Screening Protocol for the Evaluation of Potential Research Subjects
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|ClinicalTrials.gov Identifier: NCT01036971|
Recruitment Status : Recruiting
First Posted : December 21, 2009
Last Update Posted : May 9, 2018
- 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.
- To identify, recruit, and screen participants for NIDA neuroimaging research protocols.
- Individuals 13 years of age and older who are able to provide informed consent.
- 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 or disease|
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 either the NIDA/IRP. Through its clinical research protocols, the IRPs attempt 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 IRPs 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 the IRPs missions. Therefore, a secondary goal of this protocol is to obtain data that characterizes the population of subjects contacting the IRPs 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 > 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.
|Study Type :||Observational|
|Estimated Enrollment :||7500 participants|
|Official Title:||Screening Protocol for the Evaluation of Potential Research Subjects|
|Study Start Date :||May 16, 2006|
- To identify, recruit and screen participants for NIDA IRP protocols.
- To be able to have the screening data obtained be shared across all IRB approved, NIDA-IRP protocols.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036971
|Contact: Karran A Phillips, M.D.||(443) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Karran A Phillips, M.D.||National Institute on Drug Abuse (NIDA)|