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Screening Protocol for the Evaluation of Research Participants

30. juni 2017 opdateret af: National Institute on Drug Abuse (NIDA)

Evaluation of Potential Research Subjects - Screening Protocol for Clinical Studies

Background:

- The National Institute on Drug Abuse (NIDA) uses a standardized set of procedures to develop a pool of potential participants for research studies. Because some of the data collected during screening are used later for research, the screening itself is considered a study. An applicant to any NIDA study is considered a participant in NIDA screening.

Objectives:

- To identify, recruit, and screen participants for NIDA research protocols.

Eligibility:

- Individuals 18 years of age and older who are able to provide informed consent.

Design:

  • Individuals who are eligible for screening will undergo two interviews: a telephone interview and an in-person interview. The phone interview will determine eligibility for the in-person interview.
  • The in-person interview may require up to five visits to NIDA. 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 screening, a photograph will be taken for confirmation of identity during subsequent visits for other studies.
  • No clinical care will be provided as part of screening.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Through its clinical research protocols, the NIDA 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 NIDA IRP 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 NIDA's 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

55000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21224
        • National Institute on Drug Abuse, Biomedical Research Center (BRC)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • INCLUSION CRITERIA:

    1. Adults (at least age 18)
    2. Ability to understand and answer the questions as posed.

EXCLUSION CRITERIA:

1. Inability to provide valid informed consent.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tidsperspektiver: Fremadrettet

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

17. maj 2006

Studieafslutning

17. juni 2010

Datoer for studieregistrering

Først indsendt

18. december 2009

Først indsendt, der opfyldte QC-kriterier

18. december 2009

Først opslået (Skøn)

21. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2017

Sidst verificeret

17. juni 2010

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 999906412
  • 06-DA-N412

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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