Screening Protocol for Research Participants (ScreenProt)

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Tobacco Use Disorder; Substance Abuse; Cocaine Abuse
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 523

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Catonsville, Maryland, United States, 21228
      • Maryland Psychiatric Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recruitment of participants into NIDA/MPRC protocols.	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Demographic characterization of drug users, non-users, and individuals with serious mental illnesses contacting NIDA/MPRC about research participation	5 year

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Deanna L Kelly, Pharm.D., BCPP, University of Maryland, College Park

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: November 9, 2009
• First Posted (Estimate): November 10, 2009

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Schizophrenia; Healthy; substance abuse; smoking; screening; nicotine; marijuana; cocaine; cigarettes; research participation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Substance-Related Disorders; Schizophrenia; Tobacco Use Disorder; Cocaine-Related Disorders
• Other Study ID Numbers: HP-00043664; MPRC #412; NIDA #444