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Screening Protocol for Research Participants (ScreenProt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01010620
Recruitment Status : Recruiting
First Posted : November 10, 2009
Last Update Posted : May 16, 2018
Information provided by (Responsible Party):
MPRC, University of Maryland

Brief Summary:
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 or disease Intervention/treatment
Schizophrenia Substance Abuse Cocaine Abuse Tobacco Use Disorder Behavioral: Various Screening psychiatric and medical assessments

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Screening Protocol for the Evaluation of Research Participants
Study Start Date : December 2009
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Recruitment of participants into NIDA/MPRC protocols. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Demographic characterization of drug users, non-users, and individuals with serious mental illnesses contacting NIDA/MPRC about research participation [ Time Frame: 5 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01010620

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Contact: Christopher Kitchen 410-402-6425

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United States, Maryland
Maryland Psychiatric Research Center Recruiting
Catonsville, Maryland, United States, 21228
Contact: Christopher Kitchen    410-402-6425   
Contact: Stephanie Feldman, LCSW-C    410-402-6885   
Principal Investigator: Deanna L Kelly, Pharm.D., BCPP         
Sponsors and Collaborators
University of Maryland
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Principal Investigator: Deanna L Kelly, Pharm.D., BCPP University of Maryland

Additional Information:
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Responsible Party: MPRC, Kimberly Warren, PhD, University of Maryland Identifier: NCT01010620     History of Changes
Other Study ID Numbers: HP-00043664
MPRC #412
NIDA #444
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Keywords provided by MPRC, University of Maryland:
research participation
substance abuse

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