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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,091
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).
The control group receives no intervention and is expected to continue purchasing cannabis from the illicit market.
University of Bern
Bern, Switzerland
Zentrum für Hausarztmedizin und Community Care, University of Lucerne
Lucerne, Switzerland
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.
Time frame: 6 months
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
Time frame: 12, 18, & 24 months
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
Time frame: 6, 12, 18, & 24 months
Concentration of toxicants in urine
Measured in urine from a sub-sample
Time frame: 6 months
Type of cannabis sold per participant in pharmacies
Time frame: 6, 12, 18, & 24 months
Amount of cannabis sold per participant in pharmacies
Time frame: 6, 12, 18, & 24 months
Self-reported cannabis purchase on the illicit market
Time frame: 6, 12, 18, & 24 months
Self-reported frequency of use
Time frame: 6, 12, 18, & 24 months
Concentration of THC and CBD in cannabis bought on the illicit market
Measured in cannabis from a random sub-sample.
Time frame: 6 months
Concentration of contaminants in cannabis bought on the illicit market
Measured in cannabis from a random sub-sample.
Time frame: 6 months
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)
Time frame: 6, 12, 18, & 24 months
Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults
Recorded as participant-reported outcome. Measured by Adult ADHD Self-Report Scale (ASRS) questionnaire.
Time frame: 6, 12, 18, & 24 months
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)
Time frame: 6, 12, 18, & 24 months
Number of psychotic symptoms
Recorded as participant-reported outcome. Measured by the Psychotic Symptoms (PS) Checklist
Time frame: 6, 12, 18, & 24 months
Somatic health
Recorded as participant-reported outcome. Measured by Pittsburgh Sleep Quality Index (PSQ-I) questionnaire.
Time frame: 6, 12, 18, & 24 months
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).
Time frame: 6, 12, 18, & 24 months
Severity of dyspnea
Recorded as participant-reported outcome. Measured by Modified Medical Research Council (MMRC) scale for dyspnea.
Time frame: 6, 12, 18, & 24 months
COPD exacerbation assessment
Recorded as participant-reported outcome.
Time frame: 6, 12, 18, & 24 months
Quality of life (health-related)
Recorded as participant-reported outcome. Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire.
Time frame: 6, 12, 18, & 24 months
Perception of stress
Recorded as participant-reported outcome. Measured by the Perceived Stress Scale (PSS).
Time frame: 6, 12, 18, & 24 months
Cannabis use and purchase behavior
Recorded as participant-reported outcome.
Time frame: 6, 12, 18, & 24 months
Cannabis use disorder
Recorded as participant-reported outcome. Measured by Cannabis Use Disorders Identification Test - Revised (CUDIT-R) questionnaire.
Time frame: 6, 12, 18, & 24 months
Consumption motives
Recorded as participant-reported outcome.
Time frame: 6, 12, 18, & 24 months
Consumption competence
Recorded as participant-reported outcome.
Time frame: 6, 12, 18, & 24 months
Consumption risk perception
Recorded as participant-reported outcome.
Time frame: 6, 12, 18, & 24 months
Nicotine/tobacco use behavior
Recorded as participant-reported outcome
Time frame: 6, 12, 18, & 24 months
Exposure to second-hand smoke
Recorded as participant-reported outcome
Time frame: 6, 12, 18, & 24 months
Alcohol consumption behavior
Recorded as participant-reported outcome. Measured by Alcohol Use Disorders Identification Test (AUDIT-C).
Time frame: 6, 12, 18, & 24 months
Drug consumption behavior
Recorded as participant-reported outcome. Measured by Alcohol, Smoking and Substance Involvement Screening Test (ASSIST V3.0).
Time frame: 6, 12, 18, & 24 months
Medication use behavior
Recorded as participant-reported outcome
Time frame: 6, 12, 18, & 24 months
Treatment/Counseling Experience
Recorded as participant-reported outcome
Time frame: 6, 12, 18, & 24 months
Use of health and social services
Recorded as participant-reported outcome.
Time frame: 6, 12, 18, & 24 months
Body mass index
Cardiovascular risk factor (CVRF) measured at physical examinations.
Time frame: 6 months
Blood pressure
Cardiovascular risk factor (CVRF) measured at physical examinations.
Time frame: 6 months
Waist-to-hip ratio
Cardiovascular risk factor (CVRF) measured at physical examinations.
Time frame: 6 months
Number of safety events
Recorded as participant-reported outcome.
Time frame: 6, 12, 18, & 24 months
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.
Time frame: 6 months
Blood biomarker for alcohol and cannabis exposure
Validation of the self-reported exposure to alcohol and cannabis through biomarkers of exposure, measured from blood samples from a sub-sample
Time frame: 6 months
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