- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05707806
학습 및 의사 결정 작업의 개발 및 검증
Background:
Substance use disorders (SUD) can be considered disorders in the way people process incentives, learn, and make decisions. To understand why some people develop SUD, researchers need to develop reliable tests that show how people think and learn. This natural history study seeks to develop a set of tasks that could then be used to test how people learn and make decisions.
Objective:
To develop and validate behavioral tasks that could be used in future studies.
Eligibility:
Healthy people aged 18-45 years from the Baltimore area. They must also be enrolled in the NIDA screening protocol.
Design:
Participants will perform different tasks. Most tasks require 1-4 study visits; some may require up to 12. Visits are 1-14 days apart. All visits will last about 1-7 hours.
Participants will perform tasks on a computer. As they work they may be given different stimuli:
Smells. Participants will sniff odors through a plastic tube or mask on their nose.
Flavors. Participants will wear a mouthpiece and small amounts of different flavored liquids will be placed in their mouth.
Pictures. Participants will look at different images.
Sounds. Participants will wear headphones and various sounds will be played for them.
Food. Participants may be asked to eat a meal before, during, or after a task. The researchers will provide the meal.
During each task, participants will wear sensors to monitor their heart rate, blood pressure, breathing, and other physical changes in their bodies.
Some participants will have a functional magnetic resonance imaging (fMRI) scan. They will lie on a table that slides into a cylinder. They will perform tasks on a computer screen during the fMRI.
연구 개요
상세 설명
Study Description:
From a behavioral perspective, substance-use disorders (SUD) can be considered as disorders of incentive processing, learning, and decision-making. The Learning and Decision-Making Unit at NIDA IRP conducts Basic Experimental Studies involving Humans (BESH) to study the neurocomputational mechanisms underlying these functions, and their disruption in SUD. For this, behavioral tasks suitable for use both in and outside the functional magnetic resonance imaging (fMRI) scanner need to be developed and validated.
Objectives:
The primary objective of this protocol is to develop and validate behavioral tasks inside and outside the fMRI scanner, and to determine their practical feasibility for future studies.
Endpoints:
The primary endpoint is to determine if the developed tasks reliably and appropriately measure specific cognitive functions, and if they yield measurable and interpretable fMRI results in the associated brain systems.
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
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Maryland
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Baltimore, Maryland, 미국, 21224
- 모병
- National Institute on Drug Abuse
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연락하다:
- Thorsten Kahnt
- 전화번호: 667-312-5175
- 이메일: thorsten.kahnt@nih.gov
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
local community sample: metropolitan Baltimore area
설명
- INCLUSION CRITERIA:
There are two levels of inclusion and exclusion criteria; those applying to all participants and those applying to participants in the 'MRI' phase only. Participants will be cleared for both the behavioral and MRI phases, if eligible, and will be invited to sign one or both consents depending on what tasks are active at the time of consent. If a person is not MRI compatible, they will only be offered enrollment into the behavioral phase of the study.
In order to be eligible to participate in this study, an individual must meet the following criteria:
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Male or female, aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals.
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In good general health.
In order to be eligible to participate in the MRI phase of this study, an individual must - in addition - also meet all of the following criteria:
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Right-handed.
EXCLUSION CRITERIA:
Individuals who meet any of the following criteria will be excluded from participation:
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History of neurological illnesses or neurosurgery including but not limited to cerebrovascular accident, Parkinson disease, Alzheimer disease, Huntington disease, 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.
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History of currently unresolved psychiatric disorders with current (past 12 months) regular use of psychiatric medications. Past/remitted (>12 months ago) psychiatric disorders with no currently active symptoms and no current use of psychiatric medications may be included in the study, per MAI discretion.
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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.
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Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks in the past 12 months.
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Current use of psychoactive medications and medications that affect alertness and that cannot (in principle) be withheld the night before the study visit. Participants who can withhold these medications will either (1) withhold the medication during this time or (2) not withhold the medication and pass a clinical assessment for intoxication on the day of the study visit. Based on participant preferences and MAI/PI judgement, participants who fail the clinical assessment for intoxication will either be withdrawn or rescheduled and asked to withhold the medication.
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For tasks that involve gustatory or olfactory stimuli, food intake: History of anaphylaxis, e.g., due to severe asthma or food and non-food allergies (e.g., latex, detergents, soap, etc.). This will disqualify participants for tasks that involve chemosensory stimuli or food intake, but not from the study itself.
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Uncorrected impairments in visual acuity.
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Non-English speaking. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.
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Pregnancy.
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Any other condition that in the judgment of the investigators is incompatible with participation.
An individual who meets any of the following criteria will be excluded from participation in the MRI phase of this study:
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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
- 관찰 모델: CASE_CONTROL
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
healthy controls
generally healthy volunteers |
Enables the use of custom pulse sequence |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
task performance
기간: each study visit
|
to determine if the developed tasks reliably and appropriately measure specific cognitive functions, and if they yield measurable and interpretable fMRI results in the associated brain systems. |
each study visit
|
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 (실제)
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
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
There is no plan to share raw data from the study as this is a study to develop and validate behavioral tasks, to determine if they can reliably and appropriately measure specific functions, and if they yield measurable and interpretable fMRI results in the associated brain systems.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .