Screening Protocol for the Evaluation of Research Participants

Sponsor
National Institute on Drug Abuse (NIDA) (NIH)
Overall Status
Completed
CT.gov ID
NCT01036217
Collaborator
(none)
55,000
1
49
1122

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    55000 participants
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Potential Research Subjects - Screening Protocol for Clinical Studies
    Study Start Date :
    May 17, 2006
    Study Completion Date :
    Jun 17, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      • 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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Institute on Drug Abuse, Biomedical Research Center (BRC) Baltimore Maryland United States 21224

      Sponsors and Collaborators

      • National Institute on Drug Abuse (NIDA)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01036217
      Other Study ID Numbers:
      • 999906412
      • 06-DA-N412
      First Posted:
      Dec 21, 2009
      Last Update Posted:
      Jul 2, 2017
      Last Verified:
      Jun 17, 2010
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Jul 2, 2017