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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 : March 22, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )

Study Description
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Brief 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 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.

Condition or disease
Addiction

Detailed 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 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 Design
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Study Type : Observational
Estimated Enrollment : 7500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Screening Protocol for the Evaluation of Potential Research Subjects
Actual Study Start Date : August 23, 2006
Groups and Cohorts
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Group/Cohort
1
potential research subjects


Outcome Measures
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Primary Outcome Measures :
  1. Screening for NIDA studies [ Time Frame: baseline ]
    Screening for NIDA studies


Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
Screening protocol for all NIDA clinical studies
Criteria

  • 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.
  3. Pregnant women
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Shannon M Pfistner (800) 535-8254 pfistners@nida.nih.gov
Contact: Lorenzo Leggio, M.D. (240) 478-1503 lorenzo.leggio@nih.gov

Locations
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United States, Maryland
National Institute on Drug Abuse, Biomedical Research Center (BRC) Recruiting
Baltimore, Maryland, United States, 21224
Contact: Shannon Pfistner    800-535-8254    pfistners@nida.nih.gov   
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Lorenzo Leggio, M.D. National Institute on Drug Abuse (NIDA)
More Information
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01036971    
Other Study ID Numbers: 999906415
06-DA-N415
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):
Physical Examination
Medical Information
Assessment
Blood Work
Screening
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior