Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01036971 |
| Other study ID # |
999906415 |
| Secondary ID |
06-DA-N415 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 23, 2006 |
Study information
| Verified date |
April 1, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
NIDA IRP Screening Team |
| Phone |
(800) 535-8254 |
| Email |
researchstudies[@]nida.nih.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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 18 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.
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 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 co-occurrence of pregnancy, 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 other protocols 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.
