Substance Abuse DetectionNCT01037569
Optimizing Toxicological Screening in Drug Endangered Children
An observational study of Substance Abuse Detection, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Children who enter the foster care system are all too often exposed to illicit drugs in the home. Children from these homes, known as drug endangered children, are not routinely tested for harmful substances. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Substance Abuse Detection
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2007to 22 Mar 2011
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
- ELIGIBILITY CRITERIA:
Inclusion criteria are the following (and must have all of the following):
- children under the age of 18 (the vast majority - 87 percent - of children examined at the Center are under the age of 6);
- children placed into protective custody by Sacramento County CPS or law enforcement;
- children examined at the CAARE Center; and
- children found in a home where drugs are manufactured, used and/or sold.
Exclusion criteria are the following (any one of the following may apply):
- anyone who has reached the age of majority;
- those found to have parents who are not drug abusers;
- those where there was no definitive evidence of environmental drug exposure (i.e., suspicious parent, but no drugs were found in the home); or
- any child, drug exposed or not, who is examined in the UCD Emergency Department (after hours - 9:00 pm to 7:00 am - and weekends).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
Background:
- Children who enter the foster care system are all too often exposed to illicit drugs in the home. Children from these homes, known as drug endangered children, are not routinely tested for harmful substances. Any short- and long-term physical or developmental problems they may experience as a result of this exposure often go undetected and untreated.
- Children who are placed into protective custody are not always screened by physicians or nurse practitioners. Although drug-endangered children under 18 years of age automatically receive a urine toxicology screen to determine the types and levels of illicit drugs in their systems, this procedure has difficulties and limitations that may affect the quality of the data. Researchers are interested in developing more effective methods of analyzing the presence or absence of illicit environmental drug exposure in children.
Read more
Objectives:
- To determine the most effective method of identifying long-term illicit stimulant drug exposure in drug-endangered children.
Eligibility:
- Children under 18 years of age who are being placed into protective custody after having been found in a home where drugs are manufactured, used, or sold.
Design:
- Researchers will gain verbal consent for the procedure for children who are 7 years of age or older. Children younger than 7 years of age will not be required to give verbal consent for sample collection.
- Researchers will collect standard urine samples for toxicological screening. Part of the sample will be sent to the National Institute on Drug Abuse for evaluation; the rest will remain with the local authority.
- In addition to this standard procedure, researchers will collect a hair sample by cutting a small amount of hair from the crown of the head as close to the root as possible (and not pulling any hair out of the child's head).
- Researchers will also use an oral swab to collect a saliva sample from the inside cheek of each child.
- No clinical care will be provided under this protocol....
Read the detailed description
This is a single-center, investigator-initiated study to determine the best method for analyzing the presence or absence of illicit environmental drug exposure in children placed into protective custody in Sacramento County. In collaboration with the National Institutes of Health (NIH), National Institute of Drug Abuse (NIDA) we will use diagnostic procedures to determine the presence of illicit drugs in the following three samples: (1) hair; (2) oral swab; and (3) urine. These samples will be sent to a designated NIH lab site where 100 de-identified samples will be analyzed for methamphetamine, amphetamine, Ecstasy (MDMA), and MDEA.
- Conditions
- Substance Abuse Detection
- Keywords
- Toxicological Screening, Drugs, Alternative Matrices, Urine, Children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study start10 Jul 2007
- Study completion22 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037569
- Sponsor's protocol ID
- 999907431
- Other IDs
- 07-DA-N431
- Status last verified
- 22 Mar 2011
- First submitted
- 19 Dec 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Toxicological Screening in Drug Endangered Children
- ClinicalTrials.gov ID
- NCT01037569
- Acronym / sponsor ID
- 999907431
- Conditions
- Substance Abuse Detection
- Keywords
- Toxicological Screening, Drugs, Alternative Matrices, Urine, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 10 Jul 2007
- Study completion
- 22 Mar 2011
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Children who enter the foster care system are all too often exposed to illicit drugs in the home. Children from these homes, known as drug endangered children, are not routinely tested for harmful substances. Any short- and long-term physical or developmental problems they may experience as a result of this exposure often go undetected and untreated.
- Children who are placed into protective custody are not always screened by physicians or nurse practitioners. Although drug-endangered children under 18 years of age automatically receive a urine toxicology screen to determine the types and levels of illicit drugs in their systems, this procedure has difficulties and limitations that may affect the quality of the data. Researchers are interested in developing more effective methods of analyzing the presence or absence of illicit environmental drug exposure in children.
Objectives:
- To determine the most effective method of identifying long-term illicit stimulant drug exposure in drug-endangered children.
Eligibility:
- Children under 18 years of age who are being placed into protective custody after having been found in a home where drugs are manufactured, used, or sold.
Design:
- Researchers will gain verbal consent for the procedure for children who are 7 years of age or older. Children younger than 7 years of age will not be required to give verbal consent for sample collection.
- Researchers will collect standard urine samples for toxicological screening. Part of the sample will be sent to the National Institute on Drug Abuse for evaluation; the rest will remain with the local authority.
- In addition to this standard procedure, researchers will collect a hair sample by cutting a small amount of hair from the crown of the head as close to the root as possible (and not pulling any hair out of the child's head).
- Researchers will also use an oral swab to collect a saliva sample from the inside cheek of each child.
- No clinical care will be provided under this protocol....
Detailed description
This is a single-center, investigator-initiated study to determine the best method for analyzing the presence or absence of illicit environmental drug exposure in children placed into protective custody in Sacramento County. In collaboration with the National Institutes of Health (NIH), National Institute of Drug Abuse (NIDA) we will use diagnostic procedures to determine the presence of illicit drugs in the following three samples: (1) hair; (2) oral swab; and (3) urine. These samples will be sent to a designated NIH lab site where 100 de-identified samples will be analyzed for methamphetamine, amphetamine, Ecstasy (MDMA), and MDEA.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Abuse Detection, 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?
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 2 Jul 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.
Where can I read the original study information?
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 2 Jul 2017.