- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03073291
Intervening to Prevent Youth Access to Marijuana Phase II
June 11, 2019 updated by: Klein Buendel, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
448
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Oakland, California, United States, 94612
- Pacific Institute for Research and Evaluation
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Colorado
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Golden, Colorado, United States, 80401
- Klein Buendel, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- a family or household member is already participating,
- they are not proficient in English, or
- they participated in the SBIR Phase I research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Responsible Marijuana Vendor Training
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.
|
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.
|
No Intervention: Usual and Customary Sales Practices Training
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 3-month follow-up, and 9-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in State-required Store Signage
Time Frame: Baseline, 3-month follow-up, and 9-month follow-up
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Observers in the pseudo-patron teams will record the presence of signage in the stores required by state regulations.
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Baseline, 3-month follow-up, and 9-month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Buller, PhD, Klein Buendel, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Buller 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.
- Buller DB, Woodall WG, Saltz R, Buller MK. Compliance With Personal ID Regulations by Recreational Marijuana Stores in Two U.S. States. J Stud Alcohol Drugs. 2019 Nov;80(6):679-686.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
March 3, 2017
First Submitted That Met QC Criteria
March 3, 2017
First Posted (Actual)
March 8, 2017
Study Record Updates
Last Update Posted (Actual)
June 12, 2019
Last Update Submitted That Met QC Criteria
June 11, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2R44DA038933-02 (U.S. NIH Grant/Contract)
- 0309 (Klein Buendel, Inc.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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