Training for Responsible Cannabis Sales

Overseen By Lila Martinez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Klein Buendel, Inc.

Disqualifiers: Inactive license, Medical marijuana only, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

229 Participants Needed

Trial Summary

What is the purpose of this trial?

The new recreational marijuana markets are contributing to polysubstance-impaired driving and other harms, especially when marijuana is used in combination with alcohol, by selling marijuana to obviously-intoxicated customers. In this study, the effectiveness of an intervention to reduce the risk of marijuana sales to obviously-intoxicated customers will be tested in the state-licensed recreational marijuana market in Oregon, one of the first states to ban such sales. The intervention will combine efforts by state regulators to increase deterrence of the state law prohibiting marijuana sales to obviously-intoxicated customers with training of store personnel to recognize signs of intoxication and refuse sales. It will also include testing the rate at which visibly intoxicated customers are refused alcohol at nearby establishments that sell alcohol either on-site or off-site

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the training for responsible cannabis sales safe for humans?

The safety of cannabis and cannabinoid products is still being studied, and there are concerns about adverse effects, especially since clinical experience is limited. Long-term safety monitoring is needed to better understand the risks associated with cannabis use. ^{1 2 3 4 5}

How does the Usual and Customary Policy and Training (UC-PT) treatment differ from other treatments for responsible cannabis sales?

The Usual and Customary Policy and Training (UC-PT) is unique because it focuses on training cannabis vendors in responsible sales practices, similar to interventions used in alcohol markets, to prevent sales to intoxicated customers. This approach is novel in the cannabis industry, where such training is not yet standard. ^{6 7 8 9 10}

Research Team

Gill Woodall, PhD

Principal Investigator

Klein Buendel, Inc.

Eligibility Criteria

This trial is for state-licensed recreational marijuana stores in Oregon. It aims to involve store personnel who will be trained to recognize and refuse sales to visibly intoxicated customers, potentially reducing impaired driving incidents.

Inclusion Criteria

Able to read English

Recreational Marijuana Stores located in the greater Portland, Oregon metropolitan area or Salem, Oregon metro area

This criterion does not apply to clinical trial eligibility.

Exclusion Criteria

Alcohol Establishments have an inactive, suspended, or revoked liquor license

I am licensed to sell medical marijuana only.

Recreational Marijuana Stores have an inactive, suspended, or revoked recreational marijuana license

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Conduct pseudo-intoxicated patron (PiP) assessments at state-licensed recreational marijuana stores

1 year

Intervention

Implement a policy and training intervention to increase compliance with Oregon law prohibiting sales to obviously-intoxicated customers

1 year

Post-Intervention Assessment

Compare intervention stores to control stores using PiP assessments for refusal of sales

1 year

Follow-up

Estimate impact of the intervention on refusal rates by implementing the intervention with remaining stores and assessing with PiP protocol

2 years

Treatment Details

Interventions

• Policy and Training Intervention
• Usual and Customary Policy and Training (UC-PT)

Trial Overview The study tests a new intervention against usual policies. The intervention includes training staff on recognizing intoxication and refusing sales, paired with increased law enforcement deterrence of selling marijuana to intoxicated individuals.

Participant Groups

Group I: Policy and Training Intervention Experimental Treatment 1 Intervention

This intervention includes the combination of a 2-hour policy meeting held by the Oregon Liquor and Cannabis Commission to teach the current laws around selling recreational marijuana as well as access to the TrainToTend program which contains 5 modules: The Laws, ID Checking, Health Effects, Customer Service, and Rules of the Trade

Group II: Usual and Customary Policy and Training (UC-PT) (Control) Condition Active Control 1 Intervention

This is basic Responsible Marijuana Vendor training currently provided by the Oregon Liquor and Cannabis Commission and includes reading a booklet on selling recreational marijuana responsibly and passing and exam

Who Is Running the Clinical Trial?

Klein Buendel, Inc.

Lead Sponsor

Trials

41

Recruited

20,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Pacific Institute for Research and Evaluation

Collaborator

Trials

28

Recruited

34,200+

National Opinion Research Center

Collaborator

Trials

15

Recruited

251,000+

Findings from Research

The safety of cannabis and cannabinoid medications is a significant concern, and while some safety information can be drawn from recreational use studies, medical and recreational users may experience different effects.

There is a pressing need for long-term safety monitoring of cannabinoid use in patients, as clinical experience is still developing, which will help inform both therapeutic decisions and public policy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues concerning the medical use of cannabis and cannabinoids. Ware, MA., Tawfik, VL.[2019]

In a study of 2991 patients over three years, only 3.6% experienced moderate or severe adverse events (AEs) after starting medical cannabis, indicating a relatively low incidence of serious side effects in real-world use.

Common mild AEs included dizziness, nausea, and somnolence, with variations depending on the method of consumption and cannabinoid content, suggesting that healthcare providers should consider these factors when prescribing medical cannabis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry. Hachem, Y., Moride, Y., Castilloux, AM., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Preparation and Distribution of Cannabis and Cannabis-Derived Dosage Formulations for Investigational and Therapeutic Use in the United States. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Safety issues concerning the medical use of cannabis and cannabinoids. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Adverse Reactions Associated With Cannabis Consumption as Evident From Search Engine Queries. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Do We Have Structure, Process and Outcomes to Support Cannabis as Supportive Therapy in Cancer? [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Sales to apparently alcohol-intoxicated customers and online responsible vendor training in recreational cannabis stores in a randomized trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial Testing an Online Responsible Vendor Training in Recreational Marijuana Stores in the United States. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Implementation and Effectiveness of an Online Responsible Vendor Training Program for Recreational Marijuana Stores in Colorado, Oregon, and Washington State. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Barriers to Achieving Optimal Success with Medical Cannabis: Opportunities for Quality Improvement. [2020]

10. Scotland pubmed.ncbi.nlm.nih.gov

Cannabis education needs assessment among Canadian physicians-in-training. [2020]