Atomoxetine Effects in Humans
調査の概要
詳細な説明
This pilot study will examine the effects of a norepinephrine reuptake blocker, atomoxetine, on physiological and subjective responses to physical and psychological models of stress and oral amphetamine in healthy volunteers. The physical stress model will be the cold pressor test (CPT) and the psychological stress will be the paced auditory serial addition task (PASAT).
Our overall hypothesis is that atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine.
2. Research Design: Double-blind, placebo-controlled, within-groups, outpatient study.
3. Methodology: A total of 18 healthy volunteers will participate in this four-week, within-groups, double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After receiving medication or placebo for three days, subjects will have a 6-hour laboratory session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and subjective outcome measures will be obtained during the experimental sessions. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II.
4. Findings: Since our last renewal, a total of 16 subjects signed the consent form. Among those, 6 subjects did not return after signing the consent form. An additional 2 subjects were randomized but did not complete the study. One subjects started 3 times was randomized 3 times therefore counted three times in enrollment. Currently still enrolling subjects. (2/7/07)
Have completed this study with 10 subjects, study was published. This study has been entered twice.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
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:
- Female and males age 18 yrs to 45 yrs
- Current history of good health and normal ECG
- not pregnant , nor breast feeding
- using acceptable birth control methods
Exclusion Criteria:
- History of heart disease, hypertension, renal or hepatic diseases, glaucoma,hyperthyroidism,
- Current use of psychotropic medication
- Current dependence on alcohol or on drugs or treatments for drug or alcohol addiction within the past 5 years
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:クロスオーバー割り当て
- 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 |
---|---|
実験的:1
atomoxetine 40mg per day
|
atomoxetine 40mg per day or placebo For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II. |
プラセボコンパレーター:2
second arm is placebo, sugar pill
|
atomoxetine 40mg per day or placebo For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II. |
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 |
時間枠 |
---|---|
Atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine
時間枠:one year
|
one year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Mehmet Sofuoglu, M.D., Ph.D.、Yale University
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- MIRECC HIC 0605001441
- DPMC (その他の識別子:NIDA)
- K02DA021304 (米国 NIH グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。