Screening Protocol for the Evaluation of Research Participants at the Maryland Psychiatric Research Center (MPRC)
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2009 |
| End Date: | April 2012 |
Screening Protocol for the Evaluation of Research Participants at MPRC
Background:
- The National Institute of 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, drug abuse
and co-occurring psychiatric disorders, 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 individuals who may be eligible
for future research studies.
Objectives:
- To identify, recruit, and screen participants for NIDA collaborative 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.
- The in-person interview, which may require up to five visits to the clinical center,
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.
- Participants will provide a photograph for confirmation of identity for subsequent
visits and protocols.
- No clinical care will be provided under this protocol.
- The National Institute of 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, drug abuse
and co-occurring psychiatric disorders, 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 individuals who may be eligible
for future research studies.
Objectives:
- To identify, recruit, and screen participants for NIDA collaborative 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.
- The in-person interview, which may require up to five visits to the clinical center,
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.
- Participants will provide a photograph for confirmation of identity for subsequent
visits and protocols.
- No clinical care will be provided under this protocol.
The MPRC/NIDA collaborative research program attempts to: elucidate the nature of serious
mental illnesses, 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 this work, the scientific goal of this screening protocol is to
assess potential research participants' eligibility for 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 research 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 and issues of selection and sample bias in clinical research.
The screening process will be done in two stages, a telephone interview and an in-person
evaluation. The telephone interview will last approximately 20 minutes and be conducted
solely via the NIDA call center. Answers provided during the phone interview will indicate
whether a caller is eligible for in-person screening. Those who appear eligible will be
given an appointment at either NIDA or MPRC. This protocol pertains only to the in-person
participants at MPRC. Written informed consent will be obtained when the person arrives. The
screening process can involve up to 5 visits to MPRC.
mental illnesses, 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 this work, the scientific goal of this screening protocol is to
assess potential research participants' eligibility for 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 research 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 and issues of selection and sample bias in clinical research.
The screening process will be done in two stages, a telephone interview and an in-person
evaluation. The telephone interview will last approximately 20 minutes and be conducted
solely via the NIDA call center. Answers provided during the phone interview will indicate
whether a caller is eligible for in-person screening. Those who appear eligible will be
given an appointment at either NIDA or MPRC. This protocol pertains only to the in-person
participants at MPRC. Written informed consent will be obtained when the person arrives. The
screening process can involve up to 5 visits to MPRC.
- INCLUSION CRITERIA:
1. Adults (at least age 18)
2. Ability to understand and answer the questions posed
EXCLUSION CRITERIA:
1. Inability to provide valid informed consent
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