- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07637669
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
Olfactory Function and Model-based Behavior in People Living With HIV and SUD
Background:
Human immunodeficiency virus (HIV) infection can affect areas of the brain that control thinking ability. These same areas of the brain also control the sense of smell. HIV infection is common in people with substance use disorder (SUD). SUD also affects thinking ability. Researchers want to learn more about the connection between the sense of smell and decision-making ability in people with HIV, SUD, or both.
Objective:
To test the sense of smell in people with HIV and/or SUD and how they make choices based on odors.
Eligibility:
People aged 18 to 65 years with any of these: (1) HIV, (2) SUD, (3) both HIV and SUD, or (4) neither SUD nor HIV.
Design:
Participants will have 2 visits. Each visit will last 3 to 5 hours.
In visit 1, participants will have a blood draw and a saliva swab. They will answer questions about their health, sleep habits, food intake, and substance use. They will have smell tests:
They will smell scented sticks and answer questions about them. They will be blindfolded for some tests.
They will perform tasks on a computer. They will look at pictures and smell pleasant food odors, such as chocolate cake or pizza. Smells will be delivered using a nasal mask. Their sniffing and breathing will be measured. They may also be exposed to odor-free air. They will eat food that corresponds to one of the food odors they smelled.
In visit 2, participants will do a saliva swab and a different computer task that involves odors. They will also have tests of their attention and memory. Participants may opt to have an imaging scan of the brain.
연구 개요
상세 설명
Study Description:
Cognitive impairments persist in people living with Human Immunodeficiency Virus (HIV) despite anti-retroviral therapy (ART). However, these impairments remain under-characterized and it is not clear whether they include deficits in model-based control of behavior. HIV is common in people with substance use disorder (SUD) but the combined impact of HIV and SUD on cognition remains unclear. The olfactory system is uniquely vulnerable to neurodegeneration and overlaps with brain regions involved in decision making. This study will investigate olfactory function and model-based behavior in people living with HIV and SUD, and relate these measures to biomarkers of neurodegeneration.
Objectives:
The primary objective of this protocol is to compare olfactory function and performance on behavioral tasks assessing model-based behavior between people living with and without HIV, and between people with and without SUD.
Secondary objectives of this protocol are to compare blood-based and MRI0-based biomarkers of neurodegeneration between people living with and without HIV, and between people with and without SUD.
Endpoints:
Primary:
- Olfactory function (Sniffin Sticks Threshold, Discrimination, and Identification tests)
- Behavior on tasks assessing model-based behavior (outcome devaluation and sensory preconditioning)
Secondary:
- Blood-based biomarker of neurodegeneration (Neurofilament Light Chain [NfL])
- MRI-based biomarker of neurodegeneration (Magnetic Resonance Imaging)
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: NIDA IRP Screening Team
- 전화번호: (800) 535-8254
- 이메일: researchstudies@nida.nih.gov
연구 연락처 백업
- 이름: Thorsten Kahnt, Ph.D.
- 전화번호: (667) 312-5175
- 이메일: thorsten.kahnt@nih.gov
연구 장소
-
-
Maryland
-
Baltimore, Maryland, 미국, 21224
- National Institute on Drug Abuse
-
연락하다:
- Thorsten Kahnt
- 전화번호: 667-312-5175
- 이메일: thorsten.kahnt@nih.gov
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
For all participants:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged 18-65 years old. Justification: prevalence of olfactory impairments increases with age; after age 53, the prevalence is 24.5 percent, increasing to 62.5 percent in people ages 80-97.
- Agreement to adhere to Lifestyle Considerations throughout study duration.
- Ability of subject to understand and the willingness to sign a written informed consent document.
For participants in the HIV+ and SUD+ and HIV+ and SUD- groups:
-HIV positive.
For participants in the HIV+ and SUD+ and HIV- & SUD+ groups:
-Substance Use Disorder (SUD) other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD).
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
For all participants:
- History of neurological illnesses or neurosurgery including but not limited to cerebrovascular accident, Parkinson disease, Alzheimer disease, Huntington disease, central nervous system (CNS) tumor, significant head trauma with sequelae, multiple sclerosis or other demyelinating diseases, epilepsy, movement disorders. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise data integrity.
- History of current (past 12 months) uncontrolled major DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD.
- Candidates who recently (12 hours prior to a study visit) used medications and/or substances that are psychoactive or otherwise affect alertness will have to pass a clinical assessment for intoxication on the day of the study visit. Based on participant preferences and MAI/PI judgment, participants who fail the clinical assessment for intoxication will either be withdrawn or rescheduled.
- History of clinically significant anaphylaxis, e.g., due to severe asthma or food and nonfood allergies (e.g., latex, detergents, soap, etc.). The MAI will retain discretion to exclude a participant based on this criterion.
- Uncorrected impairments in visual acuity.
- Non-English speaking. Justification: The data integrity of some of the behavioral tasks used in this study would be compromised as they have only been validated in English.
- Pregnancy.
- Any other condition that in the judgment of the investigators is incompatible with participation.
For participants in the HIV+ and SUD- and HIV- and SUD- groups:
- History of current (past 12 months) SUD, excluding tobacco use disorder.
- Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.
- Daily alcohol or drug use (excluding caffeine and nicotine) for at least 4 continuous weeks in the past 12 months.
For participants in the HIV- and SU+ and HIV- and SUD- groups:
-HIV positive.
For the Optional MRI Segment:
-Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
HIV- & SUD-
Individuals without HIV and without an SUD
|
|
HIV- & SUD+
Individuals without HIV and with an SUD
|
|
HIV+ & SUD-
Individuals with HIV and without an SUD
|
|
HIV+ & SUD+
Individuals with HIV and with an SUD
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Olfactory function
기간: Visit 1
|
Sniffin Sticks Threshold, Discrimination, and Identification tests
|
Visit 1
|
|
Model-based decision making
기간: Visit 1 & 2
|
Model-based decision making as assessed in an outcome devaluation task (visit 1) and sensory preconditioning task (visit 2)
|
Visit 1 & 2
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Neurofilament Light Chain
기간: Visit 1
|
Plasma levels of neurofilament light chain [NfL]
|
Visit 1
|
|
MRI
기간: Visit 2 (optional)
|
MRI-based biomarkers of neurodegeneration
|
Visit 2 (optional)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Thorsten Kahnt, Ph.D., National Institute on Drug Abuse (NIDA)
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 10002591
- 002591-DA
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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