Study on Regulated Cannabis Sales in Pharmacies (SCRIPT)

U

University of Bern

Status

Enrolling

Conditions

Cannabis
Cannabis Use
Marijuana Smoking

Treatments

Drug: Cannabis from the illicit market
Drug: Regulated cannabis from authorized pharmacies

Study type

Interventional

Funder types

Other

Identifiers

NCT06120855
SCRIPT

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,091 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,091 participants in 2 patient groups

Regulated cannabis from authorized pharmacies (intervention group)
Experimental group
Description:
Multimodal intervention of authorized, regulated cannabis sale in combination with counselling on reducing harms for recreational cannabis users in Swiss pharmacies (intervention group).
Treatment:
Drug: Regulated cannabis from authorized pharmacies
Cannabis from the illicit market (control group)
Active Comparator group
Description:
The control group receives no intervention and is expected to continue purchasing cannabis from the illicit market.
Treatment:
Drug: Cannabis from the illicit market

Trial contacts and locations

2

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Central trial contact

Reto Auer, Prof.; Kathrin Bieri

Data sourced from clinicaltrials.gov

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