Alcoholic IntoxicationNCT06235632
Responsible Marijuana Sales Practices to Reduce the Risk of Selling to Intoxicated Customers
A study testing Policy and Training Intervention in people with Alcoholic Intoxication and Automobile Accident, run by Klein Buendel, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcoholic Intoxication, Automobile Accident, Cannabis
- What is being tested?
- Policy and Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Alcoholic Intoxication, Automobile Accident, Cannabis
- Being tested
- Policy and Training Intervention, Usual and Customary Policy and Training (UC-PT) (Control) Condition
- Keywords
- randomized partial cross-over trial, Responsible Marijuana Vendor training
- Medical subject headings
- Alcoholic Intoxication, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Policy and Training InterventionBehavioural
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
Usual and Customary Policy and Training (UC-PT) (Control) ConditionBehavioural
The active control training that is already provided to marijuana vendors by the Oregon Liquor and Cannabis Commission
| Study group | Role | What they receive |
|---|---|---|
| Policy and Training Intervention | Experimental | 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 Receives: Behavioral: Policy and Training Intervention |
| Usual and Customary Policy and Training (UC-PT) (Control) Condition | Active comparator | 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 Receives: Behavioral: Usual and Customary Policy and Training (UC-PT) (Control) Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refusal Rate of Sales of Marijuana to Obviously-intoxicated Customers
The rate at which establishments refuse to sell to obviously-intoxicated customers will be obtained via a pseudo-intoxicated patron (PiP) assessment
Measured: Establishments will be evaluated by PiP assessments 4 times (including baseline) over 5 years
Secondary outcomes (1)
Refusal Rate of Sales of Alcohol to Obviously-intoxicated Customers
The rate at which establishments refuse to sell to obviously-intoxicated customers will be obtained via a pseudo-intoxicated patron (PiP) assessment
Measured: Alcohol establishments will be evaluated by PiP assessments 1 time during Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start15 Jan 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a pretest-posttest randomized control partial cross-over trial. A subsample of stores will be randomly assigned to receive the intervention while the rest will receive the control training. After the posttest assessment is conducted, the remaining control stores will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 229 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Pacific Institute for Research and Evaluation, National Opinion Research Center
- Responsible party
- Sponsor
- Investigators
- Gill Woodall, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235632
- Sponsor's protocol ID
- 0347
- Other IDs
- 1R01AA031591-01A1
- Status last verified
- Dec 2025
- First submitted
- 23 Jan 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Policy and Training Intervention in Responsible Marijuana Sales Practices to Reduce the Risk of Selling to Intoxicated Customers
- ClinicalTrials.gov ID
- NCT06235632
- Acronym / sponsor ID
- 0347
- Conditions
- Alcoholic Intoxication, Automobile Accident, Cannabis
- Keywords
- randomized partial cross-over trial, Responsible Marijuana Vendor training
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 229 participants (estimated)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Pacific Institute for Research and Evaluation, National Opinion Research Center
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pretest-posttest randomized control partial cross-over trial. A subsample of stores will be randomly assigned to receive the intervention while the rest will receive the control training. After the posttest assessment is conducted, the remaining control stores will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Policy and Training Intervention | Experimental | Behavioral: Policy and Training InterventionThis 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 |
| Usual and Customary Policy and Training (UC-PT) (Control) Condition | Active comparator | Behavioral: Usual and Customary Policy and Training (UC-PT) (Control) ConditionThis 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 may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Recreational Marijuana Stores:
- Store personnel:
- Alcohol Establishments
Key exclusion criteria (6 listed)
- Recreational Marijuana Stores:
- Store Personnel:
- Alcohol Establishments • Have an inactive, suspended, or revoked liquor license
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Policy and Training InterventionThe 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 | Behavioural | Policy and Training Intervention |
| Usual and Customary Policy and Training (UC-PT) (Control) ConditionThe active control training that is already provided to marijuana vendors by the Oregon Liquor and Cannabis Commission | Behavioural | Usual and Customary Policy and Training (UC-PT) (Control) Condition |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gill Woodall, PhD principal investigator
Klein Buendel, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Policy and Training Intervention in people with Alcoholic Intoxication and Automobile Accident, run by Klein Buendel, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.