Study on Regulated Cannabis Sales in Pharmacies

NCT06120855 | Active Not Recruiting

• 1 other identifier: SCRIPT
• Study Type: interventional
• Target: 1,091
• Locations: 1 country
• Sites: 2

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.

Conditions

Marijuana Smoking; Cannabis; Cannabis Use

Keywords

Cannabis; Cannabis Use; Cannabis sativa; Cannabinoids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (37)

• 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.

  12, 18, & 24 months

• Shift from smoking to safer, alternative delivery methods of cannabis and, if applicable, tobacco.

  6, 12, 18, & 24 months

• Concentration of toxicants in urine

  6 months

• Type of cannabis sold per participant in pharmacies

  6, 12, 18, & 24 months

• Amount of cannabis sold per participant in pharmacies

  6, 12, 18, & 24 months

Other Outcomes (1)

• Gene activity related to chronic cannabis use

  Baseline

Study Arms (2)

Regulated cannabis from authorized pharmacies (intervention group)

EXPERIMENTAL

Multimodal intervention of authorized, regulated cannabis sale in combination with counselling on reducing harms for recreational cannabis users in Swiss pharmacies (intervention group).

Drug: Regulated cannabis from authorized pharmacies

Cannabis from the illicit market (control group)

ACTIVE COMPARATOR

The control group receives no intervention and is expected to continue purchasing cannabis from the illicit market.

Drug: Cannabis from the illicit market

Interventions

Regulated cannabis from authorized pharmacies DRUG

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).

Regulated cannabis from authorized pharmacies (intervention group)

Cannabis from the illicit market DRUG

The control group receives no intervention and is expected to continue purchasing cannabis from the illicit market.

Cannabis from the illicit market (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bern: lead
• Universität Luzern: collaborator

Study Sites (2)

University of Bern

Bern, 3012, Switzerland

Location

Zentrum für Hausarztmedizin und Community Care, University of Lucerne

Lucerne, Switzerland

Location

MeSH Terms

Conditions

Marijuana Smoking; Marijuana Abuse

Condition Hierarchy (Ancestors)

Marijuana Use; Behavior; Smoking, Non-Tobacco Products; Smoking; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Reto Auer, Prof.

  Institute of Primary Health Care (BIHAM), Faculty of Medicine, University of Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 7, 2023
• Study Start: March 11, 2024
• Primary Completion: March 11, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)