Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552741
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Screening Evaluation and Assessment SEA Protocol at the NIDA IRP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Screening Evaluation and Assessment SEA Protocol at the NIDA IRP
Status:
RECRUITING
Status Verified Date:
2024-09-25
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
People who will participate in research studies need to undergo proper screening evaluation and assessment SEA SEA helps keep those who participate in studies safe It also helps ensure accurate study results The National Institute on Drug Abuse NIDA Intramural Research Program IRP wants to screen people with alcohol andor substance use disorders ASUD as well as people without ASUD for ongoing studies at NIDA in Baltimore MD
Objective
To screen people with or without ASUD for ongoing studies at NIDA The ultimate goals are to learn why some people 1 use drugs 2 stop using drugs 3 use drugs but do not get addicted and 4 never use drugs snd to develop ASUD treatments
Eligibility
People aged 18 years and older They may 1 currently use nicotine alcohol opioids cocaine or other drugs 2 no longer use them or 3 have never used them
Design
Participants will have 1 screening visit that could last up to 8 hours The visit may be split over more than 1 day The duration of the screening may vary for each individual based on which studies they are interested in and screened for The tests they undergo may vary and may include the following
Physical exam
Blood saliva and urine tests
Breath samples that test for alcohol and carbon monoxide
Test of heart function
Smell test that measures sense of smell
Tests of memory attention and thinking
Mental health evaluation
Mock magnetic resonance imaging MRI scan
Questionnaires about alcohol and other drug use mental health medical history and life in general
People who will participate in research studies need to undergo proper screening evaluation and assessment SEA SEA helps keep those who participate in studies safe It also helps ensure accurate study results The National Institute on Drug Abuse NIDA Intramural Research Program IRP wants to screen people with alcohol andor substance use disorders ASUD as well as people without ASUD for ongoing studies at NIDA in Baltimore MD
Objective
To screen people with or without ASUD for ongoing studies at NIDA The ultimate goals are to learn why some people 1 use drugs 2 stop using drugs 3 use drugs but do not get addicted and 4 never use drugs snd to develop ASUD treatments
Eligibility
People aged 18 years and older They may 1 currently use nicotine alcohol opioids cocaine or other drugs 2 no longer use them or 3 have never used them
Design
Participants will have 1 screening visit that could last up to 8 hours The visit may be split over more than 1 day The duration of the screening may vary for each individual based on which studies they are interested in and screened for The tests they undergo may vary and may include the following
Physical exam
Blood saliva and urine tests
Breath samples that test for alcohol and carbon monoxide
Test of heart function
Smell test that measures sense of smell
Tests of memory attention and thinking
Mental health evaluation
Mock magnetic resonance imaging MRI scan
Questionnaires about alcohol and other drug use mental health medical history and life in general
Detailed Description:
Study Description
This protocol describes the screening and evaluation process used by the National Institute on Drug Abuse NIDA Intramural Research Program IRP to assess eligibility of individuals interested in enrolling in other NIDA IRP clinical research protocols This protocol and clinical research protocols conducted at the NIDA IRP seek to improve understanding about of the nature of alcohol and Substance Use Disorders hereby referenced as SUD inclusive of alcohol use disorder determine the potential use of novel SUD therapies and establish the effects of SUD on the development maturation function and structure of the body s organ systems
Objectives
Primary Objective
-To provide an initial clinical and general evaluation of participants to assess eligibility for potential inclusion into other clinical research protocols at the NIDA IRP
Secondary Objectives
To use the data collected for the Primary Objective toward the development and execution of hypotheses-driven and hypotheses-generating analyses
To create a registry of participants that may be interested in and eligible to enrollre-enroll in NIDA IRP clinical research protocols
Endpoints
Primary Endpoint
-Screening evaluation and assessment for eligibility to participate in other NIDA clinical research protocols
Secondary Endpoints
-Use the data collected for the primary endpoint to conduct future research to further characterize and understand alcohol and drug use addiction abstinence and other outcomes in people with and without SUD
This protocol describes the screening and evaluation process used by the National Institute on Drug Abuse NIDA Intramural Research Program IRP to assess eligibility of individuals interested in enrolling in other NIDA IRP clinical research protocols This protocol and clinical research protocols conducted at the NIDA IRP seek to improve understanding about of the nature of alcohol and Substance Use Disorders hereby referenced as SUD inclusive of alcohol use disorder determine the potential use of novel SUD therapies and establish the effects of SUD on the development maturation function and structure of the body s organ systems
Objectives
Primary Objective
-To provide an initial clinical and general evaluation of participants to assess eligibility for potential inclusion into other clinical research protocols at the NIDA IRP
Secondary Objectives
To use the data collected for the Primary Objective toward the development and execution of hypotheses-driven and hypotheses-generating analyses
To create a registry of participants that may be interested in and eligible to enrollre-enroll in NIDA IRP clinical research protocols
Endpoints
Primary Endpoint
-Screening evaluation and assessment for eligibility to participate in other NIDA clinical research protocols
Secondary Endpoints
-Use the data collected for the primary endpoint to conduct future research to further characterize and understand alcohol and drug use addiction abstinence and other outcomes in people with and without SUD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None