CannabisNCT03073291
Intervening to Prevent Youth Access to Marijuana Phase II
A study testing Responsible Marijuana Vendor Training in people with Cannabis, run by Klein Buendel, Inc. at 2 sites in United States.
Trial summary
The legalization of recreational marijuana use and sales in Alaska, Colorado, Oregon, and Washington State is a dramatic change in U.S. substance abuse policy that places a priority on developing regulatory and enforcement systems that prevent distribution of retail recreational marijuana to minors. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- Responsible Marijuana Vendor Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being 21 or older,
- owning a retail marijuana outlet or being employed as a manager or budtender at a retail marijuana outlet,
- have a smart phone, tablet computer or personal computer with Internet access, and
- consenting to participate
Who cannot join
- a family or household member is already participating,
- they are not proficient in English, or
- they participated in the SBIR Phase I research
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Klein Buendel, Inc.
Golden, Colorado, 80401
Pacific Institute for Research and Evaluation
Oakland, California, 94612
About this study
The legalization of recreational marijuana use and sales in Alaska, Colorado, Oregon, and Washington State is a dramatic change in U.S. substance abuse policy that places a priority on developing regulatory and enforcement systems that prevent distribution of retail recreational marijuana to minors. Responsible marijuana vendor training, modeled after effective responsible alcoholic beverage training, has the potential to help the states prevent distribution to minors. This research will produce a responsible marijuana vendor training provided by a third party, not the cannabis industry, and test its effectiveness with retail recreational marijuana licensees and employees in Colorado, Oregon, and Washington State.
Read the detailed description
The legalization of recreational marijuana in Alaska, Colorado, Oregon, and Washington State is the most dramatic change in U.S. substance abuse policy since the end of Prohibition. These states are implementing regulatory and enforcement systems for the retail sales of recreational marijuana to adults 21 years or older, akin to state controls on the sale of alcohol. In 2013, the U.S. Department of Justice (DOJ) issued directives that it would monitor whether these states implemented strong and effective regulatory and enforcement systems that among other DOJ priorities, prevented distribution of marijuana to youth. A retail sales intervention that has been effective at reducing illegal alcohol sales to minors (and intoxicated patrons) is alcoholic beverage server training (or responsible beverage service training). Recently, Colorado enacted a law for incentivized responsible marijuana vendor training, Oregon will require responsible marijuana vendor training, and Washington State may incentivize it. In this study, we propose to 1) produce the TrainToTend online responsible marijuana vendor training presenting retail marijuana sales laws, methods for checking IDs and preventing third party sales, the health effects of marijuana (e.g., fetal exposure; safe storage), customer service (e.g., driving under the influence; refusing sales to minors), and rules of the trade (e.g., inventory tracking and safety procedures) and 2) conduct a randomized trial on the TrainToTend training with a sample of retail recreational marijuana stores in Colorado, Oregon and Washington State (n=150) that are randomly assigned to have their employees complete the TrainToTend training (experimental group) or receive usual and customary sales training by store managers (no intervention control group). The effect of the TrainToTend training on responsible sales practices will be assessed by changes in recreational marijuana purchase attempts by pseudo-underage patrons (i.e., young-appearing customers without apparently valid IDs) at each store measured at 3-month follow-up and 9-month follow-up relative to baseline.
- Conditions
- Cannabis
- Being tested
- Responsible Marijuana Vendor Training
- Keywords
- cannabis, commerce
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Responsible Marijuana Vendor TrainingBehavioural
Employees at retail recreational marijuana stores assigned to the the responsible marijuana vendor training will register them on TrainToTend online training program, create a user profile, and complete the training within four weeks from initial registration. Personnel who complete the training will receive a certificate of completion. New hires at the stores during the trial will be registered and complete the training within four weeks of commencing work. Separate versions of the training will be available reflecting differences in the laws/regulations on recreational marijuana sales in Colorado, Oregon, and Washington State and the content will be reviewed and approved by state regulators.
| Study group | Role | What they receive |
|---|---|---|
| Responsible Marijuana Vendor Training | Experimental | The TrainToTend online responsible marijuana vendor training teaches responsible sales practices in five modules: Module 1, The Laws; Module 2, ID Checking; Module 3, Health Effects; Module 4, Customer Service, and Module 5, Rules of the Trade. The training content will be conveyed using online educational activities providing application and feedback such as in tabs with appropriate graphics and interactive simulations where users apply the skill and receive informative/corrective feedback. Receives: Behavioral: Responsible Marijuana Vendor Training |
| Usual and Customary Sales Practices Training | No intervention | Usual and customary training in retail sales practices delivered to employees at retail recreational marijuana stores by store managers. Some retail stores in Colorado may receive responsible marijuana vendor training of some type from another state-approved training provider. Thus, we consider the outlets in the control group to have usual and customer sales training but not to be entirely untrained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pseudo-underage Buyer Purchase Attempts
Successful purchase attempts of a recreational marijuana product by underage-appearing pseudo-patron buyer will be assessed by pseudo-patron teams of a buyer and observer. The observer will enter the retail recreational marijuana store, showing a valid ID indicating they are 21 or older. The buyer will attempt to enter the store. If asked for an ID, the buyer will say they do not have a driver's license (acceptable form of ID) and offer instead a college ID (unacceptable form of ID). If permitted to enter store, buyer will ask to purchase pre-rolled joints. When the clerk asks the buyer to make payment, the buyer will say they do not have enough money and leave the store. The observer and buyer will record the outcome of the purchase attempt. No actual recreational marijuana product will be purchased.
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Secondary outcomes (1)
Change in State-required Store Signage
Observers in the pseudo-patron teams will record the presence of signage in the stores required by state regulations.
Measured: Baseline, 3-month follow-up, and 9-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startJun 2016
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CannabisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pacific Institute for Research and Evaluation
- Responsible party
- Sponsor
- Investigators
- David Buller, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073291
- Sponsor's protocol ID
- 2R44DA038933-02
- Other IDs
- 0309
- Status last verified
- Jun 2019
- First submitted
- 3 Mar 2017
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: At the conclusion of the project Klein Buendel Inc. will initiate a data sharing plan to make data from this project publicly available via archive files and publish reports describing study procedures in detail in peer-reviewed academic journals. Public data sets will be de-identified so that they are free of all identifiers that would permit linkages to individual research participants and of variables that could lead to deductive disclosure of the identity of individual participants. Individuals wishing to use this data will be required to fill out the KB Data Sharing Request Form, which asks for information on the type of data being requested, anticipated data use, research questions, study design, variables, analysis plan, and IRB approval.
Publications
Buller DB, Woodall WG, Saltz R, Grayson A, Buller MK, Cutter GR, Svendsen S, Liu X. Randomized Trial Testing an Online Responsible Vendor Training in Recreational Marijuana Stores in the United States. J Stud Alcohol Drugs. 2021 Mar;82(2):204-213. doi: 10.15288/jsad.2021.82.204.
PubMed 33823967Buller DB, Woodall WG, Saltz R, Grayson A, Svendsen S, Cutter GR. Sales to apparently alcohol-intoxicated customers and online responsible vendor training in recreational cannabis stores in a randomized trial. Int J Drug Policy. 2020 Sep;83:102860. doi: 10.1016/j.drugpo.2020.102860. Epub 2020 Jul 21.
PubMed 32707476
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening to Prevent Youth Access to Marijuana Phase II
- ClinicalTrials.gov ID
- NCT03073291
- Acronym / sponsor ID
- 2R44DA038933-02
- Conditions
- Cannabis
- Keywords
- cannabis, commerce
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pacific Institute for Research and Evaluation
- Study start
- Jun 2016
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 8 Mar 2017 (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.
The legalization of recreational marijuana use and sales in Alaska, Colorado, Oregon, and Washington State is a dramatic change in U.S. substance abuse policy that places a priority on developing regulatory and enforcement systems that prevent distribution of retail recreational marijuana to minors. Responsible marijuana vendor training, modeled after effective responsible alcoholic beverage training, has the potential to help the states prevent distribution to minors. This research will produce a responsible marijuana vendor training provided by a third party, not the cannabis industry, and test its effectiveness with retail recreational marijuana licensees and employees in Colorado, Oregon, and Washington State.
Detailed description
The legalization of recreational marijuana in Alaska, Colorado, Oregon, and Washington State is the most dramatic change in U.S. substance abuse policy since the end of Prohibition. These states are implementing regulatory and enforcement systems for the retail sales of recreational marijuana to adults 21 years or older, akin to state controls on the sale of alcohol. In 2013, the U.S. Department of Justice (DOJ) issued directives that it would monitor whether these states implemented strong and effective regulatory and enforcement systems that among other DOJ priorities, prevented distribution of marijuana to youth. A retail sales intervention that has been effective at reducing illegal alcohol sales to minors (and intoxicated patrons) is alcoholic beverage server training (or responsible beverage service training). Recently, Colorado enacted a law for incentivized responsible marijuana vendor training, Oregon will require responsible marijuana vendor training, and Washington State may incentivize it. In this study, we propose to 1) produce the TrainToTend online responsible marijuana vendor training presenting retail marijuana sales laws, methods for checking IDs and preventing third party sales, the health effects of marijuana (e.g., fetal exposure; safe storage), customer service (e.g., driving under the influence; refusing sales to minors), and rules of the trade (e.g., inventory tracking and safety procedures) and 2) conduct a randomized trial on the TrainToTend training with a sample of retail recreational marijuana stores in Colorado, Oregon and Washington State (n=150) that are randomly assigned to have their employees complete the TrainToTend training (experimental group) or receive usual and customary sales training by store managers (no intervention control group). The effect of the TrainToTend training on responsible sales practices will be assessed by changes in recreational marijuana purchase attempts by pseudo-underage patrons (i.e., young-appearing customers without apparently valid IDs) at each store measured at 3-month follow-up and 9-month follow-up relative to baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responsible Marijuana Vendor Training | Experimental | Behavioral: Responsible Marijuana Vendor TrainingThe TrainToTend online responsible marijuana vendor training teaches responsible sales practices in five modules: Module 1, The Laws; Module 2, ID Checking; Module 3, Health Effects; Module 4, Customer Service, and Module 5, Rules of the Trade. The training content will be conveyed using online educational activities providing application and feedback such as in tabs with appropriate graphics and interactive simulations where users apply the skill and receive informative/corrective feedback. |
| Usual and Customary Sales Practices Training | No intervention | –Usual and customary training in retail sales practices delivered to employees at retail recreational marijuana stores by store managers. Some retail stores in Colorado may receive responsible marijuana vendor training of some type from another state-approved training provider. Thus, we consider the outlets in the control group to have usual and customer sales training but not to be entirely untrained. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being 21 or older,
- owning a retail marijuana outlet or being employed as a manager or budtender at a retail marijuana outlet,
- have a smart phone, tablet computer or personal computer with Internet access, and
- consenting to participate
Key exclusion criteria (3 listed)
- a family or household member is already participating,
- they are not proficient in English, or
- they participated in the SBIR Phase I research
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 |
|---|---|---|
| Responsible Marijuana Vendor TrainingEmployees at retail recreational marijuana stores assigned to the the responsible marijuana vendor training will register them on TrainToTend online training program, create a user profile, and complete the training within four weeks from initial registration. Personnel who complete the training will receive a certificate of completion. New hires at the stores during the trial will be registered and complete the training within four weeks of commencing work. Separate versions of the training will be available reflecting differences in the laws/regulations on recreational marijuana sales in Colorado, Oregon, and Washington State and the content will be reviewed and approved by state regulators. | Behavioural | Responsible Marijuana Vendor Training |
Primary outcome
Change in Pseudo-underage Buyer Purchase Attempts
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
Successful purchase attempts of a recreational marijuana product by underage-appearing pseudo-patron buyer will be assessed by pseudo-patron teams of a buyer and observer. The observer will enter the retail recreational marijuana store, showing a valid ID indicating they are 21 or older. The buyer will attempt to enter the store. If asked for an ID, the buyer will say they do not have a driver's license (acceptable form of ID) and offer instead a college ID (unacceptable form of ID). If permitted to enter store, buyer will ask to purchase pre-rolled joints. When the clerk asks the buyer to make payment, the buyer will say they do not have enough money and leave the store. The observer and buyer will record the outcome of the purchase attempt. No actual recreational marijuana product will be purchased.
1 secondary outcome
Change in State-required Store Signage
Time frame: Baseline, 3-month follow-up, and 9-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Derived from this study: PubMed 33823967Buller DB, Woodall WG, Saltz R, Grayson A, Buller MK, Cutter GR, Svendsen S, Liu X. Randomized Trial Testing an Online Responsible Vendor Training in Recreational Marijuana Stores in the United States. J Stud Alcohol Drugs. 2021 Mar;82(2):204-213. doi: 10.15288/jsad.2021.82.204.
- Derived from this study: PubMed 32707476Buller DB, Woodall WG, Saltz R, Grayson A, Svendsen S, Cutter GR. Sales to apparently alcohol-intoxicated customers and online responsible vendor training in recreational cannabis stores in a randomized trial. Int J Drug Policy. 2020 Sep;83:102860. doi: 10.1016/j.drugpo.2020.102860. Epub 2020 Jul 21.
- Individual participant dataSharing planned: No. At the conclusion of the project Klein Buendel Inc. will initiate a data sharing plan to make data from this project publicly available via archive files and publish reports describing study procedures in detail in peer-reviewed academic journals. Public data sets will be de-identified so that they are free of all identifiers that would permit linkages to individual research participants and of variables that could lead to deductive disclosure of the identity of individual participants. Individuals wishing to use this data will be required to fill out the KB Data Sharing Request Form, which asks for information on the type of data being requested, anticipated data use, research questions, study design, variables, analysis plan, and IRB approval.
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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.
David Buller, PhD principal investigator
Klein Buendel, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Responsible Marijuana Vendor Training in people with Cannabis, run by Klein Buendel, Inc. at 2 sites in United States.
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 3 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: finished, as of the sponsor's last update on 12 Jun 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Pseudo-underage Buyer Purchase Attempts (time frame: Baseline, 3-month follow-up, and 9-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03073291, which also lists 2 linked publications.
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 12 Jun 2019.