Medication and Counseling for Controlled Drinking (ProjectSMART)
Naltrexone and CBT for Problem-Drinking MSM
Problem drinking gay and bisexual men who try to quit drinking are at risk for relapse to heavy or problematic drinking because their social lives and social outlets are often strongly associated with alcohol. These men are most receptive to interventions focused on moderation of drinking rather than abstinence. However moderation-oriented cognitive-behavior therapy (CBT) and naltrexone (NTX) are both well established treatments for problem drinkers who wish to moderate, rather than stop, drinking. Research suggests that combining these treatments may enhance their efficacy.
This study combines moderation-oriented CBT with NTX in the treatment of problem drinking gay and bisexual men, who do not wish to abstain from alcohol, to evaluate their efficacy alone and in combination. We also propose to utilize new data collection technology, Interactive Voice Response, to collect data on daily relations among drinking, sexual behavior and psychological variables thought to mediate treatment response. Our objectives are to evaluation the efficacy of 12 weeks of randomly assigned treatment, with 100 mg of NTX or placebo, combined with brief supportive therapy or modified, behavioral self-control therapy specifically tailored to gay/bisexual men; to evaluate conditional relationships between heavy drinking and likelihood of HIV risk behavior; and to evaluate daily associations among mood, craving, self-efficacy, motivation, and drinking. Assessments will include baseline, 3, 6, & 9 month follow-up. A substudy of the treatment trial will be conducted to collect and bank samples from blood for research aimed at associating naturally occurring differences in DNA with patient response to NTX, and with potential mediational mechanisms of action of NTX. Information gathered on genes or gene products may be used in conjunction with data on clinical psychological factors obtained as part of the clinical trial to evaluate relationships among genetic variants, drug effects, and mechanisms of treatment response. Patients will be asked to give a blood sample at Week 0 of the clinical trial for the purpose of carrying out genetic research.
調査の概要
状態
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10019
- Columbia Addiction Services and Psychotherapy Intervention Research
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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:
- Currently sexually active with other men
- Report drinking at levels substantially in excess of established guidelines for non-hazardous drinking
- Willing to reduce drinking to non-hazardous levels
- English literate (8th grade level)
Exclusion Criteria:
- Current physical disease or condition making participant inappropriate for a medication trial, including total bilirubin elevation >110% AST or ALT elevations >300%
- History of serious psychiatric illness (psychotic disorder, bipolar disorder, or psychiatric illness requiring hospitalization)
- Recent (past three month) initiation of psychotropic medication or psychotherapy, or recent change in psychotropic medication treatment
- Current DSM-IV diagnosis of drug (other than nicotine) dependence, or lifetime diagnosis of opioid dependence
- DSM-IV alcohol dependence diagnosis judged clinically severe, history or present evidence of significant alcohol withdrawal symptoms, or recurrent use of alcohol to alleviate withdrawal
- Regular use of opioids in the past month
- History of of hypersensitivity to NTX
- Considered by study physician not to be suitable for receipt of an investigational drug
- Likely to require treatment with opiate pain medication during the course of the study
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:階乗代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:active medication + psychotherapy
|
適度な認知行動に基づいた心理療法。
治療目標は飲酒量を控えめにすることです。
週に 12 回の 1 時間のセッション。
100 mg oral dosage daily for 12 weeks
|
実験的:placebo + psychotherapy
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プラセボ
適度な認知行動に基づいた心理療法。
治療目標は飲酒量を控えめにすることです。
週に 12 回の 1 時間のセッション。
|
実験的:active medication+brief supportive counseling
|
100 mg oral dosage daily for 12 weeks
Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption.
|
実験的:placebo + brief supportive counseling
|
プラセボ
Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption.
|
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 |
---|---|
アルコールの使用量
時間枠:9ヶ月
|
9ヶ月
|
暴飲暴食の頻度
時間枠:9ヶ月
|
9ヶ月
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
HIV リスク行動の頻度
時間枠:9ヶ月
|
9ヶ月
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (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
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。
プラセボの臨床試験
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Palacky University完了
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
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University Hospital, Strasbourg, France積極的、募集していない