Screening Protocol for the Evaluation of Potential Research Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
ClinicalTrials.gov Identifier:
NCT01036971
First received: December 18, 2009
Last updated: October 16, 2014
Last verified: September 2014

December 18, 2009
October 16, 2014
May 2006
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To identify, recruit and screen participants for NIDA IRP protocols.
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Complete list of historical versions of study NCT01036971 on ClinicalTrials.gov Archive Site
To be able to have the screening data obtained be shared across all IRB approved, NIDA-IRP protocols.
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Screening Protocol for the Evaluation of Potential Research Subjects
Screening Protocol for the Evaluation of Potential Research Subjects

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.

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.

Observational
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Evaluation
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Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
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  • 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.
Both
13 Years and older
Yes
Contact: Agnes O Coffay, M.D. (443) 740-2399 coffaya@mail.nih.gov
Contact: Karran A Phillips, M.D. (443) 740-2298 phillipsk@mail.nih.gov
United States
 
NCT01036971
999906415, 06-DA-N415
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National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Karran A Phillips, M.D. National Institute on Drug Abuse (NIDA)
National Institutes of Health Clinical Center (CC)
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP