Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06235632 |
| Other study ID # |
0347 |
| Secondary ID |
1R01AA031591-01A |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 17, 2023 |
| Est. completion date |
September 2028 |
Study information
| Verified date |
January 2024 |
| Source |
Klein Buendel, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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
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.
