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

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

    • California
      • Oakland, California, United States, 94612
        • Pacific Institute for Research and Evaluation
    • Colorado
      • Golden, Colorado, United States, 80401
        • Klein Buendel, Inc.

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:

  1. being 21 or older,
  2. owning a retail marijuana outlet or being employed as a manager or budtender at a retail marijuana outlet,
  3. have a smart phone, tablet computer or personal computer with Internet access, and
  4. consenting to participate

Exclusion Criteria:

  1. a family or household member is already participating,
  2. they are not proficient in English, or
  3. 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.

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

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
Observers in the pseudo-patron teams will record the presence of signage in the stores required by state regulations.
Baseline, 3-month follow-up, and 9-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

Keywords

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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