Prescription Stimulant MisusePhase 1NCT06923384
SBI for PSM and PSD
A Phase 1 study testing F2F and eSBI in people with Prescription Stimulant Misuse and Prescription Stimulant Diversion, run by California State University, Long Beach at 1 site in United States.
Trial summary
A pilot randomized controlled trial to assess the feasibility, acceptability, and impact of screening and brief intervention to address prescription stimulant misuse and diversion among college students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prescription Stimulant Misuse, Prescription Stimulant Diversion
- What is being tested?
- F2F and eSBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 May 2026
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and student at the campus serving as the intervention site; Passive recruitment: Student has a scheduled appointment for a physical/wellness exam. Active recruitment: Student has a past 3 month history of PSM or PSD.
Who cannot join
- Any eligible student who, during the course of the session, demonstrates the need for immediate mental health services, will have the study session terminated so that participant can receive needed care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Screening and Brief Intervention for Prescription Stimulant Misuse and Diversion: Refining and Piloting a Curriculum for College Health Providers
A pilot randomized controlled trial to assess the feasibility, acceptability, and impact of screening and brief intervention to address prescription stimulant misuse and diversion among college students.
Read the detailed description
A screening and brief intervention including a control group, face-to-face group, and e-intervention group where the focus is prevention or brief intervention or referral to treatment related to students prescription stimulant misuse and diversion behaviors. Students will complete assessments at three time points, and the health providers who implement the intervention will also complete assessments.
- Being tested
- F2F, eSBI, Control
- Keywords
- prescription stimulants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F2FBehavioural
After T1 assessment, students meet with a trained provider and receive prevention or brief intervention. Students then complete assessments at two additional times.
eSBIBehavioural
After T1 assessment, students watch and respond to a prevention or brief intervention video series. Students then complete assessments at two additional times.
ControlBehavioural
Students complete the assessments at each time point, but do not receive any intervention or informational material.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Students complete the assessments at each time point, but do not receive any intervention or informational material. Receives: Behavioral: Control |
| F2F | Experimental | After T1 assessment, students meet with a trained provider and receive prevention or brief intervention. Students then complete assessments at two additional times. Receives: Behavioral: F2F |
| eSBI | Experimental | After T1 assessment, students watch and respond to a prevention or brief intervention video series. Students then complete assessments at two additional times. Receives: Behavioral: eSBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription Stimulant Misuse
Students report on their experience with prescription stimulant misuse behaviors. PSM is assessed at T1, pre-intervention, and T3, 30-Days post intervention.
Measured: 30 days
Prescription Stimulant Diversion
Students report on their experience with prescription stimulant diversion behaviors. PSD is assessed at T1, pre-intervention, and T3, 30-Days post intervention.
Measured: 30 days
Secondary outcomes (2)
PSM Intentions
Intention to engage in PSM is measured at T1 (pre-intervention), T2 (immediate post), and T3 (30 Day post intervention)
Measured: 30 days
PSD Intentions
Intention to engage in PSM is measured at T1 (pre-intervention), T2 (immediate post), and T3 (30 Day post intervention).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Oct 2024
- Primary completion11 Aug 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prescription Stimulant MisuseStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three conditions: control, face-to-face intervention with trained providers, or e-Intervention that involves watching a video from a health provider and responding to questions.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California State University, Long Beach
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923384
- Sponsor's protocol ID
- R34DA056596
- Other IDs
- 1R34DA056596-01A1
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared due to confidentiality agreements with participants, but study protocol, analysis plan, informed consent, and clinical study reports will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Brief Intervention for Prescription Stimulant Misuse and Diversion: Refining and Piloting a Curriculum for College Health Providers
- ClinicalTrials.gov ID
- NCT06923384
- Acronym / sponsor ID
- R34DA056596
- Keywords
- prescription stimulants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- California State University, Long BeachUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 11 Aug 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 11 Apr 2025 (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.
A pilot randomized controlled trial to assess the feasibility, acceptability, and impact of screening and brief intervention to address prescription stimulant misuse and diversion among college students.
Detailed description
A screening and brief intervention including a control group, face-to-face group, and e-intervention group where the focus is prevention or brief intervention or referral to treatment related to students prescription stimulant misuse and diversion behaviors. Students will complete assessments at three time points, and the health providers who implement the intervention will also complete assessments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three conditions: control, face-to-face intervention with trained providers, or e-Intervention that involves watching a video from a health provider and responding to questions.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: ControlStudents complete the assessments at each time point, but do not receive any intervention or informational material. |
| F2F | Experimental | Behavioral: F2FAfter T1 assessment, students meet with a trained provider and receive prevention or brief intervention. Students then complete assessments at two additional times. |
| eSBI | Experimental | Behavioral: eSBIAfter T1 assessment, students watch and respond to a prevention or brief intervention video series. Students then complete assessments at two additional times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 and student at the campus serving as the intervention site; Passive recruitment: Student has a scheduled appointment for a physical/wellness exam. Active recruitment: Student has a past 3 month history of PSM or PSD.
Key exclusion criteria (1 listed)
- Any eligible student who, during the course of the session, demonstrates the need for immediate mental health services, will have the study session terminated so that participant can receive needed care.
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 |
|---|---|---|
| F2FAfter T1 assessment, students meet with a trained provider and receive prevention or brief intervention. Students then complete assessments at two additional times. | Behavioural | F2F |
| eSBIAfter T1 assessment, students watch and respond to a prevention or brief intervention video series. Students then complete assessments at two additional times. | Behavioural | eSBI |
| ControlStudents complete the assessments at each time point, but do not receive any intervention or informational material. | Behavioural | Control |
Primary outcome
Prescription Stimulant Misuse
Time frame: 30 days
Students report on their experience with prescription stimulant misuse behaviors. PSM is assessed at T1, pre-intervention, and T3, 30-Days post intervention.
Prescription Stimulant Diversion
Time frame: 30 days
Students report on their experience with prescription stimulant diversion behaviors. PSD is assessed at T1, pre-intervention, and T3, 30-Days post intervention.
2 secondary outcomes
PSM Intentions
Time frame: 30 days
PSD Intentions
Time frame: 30 days
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 4 May 2025.
- Individual participant dataSharing planned: No. Individual data will not be shared due to confidentiality agreements with participants, but study protocol, analysis plan, informed consent, and clinical study reports will be shared.
Related trials for Prescription Stimulant Misuse
Recruiting
Kentucky Women's Justice Community Overdose Innovation Network - Phase II
Overdose Risk, Opioid Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F2F and eSBI in people with Prescription Stimulant Misuse and Prescription Stimulant Diversion, run by California State University, Long Beach 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 1 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: enrolling by invitation, as of the sponsor's last update on 4 May 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription Stimulant Misuse (time frame: 30 days). The study lists 2 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 4 May 2025.