SBI for PSM and PSD

NCT06923384 | Enrolling By Invitation Phase 1

• 2 other identifiers: R34DA0565961R34DA056596-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prescription Stimulant Misuse; Prescription Stimulant Diversion

Keywords

prescription stimulants

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 days

Secondary Outcomes (2)

• PSM Intentions

  30 days

• PSD Intentions

  30 days

Study Arms (3)

Control

PLACEBO COMPARATOR

Students complete the assessments at each time point, but do not receive any intervention or informational material.

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.

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.

Behavioral: eSBI

Interventions

F2F BEHAVIORAL

After T1 assessment, students meet with a trained provider and receive prevention or brief intervention. Students then complete assessments at two additional times.

F2F

eSBI BEHAVIORAL

After T1 assessment, students watch and respond to a prevention or brief intervention video series. Students then complete assessments at two additional times.

eSBI

Control BEHAVIORAL

Students complete the assessments at each time point, but do not receive any intervention or informational material.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• California State University, Long Beach: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

CSULB

Long Beach, California, 90840, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: October 1, 2024
• Primary Completion: August 11, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)