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Adaptive Treatment for Alcohol and Cocaine Dependence

2017年8月1日 更新者：University of Pennsylvania

  1. Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use over weeks 1-24.

    • Hypothesis 1: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP).
    • Hypothesis 2: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce better cocaine/alcohol use outcomes than an intervention focused on engagement in IOP only (MI-IOP).
    • Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.
    • Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.

  2. Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC varies as a function of engagement group, with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use outcomes over weeks 1-24.

    • Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.
    • Hypothesis 2: The predicted main effect on cocaine/alcohol use outcomes favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

3. Secondary objective #1: Examine outcomes on three secondary measures: percent days abstinent from all substances, negative consequences of drug use, and HIV high risk behaviors.

  • Hypothesis 1: Outcomes on the secondary measures will be better in MI-PC than in MI-IOP.

    4. Secondary objective #2: Test hypotheses concerning potential mediators of the predicted main effect favoring MI-PC over MI-IOP.

  • Hypothesis 1: The predicted advantage of MI-PC over MI-IOP will be mediated by greater increases in motivation, self-efficacy, commitment to abstinence, and self-help involvement in MI-PC.

    5. Secondary objective #3: Test hypotheses concerning effect of additional MI intervention after initial non-engagement persists through 12 weeks.

  • Hypothesis 1: A second telephone MI intervention will produce higher rates of subsequent engagement and less cocaine use than no further MI.

研究の種類

介入

入学 (実際)

500

段階

  • フェーズ2
  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • Presbyterian Medical Center
      • Philadelphia、Pennsylvania、アメリカ、19123
        • NorthEast Treatment Center
      • Philadelphia、Pennsylvania、アメリカ、19104
        • VAMC

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Inclusion Criteria:

  1. meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months;
  2. be > 18 years of age;
  3. be judged clinically appropriate for IOP (e.g., no current psychotic disorder or evidence of severe dementia, and no acute medical problem requiring inpatient treatment;
  4. have no regular IV heroin use during the past year;
  5. have access to a telephone;
  6. be willing to be randomized and participate in research; and
  7. no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will
  8. be required to be metropolitan area residents, and
  9. be able to provide the name, verified telephone number, and address of at least two contacts who can provide locator information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.

Exclusion Criteria:

  1. have a current psychotic disorder (as assessed with the psychotic screen from the MINI) or evidence of dementia severe enough to prevent participation in outpatient treatment;
  2. have acute medical problem requiring immediate inpatient treatment; or
  3. are currently participating in methadone or other forms of DA treatment, other than IOP.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：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
アクティブコンパレータ：1-MI-IOP Engaged
Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.
行動：Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
他の名前：
  • MI
実験的：2-MI-IOP Non-Engaged
Randomized to treatment as usual, and do not attend.
行動：Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
他の名前：
  • MI
行動：Telephone counseling
one telephone counseling session per week for 10 weeks.
他の名前：
  • Telephone based stepped care.
行動：Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.
他の名前：
  • CBT
薬：medication management
Prescription for naltrexone
他の名前：
  • んん
行動：Intensive OutPatient Therapy
Return to IOP, group therapy 3 times weekly for about three hours a day.
他の名前：
  • IOP
アクティブコンパレータ：3-MI-PC Engaged
Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
行動：Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
他の名前：
  • MI
行動：Telephone counseling
one telephone counseling session per week for 10 weeks.
他の名前：
  • Telephone based stepped care.
行動：Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.
他の名前：
  • CBT
実験的：4-MI-PC Non-engaged
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
行動：Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
他の名前：
  • MI
行動：Telephone counseling
one telephone counseling session per week for 10 weeks.
他の名前：
  • Telephone based stepped care.
行動：Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.
他の名前：
  • CBT
薬：medication management
Prescription for naltrexone
他の名前：
  • んん
行動：Intensive OutPatient Therapy
Return to IOP, group therapy 3 times weekly for about three hours a day.
他の名前：
  • IOP

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
Treatment Engagement
時間枠：weeks 3 - 12
Number of treatment sessions attended
weeks 3 - 12
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
時間枠：weeks 9 - 12
Number of treatment sessions attended
weeks 9 - 12
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
時間枠：weeks 9 - 12
Number of treatment sessions attended
weeks 9 - 12
Any Drinking Days in Previous Month
時間枠：Month 2 (weeks 5 - 8 post baseline)
Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Month 2 (weeks 5 - 8 post baseline)
Any Drinking Days in Previous Month
時間枠：Month 3 (weeks 9 - 12 post baseline)
Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Month 3 (weeks 9 - 12 post baseline)
Any Drinking
時間枠：Month 4 (weeks 13 - 15 post baseline)
Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Month 4 (weeks 13 - 15 post baseline)
Any Drinking
時間枠：Month 5 (weeks 16 - 20 post baseline)
Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Month 5 (weeks 16 - 20 post baseline)
Any Drinking
時間枠：Month 6 (weeks 21 - 24 post baseline)
Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Month 6 (weeks 21 - 24 post baseline)
Percent Days Drinking
時間枠：Month 2 (weeks 5 - 8 post baseline)
Percent days of any drinking at follow up, from Time Line Follow Back
Month 2 (weeks 5 - 8 post baseline)
Percent Days Drinking
時間枠：Month 3 (weeks 9 - 12 post baseline)
Percent days of any drinking at follow up, from Time Line Follow Back
Month 3 (weeks 9 - 12 post baseline)
Percent Days Drinking
時間枠：Month 4 (weeks 13 - 16 post baseline)
Percent days of any drinking at follow up, from Time Line Follow Back
Month 4 (weeks 13 - 16 post baseline)
Percent Days Drinking
時間枠：Month 5 (weeks 17 - 20 post baseline)
Percent days of any drinking at follow up, fromTime Line Follow Back
Month 5 (weeks 17 - 20 post baseline)
Percent Days Drinking
時間枠：Month 6 (weeks 21 - 24)
Percent days of any drinking at follow up, from Time Line Follow Back
Month 6 (weeks 21 - 24)
Any Heavy Drinking Days
時間枠：Month 2 (weeks 5 - 8 post baseline)
days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Month 2 (weeks 5 - 8 post baseline)
Any Heavy Drinking Days
時間枠：Month 3 (weeks 9 - 12 post baseline)
five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Month 3 (weeks 9 - 12 post baseline)
Any Heavy Drinking Days
時間枠：Month 4 (weeks 13 - 16 post baseline)
five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Month 4 (weeks 13 - 16 post baseline)
Any Heavy Drinking Days
時間枠：Month 5 (weeks 17 to 20 post baseline)
five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Month 5 (weeks 17 to 20 post baseline)
Any Heavy Drinking Days
時間枠：Month 6 (weeks 21 - 24 post baseline)
five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Month 6 (weeks 21 - 24 post baseline)
Percent Days Heavy Drinking
時間枠：Month 2 (weeks 5 - 8 post baseline)

Percent days heavy drinking at follow up, from Time Line Follow Back

*heavy drinking is defined as five or more drinks per day for men, four or more for women
Month 2 (weeks 5 - 8 post baseline)
Percent Days Heavy Drinking
時間枠：Month 3 (weeks 9 - 12 post baseline)

Percent days heavy drinking at follow up, from Time Line Follow Back

* heavy drinking is defined as five or more drinks per day for men, four or more for women.
Month 3 (weeks 9 - 12 post baseline)
Percent Days Heavy Drinking
時間枠：Month 4 (weeks 13 - 16 post baseline)

Percent days heavy drinking at follow up, from Time Line Follow Back

*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women
Month 4 (weeks 13 - 16 post baseline)
Percent Days Heavy Drinking
時間枠：Month 5 ( weeks 17 - 20 post baseline)

Percent days heavy drinking at follow up, from Time Line Follow Back

* heavy drinking is defined as five or more drinks per drinking day for men, four or more for women
Month 5 ( weeks 17 - 20 post baseline)
Percent Days Heavy Drinking
時間枠：Month 6 (weeks 21 - 24 post baseline)

Percent days heavy drinking at follow up, from Time Line Follow Back

*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women
Month 6 (weeks 21 - 24 post baseline)
Any Cocaine Use
時間枠：Month 3 (weeks 9 - 12 post baseline)
Any cocaine using self report, binary measure of percent days cocaine use.
Month 3 (weeks 9 - 12 post baseline)
Any Cocaine Use
時間枠：Month 4 (weeks 13 - 16 post baseline)
Any cocaine using self report, binary measure of percent days cocaine use
Month 4 (weeks 13 - 16 post baseline)
Any Cocaine Use
時間枠：Month 5 (weeks 17 - 20 post baseline)
Any cocaine using self report, binary measure of percent days cocaine use
Month 5 (weeks 17 - 20 post baseline)
Any Cocaine Use
時間枠：Month 6 (weeks 21 - 24 post baseline)
Any cocaine using self report, binary measure of percent days cocaine use
Month 6 (weeks 21 - 24 post baseline)
Percent Days Cocaine Use
時間枠：Month 3 (weeks 9 - 12 post baseline)
Percent days of any cocaine use, self reported
Month 3 (weeks 9 - 12 post baseline)
Percent Days Cocaine Use
時間枠：Month 5 (weeks 17 - 20 post baseline)
Percent days of any cocaine use, self reported
Month 5 (weeks 17 - 20 post baseline)
Percent Days Cocaine Use
時間枠：Month 6 (weeks 21 - 24 post baseline)
Percent days of any cocaine use, self reported
Month 6 (weeks 21 - 24 post baseline)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Pennsylvania

捜査官

  • 主任研究者：James R. McKay, Ph.D、University of Pennsylvania

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年10月1日

一次修了 (実際)

2013年12月1日

研究の完了 (実際)

2013年12月1日

試験登録日

最初に提出

2009年12月14日

QC基準を満たした最初の提出物

2009年12月14日

最初の投稿 (見積もり)

2009年12月15日

学習記録の更新

投稿された最後の更新 (実際)

2017年9月5日

QC基準を満たした最後の更新が送信されました

2017年8月1日

最終確認日

2017年8月1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

  • 807092
  • IND: 101,486

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。

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