Screening Protocol for Research Participants (ScreenProt)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Schizophrenia
Substance Abuse
Cocaine Abuse
Tobacco Use Disorder
Behavioral: Various Screening psychiatric and medical assessments

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Screening Protocol for the Evaluation of Research Participants

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Recruitment of participants into NIDA/MPRC protocols. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5000
Study Start Date: June 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Screening
Screening Assessment battery. Specific to study(or studies) the individual is screening for.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010620

Contacts
Contact: Heather A Raley, LCPC 443-631-8023 hraley@mprc.umaryland.edu

Locations
United States, Maryland
Maryland Psychiatric Research Center Recruiting
Catonsville, Maryland, United States, 21228
Contact: Heather A Raley, LCPC    443-631-8023    hraley@mprc.umaryland.edu   
Contact: Stephanie Feldman, LCSW-C    410-402-6885    sfeldman@mprc.umaryland.edu   
Principal Investigator: Kimberly Warren, PhD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Kimberly Warren, PhD University of Maryland
Principal Investigator: David Gorelick, Md, PhD National Institute on Drug Abuse (NIDA)
  More Information

Additional Information:
No publications provided

Responsible Party: MPRC, Kimberly Warren, PhD, University of Maryland
ClinicalTrials.gov Identifier: NCT01010620     History of Changes
Other Study ID Numbers: HP-00043664, MPRC #412, NIDA #444
Study First Received: July 8, 2009
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
screening
research participation
substance abuse
Schizophrenia
nicotine
Healthy
cigarettes
smoking
marijuana
cocaine

Additional relevant MeSH terms:
Cocaine-Related Disorders
Schizophrenia
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 01, 2014