Screening Protocol for Research Participants

Schizophrenia Clinical Trial

— ScreenProt  

Official title:

Screening Protocol for the Evaluation of Research Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010620
• Other study ID #: HP-00043664
• Secondary ID: MPRC #412NIDA #4
• Status: Completed
• Start date: December 2009
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cocaine Abuse
• Cocaine-Related Disorders
• Schizophrenia
• Substance Abuse
• Substance-Related Disorders
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Maryland Psychiatric Research Center	Catonsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment of participants into NIDA/MPRC protocols.		5 years
Secondary	Demographic characterization of drug users, non-users, and individuals with serious mental illnesses contacting NIDA/MPRC about research participation		5 year

External Links

•   Recruitment Website