Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis ContentNCT07726004
Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women
A study testing Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program in people with Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis Content, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the feasibility of the Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program with alcohol and cannabis content (EAAA+) in undergraduate college women between ages 18-24 years old who use alcohol and cannabis. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis Content
- What is being tested?
- Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Feb 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 18 to 24 years
- Women only
- 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 availability for the duration of the study determined at pre-screening
- Between the ages of 18-24 years old determined at pre-screening
- Identifies as a woman determined at pre-screening
- Is currently enrolled as an undergraduate in Colorado with a valid student email address determined at pre-screening
- Engaged in heavy episodic drinking (i.e., 4+ drinks within a two-hour period) at least once in the past month with an intention to drink in the future determined at pre-screening
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- Engaged in using cannabis at least once in the past month with an intention to use in the future determined at pre-screening
- Is available to attend sessions on specific dates
- Has a phone they can complete web-based surveys on determined at pre-screening
Who cannot join
- 1. There are no exclusion criteria aside from not meeting inclusion criteria.
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
Aurora, Colorado, 80045
Ruschelle M Leone, PhD, 303-724-7052, ruschelle.leone@cuanschutz.edu
Ruschelle M Leone, PhD
About this study
Official title: Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women, Pilot RCT
The goal of this clinical trial is to assess the feasibility of the Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program with alcohol and cannabis content (EAAA+) in undergraduate college women between ages 18-24 years old who use alcohol and cannabis. The main objectives it aims to answer are:
- To determine the feasibility of a randomized controlled trial comparing EAAA+ to an assessment only control condition.
- To determine if EAAA+ will result in larger decreases in HED and cannabis use, more accurate perceptions of alcohol and cannabis norms, and greater increases in PBS at follow up.
- To determine if EAAA+ will result in (1) greater increases in SA risk perception and use of assertive SA resistance strategies and (2) decreased barriers to SA resistance while using alcohol and cannabis, and (3) greater reductions in incapacitated SA.
Read more
Researchers will compare participants who received EAAA+ to an assessment only condition to test the objectives stated above.
Participants will:
- Sign an informed consent form and complete a survey. Once the survey is completed, they will be randomly assigned to complete the sexual assault education program or not.
- Participants assigned to the sexual assault education program will complete two in-person sessions (about 7 hours each) or four in-person sessions (about 3.5 hours each) and will also complete an online module in between modules 2 and 3 as part of the education program and complete four short surveys.
- Complete 4 weeks of assessments and complete a follow-up survey at 1, 3, and 6 months after the initial session.
- Being tested
- Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program, Assessment Only Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance ProgramBehavioural
Participants will be randomized to EAAA+, a combined program for alcohol and cannabis prevention and sexual assault risk reduction.
Assessment Only ControlBehavioural
Participants will be randomized to an assessment only control.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program | Experimental | Not described Receives: Behavioral: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program |
| Assessment Only Control | Active comparator | Not described Receives: Behavioral: Assessment Only Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis Use Frequency Measured at Follow-Ups
Cannabis use frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Measured: Up to 1-month, 3-months, and 6-months post intervention
Heavy Episodic Drinking Frequency Measured at Follow-Ups
Heavy episodic drinking (HED) frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Measured: Up to 1-month, 3-months, and 6-months post intervention
Attempted Sexual Assault Measured at Follow-Ups
Attempted sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Measured: Up to 1-month, 3-months, and 6-months post intervention
Completed Sexual Assault Measured at Follow-Ups
Completed sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Measured: Up to 1-month, 3-months, and 6-months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis ContentStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726004
- Sponsor's protocol ID
- 24-2079
- Other IDs
- K01AA028844
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Alcohol, Cannabis, and Sexual Assault Risk Reduction Program for High Risk College Women, Pilot RCT
- ClinicalTrials.gov ID
- NCT07726004
- Acronym / sponsor ID
- 24-2079
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Jul 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 clinical trial is to assess the feasibility of the Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program with alcohol and cannabis content (EAAA+) in undergraduate college women between ages 18-24 years old who use alcohol and cannabis. The main objectives it aims to answer are:
- To determine the feasibility of a randomized controlled trial comparing EAAA+ to an assessment only control condition.
- To determine if EAAA+ will result in larger decreases in HED and cannabis use, more accurate perceptions of alcohol and cannabis norms, and greater increases in PBS at follow up.
- To determine if EAAA+ will result in (1) greater increases in SA risk perception and use of assertive SA resistance strategies and (2) decreased barriers to SA resistance while using alcohol and cannabis, and (3) greater reductions in incapacitated SA.
Researchers will compare participants who received EAAA+ to an assessment only condition to test the objectives stated above.
Participants will:
- Sign an informed consent form and complete a survey. Once the survey is completed, they will be randomly assigned to complete the sexual assault education program or not.
- Participants assigned to the sexual assault education program will complete two in-person sessions (about 7 hours each) or four in-person sessions (about 3.5 hours each) and will also complete an online module in between modules 2 and 3 as part of the education program and complete four short surveys.
- Complete 4 weeks of assessments and complete a follow-up survey at 1, 3, and 6 months after the initial session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program | Experimental | Behavioral: Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program |
| Assessment Only Control | Active comparator | Behavioral: Assessment Only Control |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study determined at pre-screening
- Between the ages of 18-24 years old determined at pre-screening
- Identifies as a woman determined at pre-screening
- Is currently enrolled as an undergraduate in Colorado with a valid student email address determined at pre-screening
Key exclusion criteria (1 listed)
- 1. There are no exclusion criteria aside from not meeting inclusion criteria.
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 |
|---|---|---|
| Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance ProgramParticipants will be randomized to EAAA+, a combined program for alcohol and cannabis prevention and sexual assault risk reduction. | Behavioural | Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program |
| Assessment Only ControlParticipants will be randomized to an assessment only control. | Behavioural | Assessment Only Control |
Primary outcome
Cannabis Use Frequency Measured at Follow-Ups
Time frame: Up to 1-month, 3-months, and 6-months post intervention
Cannabis use frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Heavy Episodic Drinking Frequency Measured at Follow-Ups
Time frame: Up to 1-month, 3-months, and 6-months post intervention
Heavy episodic drinking (HED) frequency will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Attempted Sexual Assault Measured at Follow-Ups
Time frame: Up to 1-month, 3-months, and 6-months post intervention
Attempted sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.
Completed Sexual Assault Measured at Follow-Ups
Time frame: Up to 1-month, 3-months, and 6-months post intervention
Completed sexual assault will be reported using a self-report at 1-month and 3- and 6-month follow ups.
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 24 Jul 2026.
- Individual participant dataSharing planned: Yes. IPD will be available in the NIAAA Data Archive.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program in people with Enhanced Assess, Acknowledge, and Act Sexual Assault Resistance Program With Alcohol and Cannabis Content, 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 9 inclusion and 1 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 24 Jul 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?
Contact Ruschelle M Leone, PhD (303-724-7052, ruschelle.leone@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis Use Frequency Measured at Follow-Ups (time frame: Up to 1-month, 3-months, and 6-months post intervention). 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 24 Jul 2026.