SchizophreniaScreenProtNCT01010620
Screening Protocol for Research Participants
An observational study of Schizophrenia and Substance Abuse, run by University of Maryland, Baltimore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Substance Abuse, Cocaine Abuse
- What is being tested?
- Various Screening psychiatric and medical assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 523 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Age 18 or older
- Ability to read and understand and answer questions posed.
Who cannot join
- Inability to provide valid informed consent
- Below Age 18, and above age 64.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
Official title: 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.
Read the 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
- Being tested
- Various Screening psychiatric and medical assessments
- Keywords
- screening, research participation, substance abuse, Schizophrenia, nicotine, Healthy, cigarettes, smoking, marijuana, cocaine
- Medical subject headings
- Schizophrenia, Substance-Related Disorders, Cocaine-Related Disorders, Tobacco Use Disorder, Smoking, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Various Screening psychiatric and medical assessmentsBehavioural
Possibly blood draws, urine samples, toxicology screens, computer-based and written psychological, psychiatric, and behavioral questionnaires and assessments.
| Study group | Role | What they receive |
|---|---|---|
| Screening | Screening Assessment battery. Specific to study(or studies) the individual is screening for. Receives: Behavioral: Various Screening psychiatric and medical assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment of participants into NIDA/MPRC protocols.
Measured: 5 years
Secondary outcomes (1)
Demographic characterization of drug users, non-users, and individuals with serious mental illnesses contacting NIDA/MPRC about research participation
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startDec 2009
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
- Investigators
- Deanna L Kelly, Pharm.D., BCPP, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010620
- Sponsor's protocol ID
- HP-00043664
- Other IDs
- MPRC #412, NIDA #444
- Acronym
- ScreenProt
- Status last verified
- Aug 2019
- First submitted
- 8 Jul 2009
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Protocol for the Evaluation of Research Participants
- ClinicalTrials.gov ID
- NCT01010620
- Acronym / sponsor ID
- ScreenProt / HP-00043664
- Conditions
- Schizophrenia, Substance Abuse, Cocaine Abuse, Tobacco Use Disorder
- Keywords
- screening, research participation, substance abuse, Schizophrenia, nicotine, Healthy, cigarettes, smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Dec 2009 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | – | Behavioral: Various Screening psychiatric and medical assessmentsScreening Assessment battery. Specific to study(or studies) the individual is screening for. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Age 18 or older
- Ability to read and understand and answer questions posed.
Key exclusion criteria (2 listed)
- Inability to provide valid informed consent
- Below Age 18, and above age 64.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Various Screening psychiatric and medical assessmentsPossibly blood draws, urine samples, toxicology screens, computer-based and written psychological, psychiatric, and behavioral questionnaires and assessments. | Behavioural | Screening |
Primary outcome
Recruitment of participants into NIDA/MPRC protocols.
Time frame: 5 years
1 secondary outcome
Demographic characterization of drug users, non-users, and individuals with serious mental illnesses contacting NIDA/MPRC about research participation
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna L Kelly, Pharm.D., BCPP principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Substance Abuse, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment of participants into NIDA/MPRC protocols. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.