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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
448

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Responsible Marijuana Vendor Training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klein Buendel, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pacific Institute for Research and Evaluation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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