribution for non-medical use. Analyses of the effects of regulation are promising on a population level, but the causal effects of regulation have only been assessed in before-after studies or ecological comparisons between countries or states. Randomized controlled trials (RCT) are needed to better assess the effects of cannabis regulation on individuals. Since May 2021, the conduct of scientific pilot studies are allowed in Switzerland. While rigorous quality and safety standards cannot be implemented in illicit production and distribution networks, they can be implemented in regulated markets. Beyond psychiatric outcomes, the major hazard associated with cannabis use on somatic health outcomes are mostly related to smoking cannabis and mixing it with tobacco. Regulation therefore also opens the door to harm reduction strategies like counseling users to vape, vaporize, or eat cannabis instead of smoking it. Regulated sale in pharmacies would further facilitate smoking cessation counseling and access to health and social care for those in need. The SCRIPT trial aims to investigate the individual health and social impact on recreational cannabis users who are offered a multimodal intervention of authorized, regulated cannabis sale in combination with counselling on reducing harm (intervention group) compared to users who continue to buy cannabis on the illicit market (control group).

The intervention group is allowed to purchase regulated cannabis in authorized pharmacies. The intervention includes various offers: Participants can choose between cannabis sorts and delivery methods, and they are encouraged to shift from smoking cannabis to vaping cannabis-containing e-liquids, vaporizing cannabis blossoms or using oral cannabis. Vaping / vaporizing electronic devices are also recommended. At the same time, pharmacists offer opportunistic smoking cessation and problematic cannabis, alcohol use and further drug use counseling that conforms to motivational interviewing principles. The control group receives no intervention and is expected to continue purchasing cannabis from the illicit market.

This is a multicenter, pragmatic, open-labelled randomized controlled trial from baseline to 6-months follow-up. After 6 months, the control group is allowed to purchase cannabis in pharmacies, too, and the study designs changes to a cohort-study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1091
• Est. completion date: September 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cannabis
• Cannabis Use
• Marijuana Abuse
• Marijuana Smoking
• Marijuana Use

Intervention

Drug:
• Regulated cannabis from authorized pharmacies
The intervention group is allowed to purchase regulated cannabis in authorized pharmacies. The intervention includes various offers: Participants can choose between cannabis sorts and delivery methods, and they are encouraged to shift from smoking cannabis to vaping cannabis-containing e-liquids, vaporizing cannabis blossoms or using oral cannabis. Vaping / vaporizing electronic devices are also recommended. At the same time, pharmacists offer opportunistic smoking cessation and problematic cannabis, alcohol use and further drug use counseling that conforms to motivational interviewing principles. Study participants can choose between different cannabis-containing products such as dried cannabis flowers, cannabis concentrates (colloquially called hashish or hash), e-liquids and oral cannabis. Besides the cannabis products, participants can buy vaping or vaporizing electronic devices at the pharmacy (they are not considered as study products).
• Cannabis from the illicit market
The control group receives no intervention and is expected to continue purchasing cannabis from the illicit market.

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern
Switzerland	Zentrum für Hausarztmedizin und Community Care, University of Lucerne	Lucerne

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	Universität Luzern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To distinguish between non-smoker and smoker, the cut-off for the CO measurement is <10 parts per million (ppm) and no self-reported combustible cannabis and tobacco use within the last 7 days (7-day point prevalence of abstinence). The validation is based on the worst-case principle. Smokers are considered as; participants with a positive CO measurement, even if the self-report is negative.; participants with a positive self-declaration, even if the CO measurement is negative.	6 months
Secondary	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.	Based on interviews by phone or online	12, 18, & 24 months
Secondary	Shift from smoking to safer, alternative delivery methods of cannabis and, if applicable, tobacco.	Shift from smoking cannabis to safer, alternative delivery methods of cannabis and, if applicable, from smoking tobacco to alternative nicotine delivery systems or nicotine cessation between groups among those who were smoking cannabis at baseline and/or were smoking tobacco at baseline, with and without validation	6, 12, 18, & 24 months
Secondary	Concentration of toxicants in urine	Measured in urine from a sub-sample	6 months
Secondary	Type of cannabis sold per participant in pharmacies		6, 12, 18, & 24 months
Secondary	Amount of cannabis sold per participant in pharmacies		6, 12, 18, & 24 months
Secondary	Self-reported cannabis purchase on the illicit market		6, 12, 18, & 24 months
Secondary	Self-reported frequency of use		6, 12, 18, & 24 months
Secondary	Concentration of THC and CBD in cannabis bought on the illicit market	Measured in cannabis from a random sub-sample.	6 months
Secondary	Concentration of contaminants in cannabis bought on the illicit market	Measured in cannabis from a random sub-sample.	6 months
Secondary	Severity of generalised anxiety disorder	Recorded as participant-reported outcome. Measured by Generalised Anxiety Disorder (GAD-7) questionnaire (scores range from 0 to 21, with higher scores indicating higher levels of generalised anxiety)	6, 12, 18, & 24 months
Secondary	Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults	Recorded as participant-reported outcome. Measured by Adult ADHD Self-Report Scale (ASRS) questionnaire.	6, 12, 18, & 24 months
Secondary	Severity of depression	Recorded as participant-reported outcome. Measured by the Patient Health Questionnaire-9 (PHQ-9) (scores range from 0 to 27, with higher scores indicating more depressive symptoms)	6, 12, 18, & 24 months
Secondary	Number of psychotic symptoms	Recorded as participant-reported outcome. Measured by the Psychotic Symptoms (PS) Checklist	6, 12, 18, & 24 months
Secondary	Somatic health	Recorded as participant-reported outcome. Measured by Pittsburgh Sleep Quality Index (PSQ-I) questionnaire.	6, 12, 18, & 24 months
Secondary	Impact of COPD	Recorded as participant-reported outcome. Measured by COPD Assessment Test (CAT) questionnaire (scores range from 0 to 40, with higher scores indicating indicating a more severe impact of COPD on a patient's life).	6, 12, 18, & 24 months
Secondary	Severity of dyspnea	Recorded as participant-reported outcome. Measured by Modified Medical Research Council (MMRC) scale for dyspnea.	6, 12, 18, & 24 months
Secondary	COPD exacerbation assessment	Recorded as participant-reported outcome.	6, 12, 18, & 24 months
Secondary	Quality of life (health-related)	Recorded as participant-reported outcome. Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire.	6, 12, 18, & 24 months
Secondary	Perception of stress	Recorded as participant-reported outcome. Measured by the Perceived Stress Scale (PSS).	6, 12, 18, & 24 months
Secondary	Cannabis use and purchase behavior	Recorded as participant-reported outcome.	6, 12, 18, & 24 months
Secondary	Cannabis use disorder	Recorded as participant-reported outcome. Measured by Cannabis Use Disorders Identification Test - Revised (CUDIT-R) questionnaire.	6, 12, 18, & 24 months
Secondary	Consumption motives	Recorded as participant-reported outcome.	6, 12, 18, & 24 months
Secondary	Consumption competence	Recorded as participant-reported outcome.	6, 12, 18, & 24 months
Secondary	Consumption risk perception	Recorded as participant-reported outcome.	6, 12, 18, & 24 months
Secondary	Nicotine/tobacco use behavior	Recorded as participant-reported outcome	6, 12, 18, & 24 months
Secondary	Exposure to second-hand smoke	Recorded as participant-reported outcome	6, 12, 18, & 24 months
Secondary	Alcohol consumption behavior	Recorded as participant-reported outcome. Measured by Alcohol Use Disorders Identification Test (AUDIT-C).	6, 12, 18, & 24 months
Secondary	Drug consumption behavior	Recorded as participant-reported outcome. Measured by Alcohol, Smoking and Substance Involvement Screening Test (ASSIST V3.0).	6, 12, 18, & 24 months
Secondary	Medication use behavior	Recorded as participant-reported outcome	6, 12, 18, & 24 months
Secondary	Treatment/Counseling Experience	Recorded as participant-reported outcome	6, 12, 18, & 24 months
Secondary	Use of health and social services	Recorded as participant-reported outcome.	6, 12, 18, & 24 months
Secondary	Body mass index	Cardiovascular risk factor (CVRF) measured at physical examinations.	6 months
Secondary	Blood pressure	Cardiovascular risk factor (CVRF) measured at physical examinations.	6 months
Secondary	Waist-to-hip ratio	Cardiovascular risk factor (CVRF) measured at physical examinations.	6 months
Secondary	Number of safety events	Recorded as participant-reported outcome.	6, 12, 18, & 24 months
Secondary	Inflammation-related protein biomarkers	Measured from blood samples from a sub-sample. Analysis of 92 protein biomarkers associated with inflammatory and immune response processes using the Olink® Target 96 Inflammation Panels.	6 months