An interventional study of Policy and Training Intervention and Usual and Customary Policy and Training (UC-PT) (Control) Condition in Alcoholic Intoxication, Automobile Accident and Cannabis, sponsored by Klein Buendel, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Klein Buendel, Inc. · Not applicable, Interventional, and Prevention
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Among 63 studies in Alcoholic Intoxication with a site in United States — 14 open to participants now, 18 under way, 1 of them phase 3. Alcoholic Intoxication · United States.
Among the 63 studies in Alcoholic Intoxication with a site in United States, this one is the 17th largest by planned enrollment of the 55 interventional ones that give a count, is one of 11 that started in 2024, is one of 35 with no phase, reaches primary completion later than 7 of the 17 other live ones, and was the 48th registered.
76 studies on the registry are indexed under Alcoholic Intoxication; 17 are open to participants now.
Browse Alcoholic Intoxication studies →14 of the 63 studies in Alcoholic Intoxication with a site in United States are open now. Recruiting first, the newest first:
University of Pennsylvania · Sites in United States
Ages 21–50 · Healthy volunteers
University of Illinois at Urbana-Champaign · Sites in United States
Ages 21–30 · Healthy volunteers
University of Colorado, Denver · Sites in United States
Ages 21–65 · Healthy volunteers
Carnegie Mellon University · Sites in United States
Ages 21–30 · Healthy volunteers
Yale University · Sites in United States
Ages 18–60 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 10 Alcoholic Intoxication studies recruiting now, 3 (30%) set no upper age limit and 7 (70%) stop at 75 or younger; 1 takes children under 18; 7 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
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63 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 7 · Phase 3 3 · Phase 4 1
First in 1997; this study’s year is marked. 11 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 229 is above the median of 135 across 62 interventional studies indexed under Alcoholic Intoxication.
Median enrollment 153 across the 55 interventional studies, 170 across the 8 observational. Of the 44 that completed or were terminated, 19 (43%) have results posted.
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7 of 63 have an industry lead sponsor. The 10 most frequent:
Klein Buendel, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
Klein Buendel, Inc. has 3 studies filed under Alcoholic Intoxication — fewer than ten, so there is no comparison to draw.
5 of the studies in Alcoholic Intoxication with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03242161Mclean HospitalDevelopment of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations | 2026-12-11 |
| NCT07125534University of Illinois at Urbana-ChampaignAlcohol and the Social Brain: An Alcohol-Administration Hyperscanning Study Employing a Within-Subject Design | 2027-01 |
| NCT06235632Klein Buendel, Inc.Responsible Marijuana Sales Practices to Reduce the Risk of Selling to Intoxicated Customers | 2027-07-01 |
| NCT06293040Johns Hopkins UniversityVaporized Cannabis Administration and Co-Administration of Alcohol on Impairment | 2027-08 |
| NCT07602270University of PennsylvaniaEffects of Ketogenic Diet on Alcohol Intoxication | 2027-08-31 |
Add all 5 to your calendar (.ics) → With an account.
Among the 63 studies in Alcoholic Intoxication with a site in United States, from their registry updates:
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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
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.
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Recreational Marijuana Stores:
Store personnel:
Alcohol Establishments
Exclusion Criteria:
Recreational Marijuana Stores:
Store Personnel:
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
Behavioral: Policy and Training 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
Behavioral: Usual and Customary Policy and Training (UC-PT) (Control) Condition
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
The active control training that is already provided to marijuana vendors by the Oregon Liquor and Cannabis Commission
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
Time frame: Establishments will be evaluated by PiP assessments 4 times (including baseline) over 5 years
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
Time frame: Alcohol establishments will be evaluated by PiP assessments 1 time during Year 1
Started Jan 2024 (actual). Primary completion is estimated for Jul 2027, 41 months after the start.
Of 29 interventional studies with no phase under Alcoholic Intoxication, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 58. This study's planned 41 months is close to that.
How these figures are worked out, and which studies are left out of them.
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