- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06235632
Responsible Marijuana Sales Practices to Reduce the Risk of Selling to Intoxicated Customers
December 4, 2025 updated by: Klein Buendel, Inc.
Policy and Training Intervention in Responsible Marijuana Sales Practices to Reduce the Risk of Selling to Intoxicated Customers
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
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
The new recreational marijuana markets are contributing to morbidity and mortality due to marijuana- and polysubstance-impaired driving and other harms by selling a social intoxicant (i.e., marijuana) to already intoxicated customers.
Impairment increases when marijuana is combined with alcohol, making driving particularly risky and also contributing to other injuries and violence.
In recreational marijuana markets, deterrence efforts to reduce impaired driving directed at drivers face challenges due to dispute over THC levels in per se laws and lack of valid field sobriety tests.
An alternative prevention approach is to decrease access to marijuana by alcohol-impaired customers.
The goal of this research is to test the effectiveness of a policy and training (PT) intervention in the state-licensed recreational marijuana market in Oregon, where state law bans sales to obviously-intoxicated customers.
It combines policy efforts by state regulators to increase deterrence of Oregon's law and motivate store management to comply and training of store personnel in skills to recognize intoxication and refuse sales, using a responsible marijuana vendor online training developed by the research team.
The specific aims of the project are to: 1) conduct pseudo-intoxicated patron (PiP) assessments at state-licensed recreational marijuana stores (n=213) in the greater Portland metropolitan area (i.e., Clackamas, Multnomah, and Washington Counties) in Year 1; 2) implement a PT intervention in Year 2 designed to increase compliance with Oregon law prohibiting sale of recreational marijuana products to obviously-intoxicated customers with a subsample of stores (n=68), assigned at random, that intends to a) make owners/managers of recreational marijuana stores aware of Oregon's law prohibiting sales of marijuana to obviously-intoxicated customers, b) increase their risk perception and motivation to comply with this law, and c) train store personnel in skills needed to recognize signs of intoxication in customers and refuse sales; 3) compare PT intervention stores to usual and customary policy and training (UC-PT) stores (n=145) in a randomized controlled trial by posttesting state-licensed recreational marijuana stores in greater Portland with PiP assessments for refusal of sales in Year 3; and 4) estimate impact of the PT intervention on refusal to PiPs by implementing the PT intervention with the remaining stores in Portland in Year 3 in a partial cross-over design and assessing state-licensed stores in greater Portland with the PiP protocol in Year 4 and in Year 5.
The research is innovative and high impact by testing one of the first interventions to prevent recreational marijuana sales to obviously-intoxicated customers in one of the first states to ban such sales to reduce the risk of poly-substance impaired driving and other harms.
The design allows for reproducibility by using a partial cross-over to enhance power with both between- and within-group comparisons.
The PT intervention can be a model intervention to improve compliance with regulations on recreational marijuana sales in other states that have legalized recreational marijuana, now numbering 17 U.S. states, or that are considering legalization.
Study Type
Interventional
Enrollment (Estimated)
229
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
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Recreational Marijuana Stores:
- Located in the greater Portland, Oregon metropolitan area or Salem, Oregon metro area
- Hold an active recreational marijuana license from the Oregon Liquor Control Commission (OLCC) as of July 1, 2022
- A retail store that sells recreational marijuana products
- Store is open for business
- Have a smart phone, tablet computer, or personal computer with Internet access
- Owner or manager consent for store to participate
Store personnel:
- Own or employed at a state-licensed recreational marijuana store in greater Portland, Oregon or Salem, Oregon metro area
- Sell recreational marijuana products in a retail store
- Aged 21 or older (by state law)
- Able to read English
- Have a smart phone, tablet computer, or personal computer with Internet access
- Consent to participate
Alcohol Establishments
- Located in the greater Portland, Oregon or Salem metropolitan area
- Hold an active liquor license from the Oregon Liquor Control Commission (OLCC) as of July 1, 2022
- An establishment that sells alcohol for on-site or off-site consumption
- Store is open for business
Exclusion Criteria:
Recreational Marijuana Stores:
- Have an inactive, suspended, or revoked recreational marijuana license
- Licensed to sell only medical marijuana
Store Personnel:
• Cannot read English
- Alcohol Establishments • Have an inactive, suspended, or revoked liquor license
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Policy and Training 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
|
The intervention is a combination of a policy training and access to an in-depth training program to teach marijuana vendors the skills needed to refuse intoxicated customers
|
|
Active Comparator: Usual and Customary Policy and Training (UC-PT) (Control) Condition
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
|
The active control training that is already provided to marijuana vendors by the Oregon Liquor and Cannabis Commission
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Refusal Rate of Sales of Marijuana to Obviously-intoxicated Customers
Time Frame: Establishments will be evaluated by PiP assessments 4 times (including baseline) over 5 years
|
The rate at which establishments refuse to sell to obviously-intoxicated customers will be obtained via a pseudo-intoxicated patron (PiP) assessment
|
Establishments will be evaluated by PiP assessments 4 times (including baseline) over 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Refusal Rate of Sales of Alcohol to Obviously-intoxicated Customers
Time Frame: Alcohol establishments will be evaluated by PiP assessments 1 time during Year 1
|
The rate at which establishments refuse to sell to obviously-intoxicated customers will be obtained via a pseudo-intoxicated patron (PiP) assessment
|
Alcohol establishments will be evaluated by PiP assessments 1 time during Year 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gill Woodall, PhD, Klein Buendel, Inc.
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 (Actual)
January 15, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
August 31, 2027
Study Registration Dates
First Submitted
January 23, 2024
First Submitted That Met QC Criteria
January 23, 2024
First Posted (Actual)
February 1, 2024
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0347 (Ohio State University Medical Center)
- 1R01AA031591-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cannabis
-
Anders Fink-Jensen, MD, DMSciNeurobiology Research Unit, RigshospitaletRecruitingCannabis Dependence | Cannabis Abuse | Cannabis Use Disorder | Cannabis Use Disorders | Cannabis AddictionDenmark
-
University of MinnesotaNot yet recruitingCannabis Use | Cannabis Use DisorderUnited States
-
Centre hospitalier de l'Université de Montréal...CompletedCannabis | Cannabis Dependence | Cannabis Use | Cannabis Smoking | Cannabis Use, UnspecifiedCanada
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)RecruitingMarijuana Abuse | Marijuana Use | Addiction | Substance Use | Cannabis Dependence | Substance Use Disorders | Cannabis Use | Substance Abuse | Addiction, Substance | Marijuana Dependence | Substance Dependence | Marijuana Smoking | Cannabis Abuse | Cannabis Use Disorder | Marijuana | Cannabis Intoxication | Substance Related... and other conditionsUnited States
-
Elias DakwarActive, not recruitingAddiction | Cannabis Dependence | Cannabis Use | Substance Abuse | Cannabis Abuse | Cannabis Use DisorderUnited States
-
Boston Children's HospitalNational Institute on Drug Abuse (NIDA)RecruitingCannabis Use | Cannabis Use Disorder | Cannabis IntoxicationUnited States
-
Yale UniversityRobert E. Leet and Clara Guthrie Patterson Trust Mentored Research AwardCompletedCannabis | Cannabis Use | Cannabis AbuseUnited States
-
Brown UniversityNational Institute on Drug Abuse (NIDA)CompletedCannabis Dependence | Cannabis AbuseUnited States
-
University of WashingtonNational Institute on Drug Abuse (NIDA)CompletedCannabis Dependence | Cannabis Abuse
-
PleoPharma, Inc.RecruitingCannabis WithdrawalUnited States
Clinical Trials on Policy and Training Intervention
-
Penn State UniversityLondon School of Hygiene and Tropical Medicine; William T. Grant Foundation; Child... and other collaboratorsCompletedChild Abuse | Family and Household | Legislation | PolicyUnited States, United Kingdom
-
University of British ColumbiaRecruitingPatient ReadmissionCanada
-
Wayne State UniversityUniversity of New Mexico; Loyola University Chicago; LifeStance HealthCompletedSubstance Use Disorders | Mental Disorder | Social StigmaUnited States
-
Shanghai Stroke Service SystemChanghai Hospital; Shanghai Zhongshan Hospital; RenJi Hospital; Huashan Hospital; Ruijin Hospital and other collaboratorsUnknown
-
National Institute of Environmental Health Sciences...Completed
-
Forman Christian College, PakistanUNICEFRecruitingMaternal Health | Maternal Health LiteracyPakistan
-
Noha Mohamed SharafeldinO'Neal Comprehensive Cancer Center at UABRecruitingMultiple MyelomaUnited States
-
UNC Lineberger Comprehensive Cancer CenterCompleted
-
Harvard School of Public Health (HSPH)Centers for Disease Control and PreventionCompletedChild Nutrition | Child Physical ActivityUnited States