SBI for PSM and PSD

April 30, 2025 updated by: California State University, Long Beach

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 1

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
    • California
      • Long Beach, California, United States, 90840
        • CSULB

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Students complete the assessments at each time point, but do not receive any intervention or informational material.
Behavioral: Control
Students complete the assessments at each time point, but do not receive any intervention or informational material.
Experimental: F2F
After T1 assessment, students meet with a trained provider and receive prevention or brief intervention. Students then complete assessments at two additional times.
Behavioral: F2F
After T1 assessment, students meet with a trained provider and receive prevention or brief intervention. Students then complete assessments at two additional times.
Experimental: eSBI
After T1 assessment, students watch and respond to a prevention or brief intervention video series. Students then complete assessments at two additional times.
Behavioral: eSBI
After T1 assessment, students watch and respond to a prevention or brief intervention video series. Students then complete assessments at two additional times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSM Intentions
Time Frame: 30 days
Intention to engage in PSM is measured at T1 (pre-intervention), T2 (immediate post), and T3 (30 Day post intervention)
30 days
PSD Intentions
Time Frame: 30 days
Intention to engage in PSM is measured at T1 (pre-intervention), T2 (immediate post), and T3 (30 Day post intervention).
30 days

Collaborators and Investigators

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

Sponsor

California State University, Long Beach

Collaborators

National Institute on Drug Abuse (NIDA)

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 (Actual)

October 1, 2024

Primary Completion (Estimated)

August 11, 2025

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R34DA056596 (U.S. NIH Grant/Contract)
  • 1R34DA056596-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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