Screening Protocol for Research Participants

NCT ID: NCT01010620

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 523 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2019-06-01

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.

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.

Conditions

Schizophrenia; Substance Abuse; Cocaine Abuse; Tobacco Use Disorder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Screening

Screening Assessment battery. Specific to study(or studies) the individual is screening for.

Various Screening psychiatric and medical assessments

Intervention Type: BEHAVIORAL

Possibly blood draws, urine samples, toxicology screens, computer-based and written psychological, psychiatric, and behavioral questionnaires and assessments.

Interventions

Various Screening psychiatric and medical assessments

Possibly blood draws, urine samples, toxicology screens, computer-based and written psychological, psychiatric, and behavioral questionnaires and assessments.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

MPRC

Deanna L. Kelly, PharmD., BCPP Professor of Psychiatry Director, Treatment Research Program (TRP)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deanna L Kelly, Pharm.D., BCPP

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Locations

Maryland Psychiatric Research Center

Catonsville, Maryland, United States

Countries

United States

Other Identifiers

MPRC #412

Identifier Type: -

Identifier Source: secondary_id

NIDA #444

Identifier Type: -

Identifier Source: secondary_id

HP-00043664

Identifier Type: -

Identifier Source: org_study_id