Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal

• Sponsor: Real Prevention, LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05209191
• Collaborator: University of Missouri-Columbia (Other)
• Enrollment: 400
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 27.2
• Patients Per Site: 200
• Patients Per Site Per Month: 7.4

Study Details

Study Description

Brief Summary

The goal of this study is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention.

Condition or Disease	Intervention/Treatment	Phase
Opioid Misuse	Behavioral: Student Athlete Wellness Portal	N/A

Detailed Description

The goal of this proposal is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention. The new program, the Student Athlete Wellness Portal (SAWP), will be a brief, web- and smartphone-based curriculum, and will encourage resistance to cultural influences to misuse prescription opioids. This portal, which was created based on formative interviews with athletes, coaches, athletic trainers, and school administrators, will be tested in a feasibility trial in four Texas high schools. Two high schools will be given the treatment (the SAWP) and two high schools will serve as the control and will receive a lesson on proper nutrition and sports. All athletes will complete a pretest and posttest to assess their knowledge, perceptions, and behaviors relating to opioid medication.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participating schools randomly assigned to treatment and waitlisted control conditions.Participating schools randomly assigned to treatment and waitlisted control conditions.
• Masking: None (Open Label)
• Masking Description: Participants will know if they are receiving the Student Athlete Wellness Portal intervention during the study or afterwards.
• Primary Purpose: Prevention
• Official Title: Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
• Actual Study Start Date: Apr 24, 2020
• Anticipated Primary Completion Date: May 31, 2022
• Anticipated Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Student Athlete Wellness Portal Web-based intervention that illustrates opioid misuse and diversion resistance strategies.	Behavioral: Student Athlete Wellness Portal; A web-based design that illustrates various opioid misuse and diversion resistance strategies.
Active Comparator: Student Athlete Nutritional Program Web-based intervention that teaches about healthy eating habits for athletes.	Behavioral: Student Athlete Wellness Portal; A web-based design that illustrates various opioid misuse and diversion resistance strategies.

Outcome Measures

Primary Outcome Measures

1. Incidence of Prescription Opioid Misuse [Past 6 months]

   Survey scale measuring frequency of nonmedical and medical precription opioid misuse prescription opioids

2. Likelihood of Prescription Opioid Misuse Intention [In the next 6 months]

   Survey scales measuring the degree of likelihood of opioid misuse

3. Incidence of Prescription Opioid Diversion or Sharing [Past 6 months]

   Survey scale measuring frequency of diversion of prescription opioids

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• English-speaking male and female adolescents

• Agesd 13-19

• Attending middle or high school

• Playing at last one interscholastic sport

• Parental consent

Exclusion Criteria:

• No parental consent

• outside the age range

• not participating in interscholastic sports

• not in middle or high school

• participated in the Phase I research

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clifton High School	Clifton	New Jersey	United States	07013
2	Dickinson High School	Galveston	Texas	United States	77539

Sponsors and Collaborators

• Real Prevention, LLC
• University of Missouri-Columbia

Investigators

• Principal Investigator: Michael L Hecht, Real Prevention, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Hecht, President, Real Prevention, LLC
• ClinicalTrials.gov Identifier: NCT05209191
• Other Study ID Numbers: R44DA051243-01
• First Posted: Jan 26, 2022
• Last Update Posted: Jan 26, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michael Hecht, President, Real Prevention, LLC: prescription opioid misuse; presecription opioid diversion
• Additional relevant MeSH terms: Opioid-Related Disorders

Study Results

No Results Posted as of Jan 26, 2022