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Student Athlete Testing Using Random Notification (SATURN)

Primary Purpose

Drug Abuse, Alcohol Abuse, Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Random, no advanced notice drug and alcohol testing
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Abuse focused on measuring Drug testing, Adolescence, Student athlete, Substance abuse, Alcohol use, Drug use

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Schools without previous drug and alcohol testing policies, willing to design and implement a drug and alcohol policy conforming to the United States Supreme Court Decision (Acton v Vernonia, willing to be randomized to an active drug testing or control (deferred testing) condition, and agreement of school district school board and principals

Exclusion Criteria:

- Schools with current alcohol or drug testing policy, unwillingness to be randomized to control and drug testing

Sites / Locations

  • Oregon Health & Science University, Divsion of Health Promotion & Sports Medicine

Outcomes

Primary Outcome Measures

The specific measure that will be used to determine the effect of the intervention on drug and alcohol use as determined by confidential and anonymous surveys.

Secondary Outcome Measures

Potential risk and protective factors for drug and alcohol use behavior.

Full Information

First Posted
March 23, 2007
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00451854
Brief Title
Student Athlete Testing Using Random Notification
Acronym
SATURN
Official Title
Student Athlete Drug Surveillance Trail
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the influence of drug testing on risk and protective factors of substance abuse among adolescents; examine whether drug and alcohol testing among high school athletes leads to reduced drug and alcohol use; and assess the use of drugs and alcohol among student athletes and non-athletes.
Detailed Description
This proposal is designed to address the increase in drug use among adolescent athletes by studying a school-based version of the random, no-advance warning drug testing program used by the United States Olympic Committee (USOC). High school athletes are a large group, comprising 50% of their school's enrollment. They have a high rate of substance abuse behaviors similar to the general school population, and an even higher use of 'ergrogenic' (athletic enhancing) drugs. Recognizing the high rate of substance abuse among young athletes and their 'role model' effect on other students, the U.S. Supreme Court recently upheld an Oregon School Districts' policy to randomly drug test students engaged in school-sponsored sports. Drug testing has the potential to deter adolescent substance abuse. It is gender-neutral, without ethnic bias and provides a potentially powerful environmental influence. However, despite its legality and theorized effectiveness, schools are implementing drug surveillance without the benefit of randomized, prospective efficacy research. Focusing on adolescent athletes provides a unique opportunity to study the prevention effect of drug testing. All sports teams in 24 schools who agree to implement mandatory testing as school policy but have never implemented this policy, will be randomly assigned by school, to three years of either: 1) random, no-advance warning drug testing or 2) a 3-year control period without testing. Selection of students for drug testing will be random, with no exclusions for having been previously tested. State-of-the-art testing will include physician specimen collectors under the direction of research physicians (PI & Co-I), who are Certified USOC Drug Surveillance Crew Chiefs, with specimen analysis at the UCLA Olympic Laboratory using the most accurate analytical techniques to minimize false negative (reducing policy integrity) and false positive (mislabeling students) results. Confidential questionnaires will be completed by student-athletes twice yearly to assess risk and protective factors for drug use and assess self-reported substance abuse. The role model effect of the surveillance program on nonathletes' drug use will be assessed twice yearly by anonymous survey. We will determine the effect of drug testing policy on: 1) adolescent drug use mediators, 2) actual drug use behaviors of student-athletes and their non-athlete peers, and 3) potential gender and demographic differences. Reliability of subjective questionnaire responses will be assessed by comparisons with objective drug test results. Study findings will assist school districts and education agencies evaluate, guide, and implement future drug prevention policy decisions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse, Alcohol Abuse, Substance Abuse
Keywords
Drug testing, Adolescence, Student athlete, Substance abuse, Alcohol use, Drug use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Random, no advanced notice drug and alcohol testing
Primary Outcome Measure Information:
Title
The specific measure that will be used to determine the effect of the intervention on drug and alcohol use as determined by confidential and anonymous surveys.
Secondary Outcome Measure Information:
Title
Potential risk and protective factors for drug and alcohol use behavior.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Schools without previous drug and alcohol testing policies, willing to design and implement a drug and alcohol policy conforming to the United States Supreme Court Decision (Acton v Vernonia, willing to be randomized to an active drug testing or control (deferred testing) condition, and agreement of school district school board and principals Exclusion Criteria: - Schools with current alcohol or drug testing policy, unwillingness to be randomized to control and drug testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linn Goldberg, M.D.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University, Divsion of Health Promotion & Sports Medicine
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12507797
Citation
Goldberg L, Elliot DL, MacKinnon DP, Moe E, Kuehl KS, Nohre L, Lockwood CM. Drug testing athletes to prevent substance abuse: background and pilot study results of the SATURN (Student Athlete Testing Using Random Notification) study. J Adolesc Health. 2003 Jan;32(1):16-25. doi: 10.1016/s1054-139x(02)00444-5. Erratum In: J Adolesc Health. 2003 Apr;32(4):325.
Results Reference
result
PubMed Identifier
17950161
Citation
Goldberg L, Elliot DL, MacKinnon DP, Moe EL, Kuehl KS, Yoon M, Taylor A, Williams J. Outcomes of a prospective trial of student-athlete drug testing: the Student Athlete Testing Using Random Notification (SATURN) study. J Adolesc Health. 2007 Nov;41(5):421-9. doi: 10.1016/j.jadohealth.2007.08.001. Erratum In: J Adolesc Health. 2008 Jan;42(1):107.
Results Reference
derived

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Student Athlete Testing Using Random Notification

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