Clinical trial NCT01010620: Screening Protocol for Research Participants
Official title: Screening Protocol for the Evaluation of Research Participants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Substance Abuse
Cocaine Abuse
Tobacco Use Disorder
Keywords: screening
research participation
substance abuse
Schizophrenia
nicotine
Healthy
cigarettes
smoking
marijuana
cocaine
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2009-11-10
Enrollment: 523
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Recruitment of participants into NIDA/MPRC protocols.
timeFrame: 5 years
Secondary outcomes:
measure: Demographic characterization of drug users, non-users, and individuals with serious mental illnesses contacting NIDA/MPRC about research participation
timeFrame: 5 year
Other outcomes:
Locations:
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Deanna L Kelly, Pharm.D., BCPP
role: PRINCIPAL_INVESTIGATOR
References: