Clinical trial NCT06120855: Study on Regulated Cannabis Sales in Pharmacies
Official title: The Safer Cannabis - Research In Pharmacies Randomized Controlled Trial (SCRIPT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Marijuana Smoking
Cannabis
Cannabis Use
Keywords: Cannabis
Cannabis Use
Cannabis sativa
Cannabinoids
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Universität Luzern
First posted: 2023-11-07
Enrollment: 1091
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 design changes to a cohort-study.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 12, 18, & 24 months
measure: Shift from smoking to safer, alternative delivery methods of cannabis and, if applicable, tobacco.
timeFrame: 6, 12, 18, & 24 months
measure: Concentration of toxicants in urine
timeFrame: 6 months
measure: Type of cannabis sold per participant in pharmacies
timeFrame: 6, 12, 18, & 24 months
measure: Amount of cannabis sold per participant in pharmacies
timeFrame: 6, 12, 18, & 24 months
measure: Self-reported cannabis purchase on the illicit market
timeFrame: 6, 12, 18, & 24 months
measure: Self-reported frequency of use
timeFrame: 6, 12, 18, & 24 months
measure: Concentration of THC and CBD in cannabis bought on the illicit market
timeFrame: 6 months
measure: Concentration of contaminants in cannabis bought on the illicit market
timeFrame: 6 months
measure: Severity of generalised anxiety disorder
timeFrame: 6, 12, 18, & 24 months
measure: Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults
timeFrame: 6, 12, 18, & 24 months
measure: Severity of depression
timeFrame: 6, 12, 18, & 24 months
measure: Number of psychotic symptoms
timeFrame: 6, 12, 18, & 24 months
measure: Somatic health
timeFrame: 6, 12, 18, & 24 months
measure: Impact of COPD
timeFrame: 6, 12, 18, & 24 months
measure: Severity of dyspnea
timeFrame: 6, 12, 18, & 24 months
measure: COPD exacerbation assessment
timeFrame: 6, 12, 18, & 24 months
measure: Quality of life (health-related)
timeFrame: 6, 12, 18, & 24 months
measure: Perception of stress
timeFrame: 6, 12, 18, & 24 months
measure: Cannabis use and purchase behavior
timeFrame: 6, 12, 18, & 24 months
measure: Cannabis use disorder
timeFrame: 6, 12, 18, & 24 months
measure: Consumption motives
timeFrame: 6, 12, 18, & 24 months
measure: Consumption competence
timeFrame: 6, 12, 18, & 24 months
measure: Consumption risk perception
timeFrame: 6, 12, 18, & 24 months
measure: Nicotine/tobacco use behavior
timeFrame: 6, 12, 18, & 24 months
measure: Exposure to second-hand smoke
timeFrame: 6, 12, 18, & 24 months
measure: Alcohol consumption behavior
timeFrame: 6, 12, 18, & 24 months
measure: Drug consumption behavior
timeFrame: 6, 12, 18, & 24 months
measure: Medication use behavior
timeFrame: 6, 12, 18, & 24 months
measure: Treatment/Counseling Experience
timeFrame: 6, 12, 18, & 24 months
measure: Use of health and social services
timeFrame: 6, 12, 18, & 24 months
measure: Body mass index
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Waist-to-hip ratio
timeFrame: 6 months
measure: Number of safety events
timeFrame: 6, 12, 18, & 24 months
measure: Inflammation-related protein biomarkers
timeFrame: 6 months
measure: Blood biomarker for alcohol and cannabis exposure
timeFrame: 6 months
Other outcomes:
measure: Gene activity related to chronic cannabis use
timeFrame: Baseline
Locations:
city: Bern
country: Switzerland
facility: University of Bern
city: Lucerne
country: Switzerland
facility: Zentrum für Hausarztmedizin und Community Care, University of Lucerne
Study officials:
affiliation: Institute of Primary Health Care (BIHAM), Faculty of Medicine, University of Bern
name: Reto Auer, Prof.
role: STUDY_CHAIR
References: