SBI for PSM and PSD

NCT ID: NCT06923384

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-05-30

Brief Summary

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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

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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.

Conditions

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Prescription Stimulant Misuse Prescription Stimulant Diversion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

F2F

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

Group Type EXPERIMENTAL

F2F

Intervention Type BEHAVIORAL

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

eSBI

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

Group Type EXPERIMENTAL

eSBI

Intervention Type BEHAVIORAL

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

Interventions

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F2F

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

California State University, Long Beach

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CSULB

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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1R34DA056596-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R34DA056596

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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