Substance Use DisordersNCT01030835
Screening Protocol for the Evaluation of Research Participants at the Maryland Psychiatric Research Center (MPRC)
An observational study of Substance Use Disorders, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
Trial summary
Background: The National Institute of Drug Abuse (NIDA) is interested in developing a pool of potential research participants who may be eligible for research studies on drug abuse and addiction, pharmacological and psychosocial therapies for substance addiction, drug abuse and co-occurring psychiatric disorders, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- How many people
- 5,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 May 2009to 10 Apr 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (at least age 18)
- Ability to understand and answer the questions posed
Who cannot join
- 1. Inability to provide valid informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue
Catonsville, Maryland, 21228
About this study
Official title: Screening Protocol for the Evaluation of Research Participants at MPRC
Background:
- The National Institute of Drug Abuse (NIDA) is interested in developing a pool of potential research participants who may be eligible for research studies on drug abuse and addiction, pharmacological and psychosocial therapies for substance addiction, drug abuse and co-occurring psychiatric disorders, and the long-term effects of drugs on the development, function, and structure of the brain and other organ systems. To develop this pool of potential participants, researchers intend to screen individuals who may be eligible for future research studies.
Read more
Objectives:
- To identify, recruit, and screen participants for NIDA collaborative research protocols.
Eligibility:
- Individuals 18 years of age and older who are able to provide informed consent.
Design:
- Eligible participants will undergo two screening interviews: a telephone interview and an in-person interview. The phone interview will determine eligibility for the in-person interview.
- The in-person interview, which may require up to five visits to the clinical center, will involve any or all of the following procedures: (1) full physical examination and medical history; (2) psychiatric interview; (3) psychological testing; (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally invasive procedures as directed by the research staff.
- Participants will provide a photograph for confirmation of identity for subsequent visits and protocols.
- No clinical care will be provided under this protocol.
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
- Substance Use Disorders
- Keywords
- Screening Protocol, Comorbidity, Normal Controls, Substance Use Disorders, Substance Abuse Disorders
- Medical subject headings
- Substance-Related Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start28 May 2009
- Study completion10 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- David A Gorelick, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030835
- Sponsor's protocol ID
- 999909444
- Other IDs
- 09-DA-N444
- Status last verified
- 10 Apr 2012
- First submitted
- 11 Dec 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Protocol for the Evaluation of Research Participants at MPRC
- ClinicalTrials.gov ID
- NCT01030835
- Acronym / sponsor ID
- 999909444
- Conditions
- Substance Use Disorders
- Keywords
- Screening Protocol, Comorbidity, Normal Controls, Substance Use Disorders, Substance Abuse Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 28 May 2009
- Study completion
- 10 Apr 2012
- First posted
- 14 Dec 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.
Background:
- The National Institute of Drug Abuse (NIDA) is interested in developing a pool of potential research participants who may be eligible for research studies on drug abuse and addiction, pharmacological and psychosocial therapies for substance addiction, drug abuse and co-occurring psychiatric disorders, and the long-term effects of drugs on the development, function, and structure of the brain and other organ systems. To develop this pool of potential participants, researchers intend to screen individuals who may be eligible for future research studies.
Objectives:
- To identify, recruit, and screen participants for NIDA collaborative research protocols.
Eligibility:
- Individuals 18 years of age and older who are able to provide informed consent.
Design:
- Eligible participants will undergo two screening interviews: a telephone interview and an in-person interview. The phone interview will determine eligibility for the in-person interview.
- The in-person interview, which may require up to five visits to the clinical center, will involve any or all of the following procedures: (1) full physical examination and medical history; (2) psychiatric interview; (3) psychological testing; (4) electrocardiogram; (5) samples of blood, urine, and hair; and (6) other minimally invasive procedures as directed by the research staff.
- Participants will provide a photograph for confirmation of identity for subsequent visits and protocols.
- No clinical care will be provided under this protocol.
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
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (1 listed)
- 1. Inability to provide valid informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
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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.
David A Gorelick, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders, run by National Institute on Drug Abuse (NIDA) at 2 sites 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 1 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 2 Jul 2017.