Human Laboratory Study of Varenicline for Alcohol Use Disorder
調査の概要
詳細な説明
This study is a double-blind, randomized, placebo-controlled, parallel group, two-site study designed to assess the effects of varenicline as compared with placebo on responses to in vivo alcohol cue exposure in the human laboratory setting. After signing informed consent, subjects will be screened for eligibility including medical history, physical examination, vital signs, electrocardiogram (ECG), drinking history by the timeline follow-back (TLFB) method, alcohol breathalyzer test, Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA), medication use, MINI neuropsychiatric interview, urine toxicology screen, clinical chemistry, response to cue reactivity, and Columbia Suicide Severity Rating Scale (CSSR-S). Women of child-bearting potential will have a pregnancy test. If eligible for the study, subjects will be randomized using a stratified permuted block randomization procedure in an approximate 1:1 ratio (targeting 24 subjects per group - 12 subjects per group per site) to receive either varenicline or placebo for 6 weeks. Any nicotine use versus no use (cigarettes, cigars, chewing tobacco, electronic cigarettes, etc.) in the week before randomization is the stratification variable.
Varenicline or matched placebo will be titrated over the first week of the study up the maintenance dose of 1 mg (active) or two capsules (placebo) taken orally BID for an additional 5 weeks. Subjects will be seen in the clinic at screening, at randomization and 6 other times during the study. A final follow-up telephone interview will occur during Week 9 (2 weeks after the end of study visit).
After the first two weeks and after five weeks of investigational product administration at Study Week 3 and Study Week 6, respectively, subjects will undergo a cue reactivity paradigm session (HLAB) including 4 individual visual analog scale (VAS) items assessing alcohol craving, 2 VAS items assessing emotional reactivity to picture stimuli, and 2 items assessing emotional manipulation. Immediately after the HLAB session, subjects will view each picture again and record the emotion felt using the Self-Manikin Assessment (SAM).
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Connecticut
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New Haven、Connecticut、アメリカ、06511
- Yale University School of Medicine
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Rhode Island
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Providence、Rhode Island、アメリカ、02912
- Brown University
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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:
To be eligible, the subject must:
- Be at least 21 years of age.
- Meet the DSM 5 criteria for alcohol use disorder of a least moderate severity (AUD-MS).
- Be seeking treatment for AUD and desire a reduction or cessation of drinking.
- Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:
- oral contraceptives,
- contraceptive sponge,
- patch,
- double barrier (diaphragm/spermicidal or condom/spermicidal),
- intrauterine contraceptive system,
- levonorgestrel implant,
- medroxyprogesterone acetate contraceptive injection,
- complete abstinence from sexual intercourse, and/or
- hormonal vaginal contraceptive ring.
- Be able to take oral medication and be willing to adhere to the medication regimen.
- Complete all assessments required at screening and baseline.
- Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing in the next 2 months.
- Not anticipate any significant problems with transportation arrangements or available time to travel to the study site over the next 2 months.
- Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
- And others.
Exclusion Criteria:
- Contact site for additional information
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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実験的：varenicline
1 mg BID (2 capsules BID)
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1 mg BID
他の名前：
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プラセボコンパレーター：Placebo
1 mg BID (2 capsules BID)
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1 mg BID
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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 |
|---|---|---|
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Cue-elicited Craving
時間枠：Study Week 3
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The primary outcome is cue-elicited alcohol craving, operationalized as the difference in Visual Analog Scale (VAS) craving for alcohol when exposed to an alcohol cue minus the VAS craving for alcohol when exposed to a water cue.
The VAS has a minimum value of 0 and maximum value of 20; higher scores indicate more craving (a worse outcome).
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Study Week 3
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent Heavy Drinking Days
時間枠：Weeks 3-6
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The percentage of heavy drinking days during the last month of treatment (weeks 3-6).
A heavy drinking day is defined as 4 or more drinks on a single day for females and 5 or more drinks on a single day for males.
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Weeks 3-6
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The Percentage of Subjects Abstinent During the Last Month of Treatment (Weeks 3-6).
時間枠：Weeks 3-6
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The percentage of subjects abstinent from alcohol during the last month of treatment (weeks 3-6).
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Weeks 3-6
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Cigarettes Smoked Per Week
時間枠：Weeks 3-6
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The number of cigarettes smoked per week during the last month of treatment (weeks 3-6) computed only among participants who were smokers at baseline (varenicline n=11; placebo n=11).
Note: cigarettes smoked per week outcome data was missing for two of the varenicline participants resulting in n=9 available for analysis.
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Weeks 3-6
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Penn Alcohol Craving Scale
時間枠：Study Weeks 3, 4, 5, 6 (assessed weekly during this period)
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Penn Alcohol Craving Scale (higher numbers are indicative of more craving for alcohol); min = 0, max = 30.
The measure was assessed at Study Weeks 3, 4, 5, and 6.
The reported outcome is the adjusted mean total score across weeks 3-6.
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Study Weeks 3, 4, 5, 6 (assessed weekly during this period)
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協力者と研究者
捜査官
- スタディディレクター：Raye Litten, PhD、National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 (見積もり)
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
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。
アルコール使用障害の臨床試験
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