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AzTrials

Drug AbuseSATURNNCT00451854

Student Athlete Testing Using Random Notification

A study testing Random, no advanced notice drug and alcohol testing in people with Drug Abuse and Alcohol Abuse, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Drug Abuse, Alcohol Abuse, Substance Abuse
What is being tested?
Random, no advanced notice drug and alcohol testing
Type of treatment
Surgery or procedure
How many people
14,000 participants
Where
1 siteUnited States
Study dates
Sep 1999to Oct 2002
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oregon Health & Science University, Divsion of Health Promotion & Sports Medicine

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Student Athlete Drug Surveillance Trail

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.

Read the 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.

Being tested
Random, no advanced notice drug and alcohol testing
Keywords
Drug testing, Adolescence, Student athlete, Substance abuse, Alcohol use, Drug use
Medical subject headings
Substance-Related Disorders, Alcoholism, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Random, no advanced notice drug and alcohol testingProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 outcomes (1)
  1. Potential risk and protective factors for drug and alcohol use behavior.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2007 (estimated)
  2. Study startSep 1999
  3. Study completionOct 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00451854
Sponsor's protocol ID
DA-12018
Acronym
SATURN
Status last verified
Mar 2007
First submitted
23 Mar 2007
Last updated
11 Jan 2017
Results posted
No
Data monitoring committee
No

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.

    PubMed 12507797
  • 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.

    PubMed 17950161

Questions about this trial

What is this clinical trial studying?

A study testing Random, no advanced notice drug and alcohol testing in people with Drug Abuse and Alcohol Abuse, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00451854, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.

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