덱사메타손은 알코올 갈망의 근간이 되는 스트레스 및 면역 체계 메커니즘을 표적으로 합니다.
알코올 사용 장애(AUD)가 있는 개인의 조기 금욕 동안 스트레스 및 면역 체계 변화를 목표로 하는 덱사메타손
This is a double-blind, placebo-controlled, proof of concept laboratory study to recruit N=70 (35 Males / 35 Females) non-treatment seeking, heavy drinkers with alcohol use disorder (AUD). It is hypothesized that randomization to 1.5mgs dexamethasone versus placebo will decrease alcohol craving during stress by decreasing basal cortisol, increasing anti-inflammatory cytokine levels and potentially normalizing the immune response to stress.
연구 개요
연구 유형
등록 (실제)
단계
- 초기 1단계
연락처 및 위치
연구 장소
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New York
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Stony Brook, New York, 미국, 11794
- The Health Sciences Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Non-treatment seeking heavy drinking men and women with AUD
- Age range 18-55,
- Body Mass Index (BMI) of 18-35
- Positive ethylglucuronide (EtG) urine toxicology screen for alcohol
- Able to provide informed written and verbal consent
- Able to read English and complete study evaluations
- Good health as verified by screening examination.
Exclusion Criteria:
- Meet criteria for Substance Use Disorder (SUD) or other psychoactive substances, excluding nicotine
- Unable to remain abstinent for five days
- Need for a medically assisted detoxification
- Regular use of steroids, anticonvulsants, sedatives/hypnotics, prescription analgesics, other anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, naltrexone, disulfiram, and any other psychoactive medications with the exception of stabilization on Selective Serotonin Re-uptake Inhibitors (SSRIs)
- Psychotic or severely psychiatrically disabled
- Significant underlying medical conditions which would be of potential harm
- Pregnancy or breast feeding women;
- Women using monophasic contraceptives
- Electrocardiogram (EKG) evidence of clinically significant conduction abnormalities, (Bazlett's corrected QT (QTc) interval of >450 msec for men and QTc>470 msec for women).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Guanfacine
single dose of dexamethasone (1.5mg) administered orally |
1.5mg oral dexamethasone to be administered once at 11:00PM
다른 이름들:
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위약 비교기: Placebo
single dose of placebo administered orally |
oral placebo to be administered once at 11:00PM |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Alcohol craving as assessed using subjective report following stress exposure
기간: Change from baseline to +5 minutes following stress exposure
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The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving |
Change from baseline to +5 minutes following stress exposure
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Alcohol craving as assessed using subjective report following stress exposure
기간: Change from baseline to +15 minutes following stress exposure
|
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving |
Change from baseline to +15 minutes following stress exposure
|
|
Alcohol craving as assessed using subjective report following stress exposure
기간: Change from baseline to +30 minutes following stress exposure
|
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving |
Change from baseline to +30 minutes following stress exposure
|
|
Alcohol craving as assessed using subjective report following stress exposure
기간: Change from baseline to +5 minutes following stress exposure
|
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely) |
Change from baseline to +5 minutes following stress exposure
|
|
Alcohol craving as assessed using subjective report following stress exposure
기간: Change from baseline to +15 minutes following stress exposure
|
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely) |
Change from baseline to +15 minutes following stress exposure
|
|
Alcohol craving as assessed using subjective report following stress exposure
기간: Change from baseline to +30 minutes following stress exposure
|
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely) |
Change from baseline to +30 minutes following stress exposure
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Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol
기간: Change from baseline to +5 minutes following stress exposure
|
4mls of plasma cortisol will be collected following exposure to stress |
Change from baseline to +5 minutes following stress exposure
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HPA axis response to stress exposure as assessed by cortisol
기간: Change from baseline to +15 minutes following stress exposure
|
4mls of plasma cortisol will be collected following exposure to stress |
Change from baseline to +15 minutes following stress exposure
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HPA axis response to stress exposure as assessed by cortisol
기간: Change from baseline to +30 minutes following stress exposure
|
4mls of plasma cortisol will be collected following exposure to stress |
Change from baseline to +30 minutes following stress exposure
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HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
기간: Change from baseline to +5 minutes following stress exposure
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4mls of plasma ACTH will be collected following exposure to stress |
Change from baseline to +5 minutes following stress exposure
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HPA axis response to stress exposure as assessed by ACTH
기간: Change from baseline to +15 minutes following stress exposure
|
4mls of plasma ACTH will be collected following exposure to stress |
Change from baseline to +15 minutes following stress exposure
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HPA axis response to stress exposure as assessed by ACTH
기간: Change from baseline to +30 minutes following stress exposure
|
4mls of plasma ACTH will be collected following exposure to stress |
Change from baseline to +30 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +5 minutes following stress exposure
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4mls of plasma Interleukin (IL)-10 will be collected following exposure to stress |
Change from baseline to +5 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +15 minutes following stress exposure
|
4mls of plasma IL-10 will be collected following exposure to stress |
Change from baseline to +15 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +30 minutes following stress exposure
|
4mls of plasma IL-10 will be collected following exposure to stress |
Change from baseline to +30 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +5 minutes following stress exposure
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4mls of plasma Interleukin 1 receptor antagonist (IL1-ra) will be collected following exposure to stress |
Change from baseline to +5 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +15 minutes following stress exposure
|
4mls of plasma IL1-ra will be collected following exposure to stress |
Change from baseline to +15 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +30 minutes following stress exposure
|
4mls of plasma IL1-ra will be collected following exposure to stress |
Change from baseline to +30 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +5 minutes following stress exposure
|
4mls of plasma IL-6 will be collected following exposure to stress |
Change from baseline to +5 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +15 minutes following stress exposure
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4mls of plasma IL-6 will be collected following exposure to stress |
Change from baseline to +15 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +30 minutes following stress exposure
|
4mls of plasma IL-6 will be collected following exposure to stress |
Change from baseline to +30 minutes following stress exposure
|
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +5 minutes following stress exposure
|
4mls of plasma Tumor Necrosis Factor alpha (TNFa) will be collected following exposure to stress |
Change from baseline to +5 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +15 minutes following stress exposure
|
4mls of plasma TNFa will be collected following exposure to stress |
Change from baseline to +15 minutes following stress exposure
|
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +30 minutes following stress exposure
|
4mls of plasma TNFa will be collected following exposure to stress |
Change from baseline to +30 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +5 minutes following stress exposure
|
4mls of plasma Tumor Necrosis Factor Receptor 1 (TNFR1) will be collected following exposure to stress |
Change from baseline to +5 minutes following stress exposure
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +15 minutes following stress exposure
|
4mls of plasma TNFR1 will be collected following exposure to stress |
Change from baseline to +15 minutes following stress exposure
|
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Immune system response to stress exposure as assessed by peripheral cytokines
기간: Change from baseline to +30 minutes following stress exposure
|
4mls of plasma TNFR1 will be collected following exposure to stress |
Change from baseline to +30 minutes following stress exposure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anxiety as assessed using subjective report following stress exposure
기간: Change from baseline to +5 minutes following stress exposure
|
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely) |
Change from baseline to +5 minutes following stress exposure
|
|
Anxiety as assessed using subjective report following stress exposure
기간: Change from baseline to +15 minutes following stress exposure
|
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely) |
Change from baseline to +15 minutes following stress exposure
|
|
Anxiety as assessed using subjective report following stress exposure
기간: Change from baseline to +30 minutes following stress exposure
|
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely) |
Change from baseline to +30 minutes following stress exposure
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Negative Mood as assessed using subjective report following stress exposure
기간: Change from baseline to +5 minutes following stress exposure
|
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely |
Change from baseline to +5 minutes following stress exposure
|
|
Negative Mood as assessed using subjective report following stress exposure
기간: Change from baseline to +15 minutes following stress exposure
|
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely |
Change from baseline to +15 minutes following stress exposure
|
|
Negative Mood as assessed using subjective report following stress exposure
기간: Change from baseline to +30 minutes following stress exposure
|
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely |
Change from baseline to +30 minutes following stress exposure
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Helen C Fox, PhD, Indiana University School of Medicine, Dept. of Psychiatry
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- R21AA029735 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .