Screening Protocol for the Evaluation of Potential Research Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01036971|
Recruitment Status : Recruiting
First Posted : December 21, 2009
Last Update Posted : March 22, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
- 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 the NIDA/IRP. Through its clinical research protocols, the 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 IRP's 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 IRP's mission. Therefore, a secondary goal of this protocol is to obtain data that characterizes the population of subjects contacting the IRP 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 adults age >= 18. 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 will not be required.
|Study Type :||Observational|
|Estimated Enrollment :||7500 participants|
|Official Title:||Screening Protocol for the Evaluation of Potential Research Subjects|
|Actual Study Start Date :||August 23, 2006|
potential research subjects
- Screening for NIDA studies [ Time Frame: baseline ]Screening for NIDA studies
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- Males and females ages 18 or older.
- Phone screen: Subjects who are unable to understand or adequately answer questions posed in the phone screen.
- Phone screen and in-person screen: Subjects unable to provide informed consent.
- Pregnant women
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036971
|Contact: Shannon M Pfistner||(800) firstname.lastname@example.org|
|Contact: Lorenzo Leggio, M.D.||(240) email@example.com|
|United States, Maryland|
|National Institute on Drug Abuse, Biomedical Research Center (BRC)||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Shannon Pfistner 800-535-8254 firstname.lastname@example.org|
|Principal Investigator:||Lorenzo Leggio, M.D.||National Institute on Drug Abuse (NIDA)|
|Responsible Party:||National Institute on Drug Abuse (NIDA)|
|Other Study ID Numbers:||
|First Posted:||December 21, 2009 Key Record Dates|
|Last Update Posted:||March 22, 2023|
|Last Verified:||March 17, 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||.No plan depicted in protocol.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|