アルコール渇望の根底にあるストレスと免疫系のメカニズムを標的とするデキサメタゾン
デキサメタゾンは、アルコール使用障害 (AUD) を持つ個人の早期禁酒中のストレスおよび免疫系の変化を標的とする
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.
調査の概要
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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New York
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Stony Brook、New York、アメリカ、11794
- The Health Sciences Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Guanfacine
single dose of dexamethasone (1.5mg) administered orally |
1.5mg oral dexamethasone to be administered once at 11:00PM
他の名前：
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プラセボコンパレーター：Placebo
single dose of placebo administered orally |
oral placebo to be administered once at 11:00PM |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Alcohol craving as assessed using subjective report following stress exposure
時間枠：Change from baseline to +5 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 +5 minutes following stress exposure
|
|
Alcohol craving as assessed using subjective report following stress exposure
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
|
Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol
時間枠：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
|
|
HPA axis response to stress exposure as assessed by cortisol
時間枠：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
|
|
HPA axis response to stress exposure as assessed by cortisol
時間枠：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
|
|
HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
時間枠：Change from baseline to +5 minutes following stress exposure
|
4mls of plasma ACTH will be collected following exposure to stress |
Change from baseline to +5 minutes following stress exposure
|
|
HPA axis response to stress exposure as assessed by ACTH
時間枠：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
|
|
HPA axis response to stress exposure as assessed by ACTH
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：Change from baseline to +5 minutes following stress exposure
|
4mls of plasma Interleukin (IL)-10 will be collected following exposure to stress |
Change from baseline to +5 minutes following stress exposure
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：Change from baseline to +5 minutes following stress exposure
|
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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：Change from baseline to +15 minutes following stress exposure
|
4mls of plasma IL-6 will be collected following exposure to stress |
Change from baseline to +15 minutes following stress exposure
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
|
Immune system response to stress exposure as assessed by peripheral cytokines
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anxiety as assessed using subjective report following stress exposure
時間枠：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
時間枠：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
時間枠：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
|
|
Negative Mood as assessed using subjective report following stress exposure
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Helen C Fox, PhD、Indiana University School of Medicine, Dept. of Psychiatry
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- R21AA029735 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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