Screening Protocol for the Evaluation of Research Participants

Substance Abuse Clinical Trial

Official title:

Evaluation of Potential Research Subjects - Screening Protocol for Clinical Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01036217
• Other study ID #: 999906412
• Secondary ID: 06-DA-N412
• Status: Completed
• Phase: N/A
• First received: December 18, 2009
• Last updated: June 30, 2017
• Start date: May 17, 2006
• Est. completion date: June 17, 2010

Study information

• Verified date: June 17, 2010
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55000
• Est. completion date: June 17, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Disorders
• Substance Abuse
• Substance-Related Disorders

Locations

Country	Name	City	State
United States	National Institute on Drug Abuse, Biomedical Research Center (BRC)	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States,