Screening Protocol for the Evaluation of Potential Research Subjects

This study is currently recruiting participants.
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01036971
First received: December 18, 2009
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

Background:

- The Neuroimaging Research Branch of the National Institute on Drug Abuse (NIDA) is interested in developing a pool of potential research participants who may be eligible for research studies on drug abuse and addiction, pharmacological and psychosocial therapies for substance addiction, and the long-term effects of drugs on the development, function, and structure of the brain and other organ systems. To develop this pool of potential participants, researchers intend to screen adolescents and adults who may be eligible for future research studies.

Objectives:

- To identify, recruit, and screen participants for NIDA neuroimaging research protocols.

Eligibility:

- Individuals 13 years of age and older who are able to provide informed consent.

Design:

  • Eligible participants will undergo two screening interviews: a telephone interview and an in-person interview. The phone interview will determine eligibility for the in-person interview. Adolescents who are eligible for further screening must bring a parent or guardian with them to the in-person interview.
  • The in-person interview may require up to five visits to the NIDA clinical center. The in-person visit will involve any or all of the following procedures: (1) full physical examination and medical history; (2) psychiatric interview; (3) psychological testing; (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally invasive procedures as directed by the research staff.
  • During the screening process, participants will be explicitly asked for permission to recontact them after the 1-year duration of the screening protocol. For minors, both the adolescent and the parent/guardian must agree to future contact.
  • No clinical care will be provided under this protocol.

Condition
Evaluation

Study Type: Observational
Official Title: Screening Protocol for the Evaluation of Potential Research Subjects

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To identify, recruit and screen participants for NIDA IRP protocols.

Secondary Outcome Measures:
  • To be able to have the screening data obtained be shared across all IRB approved, NIDA-IRP protocols.

Estimated Enrollment: 5000
Study Start Date: May 2006
Detailed Description:

This protocol describes the screening process used by the National Institute on Drug Abuse (NIDA IRP) to assess potential research participants eligibility for entering protocols of the NIDA/IRP. Through its clinical research protocols, the NIDA IRP attempts to: elucidate the nature of drug abuse and addiction; determine the potential use of new therapies, both pharmacological and psychosocial; and decipher the long-term effects of drugs of abuse on the development, maturation, function, and structure of the brain and other organ systems. In support of the IRP s work, the scientific goal of this screening protocol is to assess potential research participants eligibility for the IRPs research studies. Screening will include medical and psychological tests and procedures. The data collected during screening are a unique and valuable source of information that aids in NIDA s mission. Therefore, a secondary goal of this protocol is to obtain data that characterizes the population of subjects contacting NIDA about research participation and to analyze data so obtained, such as that on the prevalence and consequences of HIV/AIDS, viral hepatitis, and related diseases. The population screened includes male and female adolescents ages 13-17 for NIDA only and adults age greater than or equal to 18 for both IRPs. Screening procedures include standard medical and psychological tests and procedures are minimal risk. There is no direct benefit to subjects. Participants are paid for undergoing the screening process.

Most genetics data will be collected under the aegis of protocol 10-DA-N457 and will be compared with data collected under this study. Some studies require genotyping to be done as part of screening. Those DNA samples will be stored so that if active or returning participants are screened for future studies requiring genotyping during screening an additional blood draw won t be required.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

    1. Males and females ages 13 or older.

EXCLUSION CRITERIA:

  1. Phone screen: subjects who are unable to understand or adequately answer questions posed in the phone screen.
  2. For phone screen and in person screen: Adult participants unable to provide informed consent.
  3. For phone screen and in person screen: Adolescents unable to provide assent for both telephone screening and in person screening and/or unable to have a parent/guardian able to provide informed consent for in person screening. Also, adolescents who are pregnant will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036971

Contacts
Contact: Agnes O Coffay, M.D. (443) 740-2399 coffaya@mail.nih.gov

Locations
United States, Maryland
National Institute on Drug Abuse, Biomedical Research Center (BRC) Recruiting
Baltimore, Maryland, United States, 21224
Contact: For more information contact Mathew's Media Group Recruiting    800-535-8254    researchstudies@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Agnes O Coffay, M.D. National Institute on Drug Abuse (NIDA)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01036971     History of Changes
Other Study ID Numbers: 999906415, 06-DA-N415
Study First Received: December 18, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Physical Examination
Medical Information
Assessment
Blood Work
Screening

ClinicalTrials.gov processed this record on April 16, 2014