HIV 患者のアルコール使用障害に対する適応外薬: パイロット研究 2 (HARP)
HIV 患者におけるアルコール使用障害に対する適応外薬の実現可能性、受容性、予備的有効性: 非盲検パイロット研究
This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.
調査の概要
詳細な説明
This is a series of three open-label pilot studies that consist of a 12-week intervention including off-label use of medication with MM and a clinical pharmacist-delivered behavioral intervention to treat AUD. Participants will receive counseling that incorporates brief feedback and advice with motivational enhancement techniques to assist the participant in changing their behaviors with respect to alcohol consumption and/or polypharmacy defined as taking five or more medications, particularly if those medications interact with alcohol. In addition, participants will be offered varenicline in the first pilot study. The rationale for utilizing an open-label pilot study design is to determine the feasibility, acceptability, safety, and preliminary efficacy of this intervention for the management of AUD. Participants will be interviewed with regards to their perspectives on feasibility and acceptability. They will be instructed to have medication bottles at study visits to assess medication adherence and will be assessed with readiness to change metrics and questions regarding quantity and frequency of alcohol use. Patients will also be asked to complete an AUDIT-C screen and the Alcohol Symptom Checklist at the start of the study period to screen for mild, moderate, or severe AUD. Several assessments including interviews and laboratory testing will be done at study visits.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Georgia
-
Decatur、Georgia、アメリカ、30033
- Atlanta VA Medical Center
-
-
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:
- diagnosed with HIV
- Receive care at the Atlanta VA Healthcare System
- Are age 18 or over
- Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen
- Have evidence of significant alcohol use: PEth > 20ng/ml
- Currently smoking cigarettes
- Prescribed >=5 medications
- Have cell phone or reliable contact number
- Can provide written informed consent
Exclusion Criteria:
- Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
- Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive
- Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment
- Untreated moderate to severe opioid use disorder
- Residence out of state
- Inability to read or understand English
- History of serious hypersensitivity or adverse reaction to study medication
- Taking potentially interactive medication(s) (e.g. nicotine replacement therapy for varenicline pilot study)
- Already prescribed the pilot medication at the time of study recruitment
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：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：Varenicline
Participants will receive a prescription for generic varenicline |
All participants will receive a prescription for varenicline and will meet with a clinical pharmacist and addiction psychiatrist for further support |
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 |
|---|---|---|
|
Proportion of participants who complete enrollment and duration of sessions
時間枠：12 weeks
|
Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study |
12 weeks
|
|
Number of sessions completed
時間枠：12 weeks
|
Number of sessions completed to assess acceptability of study |
12 weeks
|
|
Adherence to Medication
時間枠：12 weeks
|
Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study |
12 weeks
|
|
Safety of study assessed by adverse events reporting
時間枠：12 weeks
|
Safety will be assessed by the percentage of study participants who report adverse events |
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Efficacy of study - change in self-reported alcohol use
時間枠：12 weeks
|
Change in self-reported alcohol use (# of days of alcohol use and # of drinks per day) on the Timeline Followback. |
12 weeks
|
|
Efficacy of study - change in PEth (phosphatidylethanol) results
時間枠：12 weeks
|
PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels. |
12 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：E. Jennifer Edelman, MD, MHS、Yale University
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
- 2000033919_b
- 1P01AA029545-01 (米国 NIH グラント/契約)
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。
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。