Marijuana SmokingSCRIPTNCT06120855
Study on Regulated Cannabis Sales in Pharmacies
A study testing Regulated cannabis from authorized pharmacies and Cannabis from the illicit market in people with Marijuana Smoking and Cannabis, run by University of Bern at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Marijuana Smoking, Cannabis, Cannabis Use
- What is being tested?
- Regulated cannabis from authorized pharmacies and Cannabis from the illicit market
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,177 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 11 Mar 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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 locations and contacts
2 sites in 1 country.
Switzerland2 sites
University of Bern
Bern, 3012
Zentrum für Hausarztmedizin und Community Care, University of Lucerne
Lucerne
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Marijuana Smoking, Cannabis, Cannabis Use
- Being tested
- Regulated cannabis from authorized pharmacies, Cannabis from the illicit market
- Keywords
- Cannabis, Cannabis Use, Cannabis sativa, Cannabinoids
- Medical subject headings
- Marijuana Smoking, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulated cannabis from authorized pharmaciesDrug
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).
Cannabis from the illicit marketDrug
The control group receives no intervention and is expected to continue purchasing cannabis from the illicit market.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Cannabis from the illicit market |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Based on interviews by phone or online
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 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
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Concentration of toxicants in urine
Measured in urine from a sub-sample
Measured: 6 months
Type of cannabis sold per participant in pharmacies
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Amount of cannabis sold per participant in pharmacies
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Self-reported cannabis purchase on the illicit market
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Self-reported frequency of use
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Concentration of THC and CBD in cannabis bought on the illicit market
Measured in cannabis from a random sub-sample.
Measured: 6 months
Concentration of contaminants in cannabis bought on the illicit market
Measured in cannabis from a random sub-sample.
Measured: 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)
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults
Recorded as participant-reported outcome. Measured by Adult ADHD Self-Report Scale (ASRS) questionnaire.
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 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)
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Number of psychotic symptoms
Recorded as participant-reported outcome. Measured by the Psychotic Symptoms (PS) Checklist
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Somatic health
Recorded as participant-reported outcome. Measured by Pittsburgh Sleep Quality Index (PSQ-I) questionnaire.
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 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).
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Severity of dyspnea
Recorded as participant-reported outcome. Measured by Modified Medical Research Council (MMRC) scale for dyspnea.
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
COPD exacerbation assessment
Recorded as participant-reported outcome.
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Quality of life (health-related)
Recorded as participant-reported outcome. Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire.
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Perception of stress
Recorded as participant-reported outcome. Measured by the Perceived Stress Scale (PSS).
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Cannabis use and purchase behavior
Recorded as participant-reported outcome.
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Cannabis use disorder
Recorded as participant-reported outcome. Measured by Cannabis Use Disorders Identification Test - Revised (CUDIT-R) questionnaire.
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Consumption motives
Recorded as participant-reported outcome.
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Consumption competence
Recorded as participant-reported outcome.
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Consumption risk perception
Recorded as participant-reported outcome.
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Nicotine/tobacco use behavior
Recorded as participant-reported outcome
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Exposure to second-hand smoke
Recorded as participant-reported outcome
Measured: 6, 12, 18, 24, 30, 36, 42 & 48 months
Alcohol consumption behavior
Recorded as participant-reported outcome. Measured by Alcohol Use Disorders Identification Test (AUDIT-C).
Measured: 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).
Measured: 6, 12, 18, & 24 months
Medication use behavior
Recorded as participant-reported outcome
Measured: 6, 12, 18, & 24 months
Treatment/Counseling Experience
Recorded as participant-reported outcome
Measured: 6, 12, 18, & 24 months
Use of health and social services
Recorded as participant-reported outcome.
Measured: 6, 12, 18, & 24 months
Body mass index
Cardiovascular risk factor (CVRF) measured at physical examinations.
Measured: 6 months
Blood pressure
Cardiovascular risk factor (CVRF) measured at physical examinations.
Measured: 6 months
Waist-to-hip ratio
Cardiovascular risk factor (CVRF) measured at physical examinations.
Measured: 6 months
Number of safety events
Recorded as participant-reported outcome.
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start11 Mar 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Luzern
- Responsible party
- Sponsor
- Investigators
- Reto Auer, Prof., Study chair, Institute of Primary Health Care (BIHAM), Faculty of Medicine, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120855
- Sponsor's protocol ID
- SCRIPT
- Acronym
- SCRIPT
- Status last verified
- May 2026
- First submitted
- 19 Oct 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safer Cannabis - Research In Pharmacies Randomized Controlled Trial (SCRIPT)
- ClinicalTrials.gov ID
- NCT06120855
- Acronym / sponsor ID
- SCRIPT / SCRIPT
- Conditions
- Marijuana Smoking, Cannabis, Cannabis Use
- Keywords
- Cannabis, Cannabis Use, Cannabis sativa, Cannabinoids
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,177 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Universität Luzern
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Regulated cannabis from authorized pharmacies (intervention group) | Experimental | Drug: Regulated cannabis from authorized pharmaciesMultimodal intervention of authorized, regulated cannabis sale in combination with counselling on reducing harms for recreational cannabis users in Swiss pharmacies (intervention group). |
| Cannabis from the illicit market (control group) | Active comparator | Drug: Cannabis from the illicit marketThe control group receives no intervention and is expected to continue purchasing cannabis from the illicit market. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regulated cannabis from authorized pharmaciesThe 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). | Drug | Regulated cannabis from authorized pharmacies (intervention group) |
| Cannabis from the illicit marketThe control group receives no intervention and is expected to continue purchasing cannabis from the illicit market. | Drug | Cannabis from the illicit market (control group) |
Primary outcome
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
Time frame: 6 months
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.
37 secondary outcomes
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.
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Shift from smoking to safer, alternative delivery methods of cannabis and, if applicable, tobacco.
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Concentration of toxicants in urine
Time frame: 6 months
Type of cannabis sold per participant in pharmacies
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Amount of cannabis sold per participant in pharmacies
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Self-reported cannabis purchase on the illicit market
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Self-reported frequency of use
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Concentration of THC and CBD in cannabis bought on the illicit market
Time frame: 6 months
Concentration of contaminants in cannabis bought on the illicit market
Time frame: 6 months
Severity of generalised anxiety disorder
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Severity of depression
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Number of psychotic symptoms
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Somatic health
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Impact of COPD
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Severity of dyspnea
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
COPD exacerbation assessment
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Quality of life (health-related)
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Perception of stress
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Cannabis use and purchase behavior
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Cannabis use disorder
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Consumption motives
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Consumption competence
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Consumption risk perception
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Nicotine/tobacco use behavior
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Exposure to second-hand smoke
Time frame: 6, 12, 18, 24, 30, 36, 42 & 48 months
Alcohol consumption behavior
Time frame: 6, 12, 18, & 24 months
Drug consumption behavior
Time frame: 6, 12, 18, & 24 months
Medication use behavior
Time frame: 6, 12, 18, & 24 months
Treatment/Counseling Experience
Time frame: 6, 12, 18, & 24 months
Use of health and social services
Time frame: 6, 12, 18, & 24 months
Body mass index
Time frame: 6 months
Blood pressure
Time frame: 6 months
Waist-to-hip ratio
Time frame: 6 months
Number of safety events
Time frame: 6, 12, 18, & 24 months
Inflammation-related protein biomarkers
Time frame: 6 months
Blood biomarker for alcohol and cannabis exposure
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reto Auer, Prof. study chair
Institute of Primary Health Care (BIHAM), Faculty of Medicine, University of Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulated cannabis from authorized pharmacies and Cannabis from the illicit market in people with Marijuana Smoking and Cannabis, run by University of Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.