- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00451854
Student Athlete Testing Using Random Notification (SATURN)
Student Athlete Drug Surveillance Trail
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University, Divsion of Health Promotion & Sports Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Potential risk and protective factors for drug and alcohol use behavior.
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Collaborators and Investigators
Investigators
- Principal Investigator: Linn Goldberg, M.D., Oregon Health and Science University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA-12018
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