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.|
|ClinicalTrials.gov Identifier: NCT01010620|
Recruitment Status : Recruiting
First Posted : November 10, 2009
Last Update Posted : May 16, 2017
|Condition or disease||Intervention/treatment|
|Schizophrenia Substance Abuse Cocaine Abuse Tobacco Use Disorder||Behavioral: Various Screening psychiatric and medical assessments|
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|
|Estimated Enrollment :||5000 participants|
|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|
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.
- Recruitment of participants into NIDA/MPRC protocols. [ Time Frame: 5 years ]
- Demographic characterization of drug users, non-users, and individuals with serious mental illnesses contacting NIDA/MPRC about research participation [ Time Frame: 5 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010620
|Contact: Christopher Kitchenemail@example.com|
|United States, Maryland|
|Maryland Psychiatric Research Center||Recruiting|
|Catonsville, Maryland, United States, 21228|
|Contact: Christopher Kitchen 410-402-6425 firstname.lastname@example.org|
|Contact: Stephanie Feldman, LCSW-C 410-402-6885 email@example.com|
|Principal Investigator: Deanna L Kelly, Pharm.D., BCPP|
|Principal Investigator:||Deanna L Kelly, Pharm.D., BCPP||University of Maryland|