Screening Protocol for the Evaluation of Potential Research Subjects
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/6/2019 |
| Start Date: | May 16, 2006 |
| Contact: | Karran A Phillips, M.D. |
| Email: | phillipsk@mail.nih.gov |
| Phone: | (443) 740-2298 |
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.
- 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
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.
(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.
- INCLUSION CRITERIA:
1. Males and females ages 18 or older.
EXCLUSION CRITERIA:
1. Phone screen: Subjects who are unable to understand or adequately answer questions
posed in the phone screen.
2. Phone screen and in person screen: Subjects unable to provide informed consent.
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Baltimore, Maryland 21224
Phone: 800-535-8254
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