Screening Protocol for Research Participants (ScreenProt)

This study is currently recruiting participants.
Verified October 2013 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT01010620
First received: July 8, 2009
Last updated: October 22, 2013
Last verified: October 2013

July 8, 2009
October 22, 2013
June 2009
March 2014   (final data collection date for primary outcome measure)
Recruitment of participants into NIDA/MPRC protocols. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010620 on ClinicalTrials.gov Archive Site
Demographic characterization of drug users, non-users, and individuals with serious mental illnesses contacting NIDA/MPRC about research participation [ Time Frame: 5 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Screening Protocol for Research Participants
Screening Protocol for the Evaluation of Research Participants

The Screening Protocol is a system devised to evaluate potential research participants for National Institute on Drug Abuse/Maryland Psychiatric Research Center (NIDA/MPRC) studies.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Population will see an advertisement in the community and call the NIDA call center. If they appear to meet the qualifications for one or more NIDA/MPRC studies, they will be scheduled to be screened.

  • Schizophrenia
  • Substance Abuse
  • Cocaine Abuse
  • Tobacco Use Disorder
Behavioral: Various Screening psychiatric and medical assessments
Possibly blood draws, urine samples, toxicology screens, computer-based and written psychological, psychiatric, and behavioral questionnaires and assessments.
Other Name: N\A
Screening
Screening Assessment battery. Specific to study(or studies) the individual is screening for.
Intervention: Behavioral: Various Screening psychiatric and medical assessments
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 or older
  • Ability to read and understand and answer questions posed.

Exclusion Criteria:

  • Inability to provide valid informed consent
  • Below Age 18, and above age 64.
Both
18 Years to 64 Years
Yes
Contact: Heather A Raley, LCPC 443-631-8023 hraley@mprc.umaryland.edu
United States
 
NCT01010620
HP-00043664, MPRC #412, NIDA #444
No
MPRC, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Kimberly Warren, PhD University of Maryland
Principal Investigator: David Gorelick, Md, PhD National Institute on Drug Abuse (NIDA)
University of Maryland
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP