Substance Use BehaviorNCT07922239
Substance Use and Media Preferences
A study testing Alcohol beverage, Cannabis (smoked flower) and Simultaneous Alcohol and Cannabis in people with Substance Use Behavior and Cannabis Intoxication, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this randomized clinical trial is to learn how alcohol use, cannabis use, and using both substances affect whether and how quickly people stop a video being shown to a woman. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Behavior, Cannabis Intoxication, Alcohol Intoxication
- What is being tested?
- Alcohol beverage, Cannabis (smoked flower) and Simultaneous Alcohol and Cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- May 2027to Mar 2031
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and lifestyle considerations .
- Aged 21-30, verified by a photo ID.
- Consume an alcohol quantity on a single occasion that is equal to or greater than the dose administered in the laboratory on ≥ 3 days in the past year (see Table 1).
- Smoked cannabis ≥ 3 days in the past year.
- Engaging in simultaneous alcohol and cannabis use ≥ 1 day in the past year.
Who cannot join
- Currently being treated or in recovery for alcohol or drug problems; currently interested in seeking treatment for drinking or drug use via self-report.
- Experienced an adverse event while co-using alcohol and cannabis at any time in the past 3 months.
- Any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration as determined by the Study Physician.
- Acute Psychiatric Symptomatology: elevated psychological distress as indicated by a score greater than 65 on the Brief Symptom Inventory.
- Self-report that a participant is trying to get pregnant, currently pregnant, or a positive pregnancy test.
- Combined height and weight that is either less than 6 feet tall and over 230 lbs, or over 250 lbs and over 6 ft tall as measured during the lab visit or by a valid photo ID.
- Current or past participation in PI Leone's research study 'Understanding the Influence of Alcohol and Media on Relationships' protocol #24-1867.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Anschutz Medical Campus
Denver, Colorado, 80045
Ruschelle Leone, PhD, 303-724-7052, ruschelle.leone@cuanschutz.edu
Ruschelle Leone, PhD
About this study
The goal of this randomized clinical trial is to learn how alcohol use, cannabis use, and using both substances affect whether and how quickly people stop a video being shown to a woman. The study will recruit 312 people from the Metro-Denver area who drink alcohol and use cannabis; half of the participants will be women. The main questions it aims to answer are:
- How do alcohol, cannabis, and their combined use affect whether participants stop the video and how quickly they do so?
- Does alcohol use versus alcohol and cannabis use by others in the scenario affect whether and how quickly participants stop the video?
Read more
Researchers will compare four randomly assigned groups: alcohol only, cannabis only, both alcohol and cannabis, and neither substance. Participants will also be randomly assigned to one of two scenarios involving alcohol use or alcohol and cannabis use by others. These comparisons will help researchers understand how participants' own substance use and substance use by others affect their decisions to intervene.
Participants will:
- Complete a phone call to review the study and schedule a mobile laboratory visit at their home.
- Have their ID checked, complete a breath alcohol test to confirm no alcohol is in their system, and be weighed. Female participants will also take a pregnancy test.
- Provide written consent and complete questionnaires so researchers can confirm eligibility before random assignment.
- Follow their assigned substance-use condition. Participants in the cannabis-only group will smoke their usual cannabis at home while staff monitor them through Zoom. Those in the alcohol-only group will drink two weight-based alcoholic beverages, with a target blood alcohol concentration of 0.08%. Those assigned to both substances will use cannabis first and then drink alcohol. Those assigned to neither substance will not use either as part of the study.
- Provide blood and breath samples to measure cannabis-related THC and alcohol levels.
- Complete a task in which they can choose to stop a video being shown to a woman. Researchers will measure whether they stop the video and how long they take to do so.
- Take part in a recorded interview about their experience and the reasons they did or did not stop the video. Researchers will analyze these interviews to better understand how substance use affects decisions.
- Answer questions about what they believed the study was testing and their impressions of the other participants, receive an explanation of the study, and receive compensation.
- Being tested
- Alcohol beverage, Cannabis (smoked flower), Simultaneous Alcohol and Cannabis, Alcohol Consumption of Others, Alcohol/Cannabis Consumption of Others
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol beverageDrug
Participants will consume a moderate alcohol dose condition (target BrAC .08%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures.
Cannabis (smoked flower)Drug
Participants in this group will self-administer legal-market flower cannabis
Simultaneous Alcohol and CannabisDrug
Participants in this group will self-administer legal-market flower cannabis Participants will consume a moderate alcohol dose condition (target BrAC .08%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures.
Alcohol Consumption of OthersOther
Others in the study will be assigned to drink alcohol
Alcohol/Cannabis Consumption of OthersOther
Others in the study will be assigned to drink alcohol and consume cannabis
No-Alcohol/Cannabis ControlOther
Participants will be assigned to a no-alcohol control beverage and to not consume cannabis.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Consumption + Alcohol Consumption of Others | Experimental | Participants will be assigned to drink alcohol and the others in the study will also be assigned to drink alcohol. Receives: Drug: Alcohol beverage; Other: Alcohol Consumption of Others |
| Alcohol Consumption + Alcohol/Cannabis Consumption of Others | Experimental | Participants will be assigned to drink alcohol and the others in the study will be assigned to drink alcohol and consume cannabis. Receives: Drug: Alcohol beverage; Other: Alcohol/Cannabis Consumption of Others |
| Alcohol/Cannabis Consumption + Alcohol Consumption of Others | Experimental | Participants will be assigned to drink alcohol and consume cannabis; and the others in the study will be assigned to drink alcohol. Receives: Drug: Simultaneous Alcohol and Cannabis; Other: Alcohol Consumption of Others |
| Alcohol/Cannabis Consumption + Alcohol/Cannabis Consumption of Others | Experimental | Participants will be assigned to drink alcohol and consume cannabis; and the others in the study will be assigned to drink alcohol and consume cannabis. Receives: Drug: Simultaneous Alcohol and Cannabis; Other: Alcohol/Cannabis Consumption of Others |
| Sober + Alcohol Consumption of Others | Active comparator | Participants will be assigned to drink a non-alcohol control beverage; and the others in the study will be assigned to drink alcohol. Receives: Other: Alcohol Consumption of Others; Other: No-Alcohol/Cannabis Control |
| Sober + Alcohol/Cannabis Consumption of Others | Active comparator | Participants will be assigned to drink a non-alcohol control beverage; and the others in the study will be assigned to drink alcohol and consume cannabis. Receives: Other: Alcohol/Cannabis Consumption of Others; Other: No-Alcohol/Cannabis Control |
| Cannabis Consumption + Alcohol Consumption of Others | Experimental | Participants will be assigned to consume cannabis, and the others in the study will be assigned to drink alcohol. Receives: Drug: Cannabis (smoked flower); Other: Alcohol Consumption of Others |
| Cannabis Consumption + Alcohol/Cannabis Consumption of Others | Experimental | Participants will be assigned to consume cannabis, and the others in the study will be assigned to drink alcohol and consume cannabis. Receives: Drug: Cannabis (smoked flower); Other: Alcohol/Cannabis Consumption of Others |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Likelihood
Stopping a woman from watching content during the Bystander Intervention Paradigm (Parrott et al., 2012, Leone et al., 2015). Possible scores are 0 (not stopping) to 1 (stopping).
Measured: Up to three hours after consent
Intervention Speed
The amount of time the woman watches the sexually explicit film during the Bystander Intervention Paradigm (Parrott et al., 2012, Leone et al., 2015). Scores range from 0 to 4 minutes.
Measured: Up to three hours after consent
Number of Bystander Barriers
Count number of barriers experienced during the paradigm via a semi-structured interview.
Measured: Up to four hours after consent
Number of Bystander Facilitators
Count number of facilitators experienced during the paradigm via a semi-structured interview.
Measured: Up to four hours after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startMay 2027 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use BehaviorStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Ruschelle Leone, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922239
- Sponsor's protocol ID
- 26-1956
- Other IDs
- R01AA032801
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available in the NIAAA Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use and Media Preferences
- ClinicalTrials.gov ID
- NCT07922239
- Acronym / sponsor ID
- 26-1956
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2027 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 6 Nov 2026 (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 goal of this randomized clinical trial is to learn how alcohol use, cannabis use, and using both substances affect whether and how quickly people stop a video being shown to a woman. The study will recruit 312 people from the Metro-Denver area who drink alcohol and use cannabis; half of the participants will be women. The main questions it aims to answer are:
- How do alcohol, cannabis, and their combined use affect whether participants stop the video and how quickly they do so?
- Does alcohol use versus alcohol and cannabis use by others in the scenario affect whether and how quickly participants stop the video?
Researchers will compare four randomly assigned groups: alcohol only, cannabis only, both alcohol and cannabis, and neither substance. Participants will also be randomly assigned to one of two scenarios involving alcohol use or alcohol and cannabis use by others. These comparisons will help researchers understand how participants' own substance use and substance use by others affect their decisions to intervene.
Participants will:
- Complete a phone call to review the study and schedule a mobile laboratory visit at their home.
- Have their ID checked, complete a breath alcohol test to confirm no alcohol is in their system, and be weighed. Female participants will also take a pregnancy test.
- Provide written consent and complete questionnaires so researchers can confirm eligibility before random assignment.
- Follow their assigned substance-use condition. Participants in the cannabis-only group will smoke their usual cannabis at home while staff monitor them through Zoom. Those in the alcohol-only group will drink two weight-based alcoholic beverages, with a target blood alcohol concentration of 0.08%. Those assigned to both substances will use cannabis first and then drink alcohol. Those assigned to neither substance will not use either as part of the study.
- Provide blood and breath samples to measure cannabis-related THC and alcohol levels.
- Complete a task in which they can choose to stop a video being shown to a woman. Researchers will measure whether they stop the video and how long they take to do so.
- Take part in a recorded interview about their experience and the reasons they did or did not stop the video. Researchers will analyze these interviews to better understand how substance use affects decisions.
- Answer questions about what they believed the study was testing and their impressions of the other participants, receive an explanation of the study, and receive compensation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Alcohol Consumption + Alcohol Consumption of Others | Experimental | Drug: Alcohol beverage, Other: Alcohol Consumption of OthersParticipants will be assigned to drink alcohol and the others in the study will also be assigned to drink alcohol. |
| Alcohol Consumption + Alcohol/Cannabis Consumption of Others | Experimental | Drug: Alcohol beverage, Other: Alcohol/Cannabis Consumption of OthersParticipants will be assigned to drink alcohol and the others in the study will be assigned to drink alcohol and consume cannabis. |
| Alcohol/Cannabis Consumption + Alcohol Consumption of Others | Experimental | Drug: Simultaneous Alcohol and Cannabis, Other: Alcohol Consumption of OthersParticipants will be assigned to drink alcohol and consume cannabis; and the others in the study will be assigned to drink alcohol. |
| Alcohol/Cannabis Consumption + Alcohol/Cannabis Consumption of Others | Experimental | Drug: Simultaneous Alcohol and Cannabis, Other: Alcohol/Cannabis Consumption of OthersParticipants will be assigned to drink alcohol and consume cannabis; and the others in the study will be assigned to drink alcohol and consume cannabis. |
| Sober + Alcohol Consumption of Others | Active comparator | Other: Alcohol Consumption of Others, Other: No-Alcohol/Cannabis ControlParticipants will be assigned to drink a non-alcohol control beverage; and the others in the study will be assigned to drink alcohol. |
| Sober + Alcohol/Cannabis Consumption of Others | Active comparator | Other: Alcohol/Cannabis Consumption of Others, Other: No-Alcohol/Cannabis ControlParticipants will be assigned to drink a non-alcohol control beverage; and the others in the study will be assigned to drink alcohol and consume cannabis. |
| Cannabis Consumption + Alcohol Consumption of Others | Experimental | Drug: Cannabis (smoked flower), Other: Alcohol Consumption of OthersParticipants will be assigned to consume cannabis, and the others in the study will be assigned to drink alcohol. |
| Cannabis Consumption + Alcohol/Cannabis Consumption of Others | Experimental | Drug: Cannabis (smoked flower), Other: Alcohol/Cannabis Consumption of OthersParticipants will be assigned to consume cannabis, and the others in the study will be assigned to drink alcohol and consume cannabis. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and lifestyle considerations .
- Aged 21-30, verified by a photo ID.
- Consume an alcohol quantity on a single occasion that is equal to or greater than the dose administered in the laboratory on ≥ 3 days in the past year (see Table 1).
- Smoked cannabis ≥ 3 days in the past year.
Key exclusion criteria (7 listed)
- Currently being treated or in recovery for alcohol or drug problems; currently interested in seeking treatment for drinking or drug use via self-report.
- Experienced an adverse event while co-using alcohol and cannabis at any time in the past 3 months.
- Any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration as determined by the Study Physician.
- Acute Psychiatric Symptomatology: elevated psychological distress as indicated by a score greater than 65 on the Brief Symptom Inventory.
- Self-report that a participant is trying to get pregnant, currently pregnant, or a positive pregnancy test.
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 |
|---|---|---|
| Alcohol beverageParticipants will consume a moderate alcohol dose condition (target BrAC .08%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures. | Drug | Alcohol Consumption + Alcohol Consumption of Others, Alcohol Consumption + Alcohol/Cannabis Consumption of Others |
| Cannabis (smoked flower)Participants in this group will self-administer legal-market flower cannabis | Drug | Cannabis Consumption + Alcohol Consumption of Others, Cannabis Consumption + Alcohol/Cannabis Consumption of Others |
| Simultaneous Alcohol and CannabisParticipants in this group will self-administer legal-market flower cannabis Participants will consume a moderate alcohol dose condition (target BrAC .08%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures. | Drug | Alcohol/Cannabis Consumption + Alcohol Consumption of Others, Alcohol/Cannabis Consumption + Alcohol/Cannabis Consumption of Others |
| Alcohol Consumption of OthersOthers in the study will be assigned to drink alcohol | Other | Alcohol Consumption + Alcohol Consumption of Others, Alcohol/Cannabis Consumption + Alcohol Consumption of Others, Cannabis Consumption + Alcohol Consumption of Others, Sober + Alcohol Consumption of Others |
| Alcohol/Cannabis Consumption of OthersOthers in the study will be assigned to drink alcohol and consume cannabis | Other | Alcohol Consumption + Alcohol/Cannabis Consumption of Others, Alcohol/Cannabis Consumption + Alcohol/Cannabis Consumption of Others, Cannabis Consumption + Alcohol/Cannabis Consumption of Others, Sober + Alcohol/Cannabis Consumption of Others |
| No-Alcohol/Cannabis ControlParticipants will be assigned to a no-alcohol control beverage and to not consume cannabis. | Other | Sober + Alcohol Consumption of Others, Sober + Alcohol/Cannabis Consumption of Others |
Primary outcome
Intervention Likelihood
Time frame: Up to three hours after consent
Stopping a woman from watching content during the Bystander Intervention Paradigm (Parrott et al., 2012, Leone et al., 2015). Possible scores are 0 (not stopping) to 1 (stopping).
Intervention Speed
Time frame: Up to three hours after consent
The amount of time the woman watches the sexually explicit film during the Bystander Intervention Paradigm (Parrott et al., 2012, Leone et al., 2015). Scores range from 0 to 4 minutes.
Number of Bystander Barriers
Time frame: Up to four hours after consent
Count number of barriers experienced during the paradigm via a semi-structured interview.
Number of Bystander Facilitators
Time frame: Up to four hours after consent
Count number of facilitators experienced during the paradigm via a semi-structured interview.
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 6 Nov 2026.
- Individual participant dataSharing planned: Yes. IPD will be available in the NIAAA Data Archive.
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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.
University of Colorado Anschutz Medical Campus
Denver, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol beverage, Cannabis (smoked flower) and Simultaneous Alcohol and Cannabis in people with Substance Use Behavior and Cannabis Intoxication, run by University of Colorado, Denver 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Likelihood (time frame: Up to three hours after consent). The study lists 4 primary outcomes in all. 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 6 Nov 2026.