Substance Use and Media Preferences

November 2, 2026 updated by: Ruschelle Leone, University of Colorado, Denver

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
312

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
        • Contact:
        • Principal Investigator:
          • Ruschelle Leone, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.
  2. Stated willingness to comply with all study procedures and lifestyle considerations .
  3. Aged 21-30, verified by a photo ID.
  4. 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).
  5. Smoked cannabis ≥ 3 days in the past year.
  6. Engaging in simultaneous alcohol and cannabis use ≥ 1 day in the past year.

Exclusion Criteria:

  1. Currently being treated or in recovery for alcohol or drug problems; currently interested in seeking treatment for drinking or drug use via self-report.
  2. Experienced an adverse event while co-using alcohol and cannabis at any time in the past 3 months.
  3. Any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration as determined by the Study Physician.
  4. Acute Psychiatric Symptomatology: elevated psychological distress as indicated by a score greater than 65 on the Brief Symptom Inventory.
  5. Self-report that a participant is trying to get pregnant, currently pregnant, or a positive pregnancy test.
  6. 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.
  7. Current or past participation in PI Leone's research study 'Understanding the Influence of Alcohol and Media on Relationships' protocol #24-1867.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Alcohol Consumption + Alcohol Consumption of Others

Participants will be assigned to drink alcohol and the others in the study will also be assigned to drink alcohol.
Drug: Alcohol beverage

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.

Other: Alcohol Consumption of Others

Others in the study will be assigned to drink alcohol
Experimental: Alcohol Consumption + Alcohol/Cannabis Consumption of Others

Participants will be assigned to drink alcohol and the others in the study will be assigned to drink alcohol and consume cannabis.
Drug: Alcohol beverage

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.

Other: Alcohol/Cannabis Consumption of Others

Others in the study will be assigned to drink alcohol and consume cannabis
Experimental: Alcohol/Cannabis Consumption + Alcohol Consumption of Others

Participants will be assigned to drink alcohol and consume cannabis; and the others in the study will be assigned to drink alcohol.
Other: Alcohol Consumption of Others

Others in the study will be assigned to drink alcohol

Drug: Simultaneous Alcohol and Cannabis

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.
Experimental: Alcohol/Cannabis Consumption + Alcohol/Cannabis Consumption of Others

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.
Other: Alcohol/Cannabis Consumption of Others

Others in the study will be assigned to drink alcohol and consume cannabis

Drug: Simultaneous Alcohol and Cannabis

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.
Active Comparator: Sober + Alcohol Consumption of Others

Participants will be assigned to drink a non-alcohol control beverage; and the others in the study will be assigned to drink alcohol.
Other: Alcohol Consumption of Others

Others in the study will be assigned to drink alcohol

Other: No-Alcohol/Cannabis Control

Participants will be assigned to a no-alcohol control beverage and to not consume cannabis.
Active Comparator: Sober + Alcohol/Cannabis Consumption of Others

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.
Other: Alcohol/Cannabis Consumption of Others

Others in the study will be assigned to drink alcohol and consume cannabis

Other: No-Alcohol/Cannabis Control

Participants will be assigned to a no-alcohol control beverage and to not consume cannabis.
Experimental: Cannabis Consumption + Alcohol Consumption of Others

Participants will be assigned to consume cannabis, and the others in the study will be assigned to drink alcohol.
Other: Alcohol Consumption of Others

Others in the study will be assigned to drink alcohol

Drug: Cannabis (smoked flower)

Participants in this group will self-administer legal-market flower cannabis
Experimental: Cannabis Consumption + Alcohol/Cannabis Consumption of Others

Participants will be assigned to consume cannabis, and the others in the study will be assigned to drink alcohol and consume cannabis.
Other: Alcohol/Cannabis Consumption of Others

Others in the study will be assigned to drink alcohol and consume cannabis

Drug: Cannabis (smoked flower)

Participants in this group will self-administer legal-market flower cannabis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to three hours after consent
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.
Up to three hours after consent
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.
Up to four hours after consent
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.
Up to four hours after consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-1956
  • R01AA032801 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available in the NIAAA Data Archive.

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.

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