AlcoholNCT07905846
A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
A study testing Online and Text Message Intervention in people with Alcohol and Cannabis, run by The University of Texas at Arlington.
Trial summary
Building on promising pilot findings, this study will employ a Hybrid Type 1 Effectiveness-Implementation RCT to evaluate the effectiveness of a novel intervention for first-year college students who abstain from or use alcohol and cannabis lightly, compared to assessment-only control. Read more about this study
- Who is it for?
- Ages 18 to 19 yearsHealthy volunteers can take part
- What is being tested?
- Online and Text Message Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2028to Aug 2030
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: 1) 18-19 at the time of screening; 2) birthdate consistent with age; 3) first-year student at UTA; 4) no lifetime alcohol use or alcohol use in the past month limited to one day per week or less and never exceeding 4 drinks (women) or 5 drinks (men) on a single occasion at any point in their lifetime; 5) no lifetime cannabis use or cannabis use in the past month limited to one day per week or less and never exceeding that frequency at any point in their lifetime; 6) valid email; 7) valid mobile number with TM plan; and 8) no past or current treatment for alcohol or cannabis.
Exclusion Criteria: Exclusion criteria include not meeting inclusion criteria (see Inclusion Criteria above), unwillingness to participate, failure to provide consent (e.g., declining participation in the study), providing inconsistent responses (e.g., age) identified by the eligibility survey and introductory study telephone call, and having already participated in the study as identified by overlap or consistency in computer IP addresses, contact information, and demographics.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Building on promising pilot findings, this study will employ a Hybrid Type 1 Effectiveness-Implementation RCT to evaluate the effectiveness of a novel intervention for first-year college students who abstain from or use alcohol and cannabis lightly, compared to assessment-only control. Aim 1 will finalize the intervention through student feedback to ensure relevance and engagement and Aim 2 will test its impact on abstaining and light alcohol and cannabis use, related consequences, and key cognitive and behavioral outcomes in a two-arm RCT (N = 800) across the first semester and academic year. Aim 3 will assess early implementation outcomes using mixed methods, including focus groups with a Campus Advisory Board, validated survey measures, and intervention analytics, to inform future dissemination and implementation strategies.
- Being tested
- Online and Text Message Intervention
- Keywords
- college, prevention, alcohol, cannabis
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online and Text Message InterventionBehavioural
Participants in the intervention condition will receive a brief web-based personalized feedback intervention, which will use participant data reported in the baseline assessment. Text message intervention content will fall into five categories informed by our prior formative work: (1) prototypes, (2) norms, (3) perceived vulnerability, (4) personal goals, and (5) substance-free activities. The intervention is designed to shift the emphasis from reducing heavy use to preventing initiation and escalation by incorporating content that supports students' existing decisions to maintain their abstinence or infrequent alcohol and cannabis use while supporting broader well-being through alternative activities, goal-setting, and peer connections.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | Participants in intervention group will receive a web-based personalized feedback intervention and 6 intervention text messages per week (2 text messages per day, 3 days per week) across 12 weeks (first semester of college). Receives: Behavioral: Online and Text Message Intervention |
| Assessment-only Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Initiation
Alcohol initiation for those who abstain at baseline will be calculated as time-to-event from baseline date to the approximate date they first used alcohol.
Measured: From enrollment to 8 month follow-up
Cannabis Initiation
Cannabis initiation for those who abstain at baseline will be calculated as time-to-event from baseline date to the approximate date they first used cannabis
Measured: From enrollment to 8 month follow-up
Alcohol Consumption
Alcohol consumption will be assessed using the Daily Drinking Questionnaire, a validated self-report measure assessing the number of standard alcoholic drinks typically consumed on each day of the week, allowing calculation of typical weekly alcohol consumption and drinking frequency.
Measured: 4 and 8 month follow-up
Cannabis Consumption
Cannabis consumption will be assessed using a measure parallel to the Daily Drinking Questionnaire, and will assess the number of hours high on each day of the week, allowing calculation of typical cannabis use and frequency.
Measured: 4 and 8 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Sep 2028 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Institute on Alcohol Abuse and Alcoholism (NIAAA), The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Dana Litt, The University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905846
- Sponsor's protocol ID
- 2026-0434
- Other IDs
- R01AA033553
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
- ClinicalTrials.gov ID
- NCT07905846
- Acronym / sponsor ID
- 2026-0434
- Keywords
- college, prevention, alcohol, cannabis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Collaborators
- University of Washington, National Institute on Alcohol Abuse and Alcoholism (NIAAA), The University of Texas Health Science Center, Houston
- Study start
- 1 Sep 2028 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 30 Oct 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.
Building on promising pilot findings, this study will employ a Hybrid Type 1 Effectiveness-Implementation RCT to evaluate the effectiveness of a novel intervention for first-year college students who abstain from or use alcohol and cannabis lightly, compared to assessment-only control. Aim 1 will finalize the intervention through student feedback to ensure relevance and engagement and Aim 2 will test its impact on abstaining and light alcohol and cannabis use, related consequences, and key cognitive and behavioral outcomes in a two-arm RCT (N = 800) across the first semester and academic year. Aim 3 will assess early implementation outcomes using mixed methods, including focus groups with a Campus Advisory Board, validated survey measures, and intervention analytics, to inform future dissemination and implementation strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: Online and Text Message InterventionParticipants in intervention group will receive a web-based personalized feedback intervention and 6 intervention text messages per week (2 text messages per day, 3 days per week) across 12 weeks (first semester of college). |
| Assessment-only Control | No intervention | – |
Who may qualify
- Ages
- 18 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Online and Text Message InterventionParticipants in the intervention condition will receive a brief web-based personalized feedback intervention, which will use participant data reported in the baseline assessment. Text message intervention content will fall into five categories informed by our prior formative work: (1) prototypes, (2) norms, (3) perceived vulnerability, (4) personal goals, and (5) substance-free activities. The intervention is designed to shift the emphasis from reducing heavy use to preventing initiation and escalation by incorporating content that supports students' existing decisions to maintain their abstinence or infrequent alcohol and cannabis use while supporting broader well-being through alternative activities, goal-setting, and peer connections. | Behavioural | Intervention Condition |
Primary outcome
Alcohol Initiation
Time frame: From enrollment to 8 month follow-up
Alcohol initiation for those who abstain at baseline will be calculated as time-to-event from baseline date to the approximate date they first used alcohol.
Cannabis Initiation
Time frame: From enrollment to 8 month follow-up
Cannabis initiation for those who abstain at baseline will be calculated as time-to-event from baseline date to the approximate date they first used cannabis
Alcohol Consumption
Time frame: 4 and 8 month follow-up
Alcohol consumption will be assessed using the Daily Drinking Questionnaire, a validated self-report measure assessing the number of standard alcoholic drinks typically consumed on each day of the week, allowing calculation of typical weekly alcohol consumption and drinking frequency.
Cannabis Consumption
Time frame: 4 and 8 month follow-up
Cannabis consumption will be assessed using a measure parallel to the Daily Drinking Questionnaire, and will assess the number of hours high on each day of the week, allowing calculation of typical cannabis use and frequency.
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 30 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Online and Text Message Intervention in people with Alcohol and Cannabis, run by The University of Texas at Arlington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Dana Litt, PhD (817-272-9822, starrlab@uta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Initiation (time frame: From enrollment to 8 month follow-up). 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 30 Oct 2026.