Imaging Mitochondrial Complex-I in Alcohol Use Disorder
Imaging Mitochondrial Complex-I With [F-18]BCPP-EF Positron Emission Tomography (PET) in Alcohol Use Disorder (AUD)
Studies proposed in this application will image mitochondrial Complex-I (MCI-I) and cerebral glucose metabolism (CGM) in alcohol use disorder (AUD) and matched healthy controls
調査の概要
詳細な説明
This study uses [18F]BCPP-EF and [18F]FDG positron emission tomography (PET) to image mitochondrial complex I and cerebral glucose metabolism (CGM) in subjects with alcohol use disorder (AUD) and healthy controls (HC). Correlating PET outcome measures with relapse to alcohol in this study will clarify the mechanisms by which abnormal brain energetics modulate addictive behaviors.
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前:Rajesh Narendran
- 電話番号:412-647-5176
- メール:narendranr@upmc.edu
研究場所
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、アメリカ、15213
- 募集
- University of PIttsburgh
-
コンタクト:
- Principal Investigator
- 電話番号:412-647-5176
- メール:narendranr@upmc.edu
-
-
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
Alcohol use disorders (AUD)
- Males or females between 18 and 55 years old
- fulfill DSM-5 criteria for alcohol use disorder
- History of NIAAA heavy drinking (for males, routinely consuming more than 4 drinks on any day or more than 14 drinks per week; for females, routinely consuming more than 3 drinks on any day or more than 7 drinks per week) in the past 30 days
- No other major DSM-5 psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, developmental disorders, or current depressive disorders (unless they are related to alcohol intoxication, withdrawal, or an alcohol- induced mood disorder).
- No other DSM-5 substance use disorders including opioids, cocaine, amphetamines, sedative-hypnotics, hallucinogens, and inhalants. Subjects with moderate and severe DSM-5 cannabis and tobacco use disorder will also be excluded;
- Subjects not currently on psychotropic or medical medications that can influence binding to MC-I (e.g., metformin) or CGM (e.g., insulin, GLP-1 agonists), or increase the risks associated with an arterial line (e.g., warfarin, clopidogrel, aspirin, naproxen, ibuprofen, etc.).
- No medical disorders that can influence the PET outcome measures (for example, MC-I binding is altered in Parkinson's disease, mild or major neurocognitive disorders, and mitochondrial disorders; CGM is altered in diabetes, severe hyperlipidemia, hypertension, obesity), increase the risks associated with blood sampling (anemia), or placement of an arterial line (history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis) for PET
- Not currently pregnant or breast-feeding
- Not currently employed as a radiation worker; or has participated in a radiation-related research protocol within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous radioactive drug study [studies] and this study) would exceed the radiation dose limits specified in the FDA regulations (i.e., 21 CFR 361.1) that govern the research use of radiotracers
- No medical or psychiatric contraindications to undergo an MRI scan (such as ferromagnetic tattoos/piercings, implants, medical equipment, history of gunshot, and claustrophobia).
Healthy controls (HC)
- Males or females between 18 and 55 years old
- No current or past DSM-5 psychiatric or substance use disorders other than tobacco use disorder
- No history of heavy drinking as defined using NIAAA criteria in the past year
- 5 to 10 above.
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:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:PET
Positron Emission Tomography Scans |
Radiotracer to measure binding to mitochondria complex -I Radiotracer to measure cerebral glucose metabolism |
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 |
|---|---|---|
|
Dorsolateral prefrontal cortex [F-18]BCPP-EF VT
時間枠:Baseline scan (time 0)
|
VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3 |
Baseline scan (time 0)
|
|
Orbitofrontal cortex [F-18]BCPP-EF VT
時間枠:Baseline scan (time 0)
|
VT is the volume of distribution expressed relative to total plasma radioligand concentration in mL/cm3 |
Baseline scan (time 0)
|
|
Medial Prefrontal Cortex [F-18]BCPP-EF VT
時間枠:Baseline scan (time 0)
|
VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3 |
Baseline scan (time 0)
|
|
Dorsolateral prefrontal cortex [F-18]FDG SUVR
時間枠:Baseline scan (time 0)
|
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless |
Baseline scan (time 0)
|
|
Orbitofrontal cortex [F-18]FDG SUVR
時間枠:Baseline scan (time 0)
|
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless |
Baseline scan (time 0)
|
|
Medial Prefrontal Cortex [F-18]FDG SUVR
時間枠:Baseline scan (time 0)
|
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless |
Baseline scan (time 0)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Relapse to alcohol severity measure
時間枠:during 8-week follow up
|
Total number of ETG-negative urines (0 to 16) |
during 8-week follow up
|
|
Penn Alcohol Craving Scale (PACS)
時間枠:during 8-week follow up
|
Mean weekly PACS scores (range 0 to 30; higher scores indicate more craving) |
during 8-week follow up
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Categorical relapse to alcohol
時間枠:8-week follow up
|
Abstained v Relapsed v Drop-out |
8-week follow up
|
|
TIme to relapse
時間枠:during 8 week follow up
|
in weeks (0 to 8) |
during 8 week follow up
|
|
Perceived Stress Scale (PSS)
時間枠:during 8-week follow up
|
Mean weekly PSS scores (0 to 40; higher scores indicate more stress) |
during 8-week follow up
|
|
Prefrontal Cortical Thickness
時間枠:Baseline scan (time 0)
|
MRI-derived cortical thickness measure derived using FreeSurfer, in mm |
Baseline scan (time 0)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Rajesh Narendran, MD、University of Pittsburgh
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
キーワード
その他の研究ID番号
- STUDY24030081
- R01AA031453-01A1 (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?
IPD プランの説明
All individual participant data that underlie the results reported in the publication or upon study completion will be shared after de-identification via NIAAA Data Archive
IPD 共有時間枠
Upon publication or study completion Data will be available as long as it is archived as per NIAAA Data Archive policy
IPD 共有アクセス基準
Aavailable as per NIAAA Data Archive policy
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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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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