INTERVENTIONALACTIVE NOT RECRUITINGNCT06120855

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

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-05-11

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: NA
Enrollment: 1,177 (ACTUAL)
Start date: 2024-03-11
Sponsor: University of Bern
Design: RANDOMIZED · PARALLEL · OTHER
Locations: 2
Results record: Not present in registry snapshot

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.

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Regulated cannabis from authorized pharmacies

Cannabis from the illicit market

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

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

secondary measures

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

other measures

Gene activity related to chronic cannabis use

Locally readable linked articles