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Adaptive Treatment for Alcohol and Cocaine Dependence

1. August 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

500

Phase

  • Phase 2
  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Presbyterian Medical Center
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19123
        • NorthEast Treatment Center
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • VAMC

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 1-MI-IOP Engaged
Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.
Verhalten: Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Andere Namen:
  • MI
Experimental: 2-MI-IOP Non-Engaged
Randomized to treatment as usual, and do not attend.
Verhalten: Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Andere Namen:
  • MI
Verhalten: Telephone counseling
one telephone counseling session per week for 10 weeks.
Andere Namen:
  • Telephone based stepped care.
Verhalten: Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.
Andere Namen:
  • CBT
Arzneimittel: medication management
Prescription for naltrexone
Andere Namen:
  • MM
Verhalten: Intensive OutPatient Therapy
Return to IOP, group therapy 3 times weekly for about three hours a day.
Andere Namen:
  • IOP
Aktiver Komparator: 3-MI-PC Engaged
Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Verhalten: Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Andere Namen:
  • MI
Verhalten: Telephone counseling
one telephone counseling session per week for 10 weeks.
Andere Namen:
  • Telephone based stepped care.
Verhalten: Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.
Andere Namen:
  • CBT
Experimental: 4-MI-PC Non-engaged
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
Verhalten: Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Andere Namen:
  • MI
Verhalten: Telephone counseling
one telephone counseling session per week for 10 weeks.
Andere Namen:
  • Telephone based stepped care.
Verhalten: Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.
Andere Namen:
  • CBT
Arzneimittel: medication management
Prescription for naltrexone
Andere Namen:
  • MM
Verhalten: Intensive OutPatient Therapy
Return to IOP, group therapy 3 times weekly for about three hours a day.
Andere Namen:
  • IOP

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Treatment Engagement
Zeitfenster: weeks 3 - 12
Number of treatment sessions attended
weeks 3 - 12
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
Zeitfenster: weeks 9 - 12
Number of treatment sessions attended
weeks 9 - 12
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
Zeitfenster: weeks 9 - 12
Number of treatment sessions attended
weeks 9 - 12
Any Drinking Days in Previous Month
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Month 6 (weeks 21 - 24 post baseline)
Percent days of any cocaine use, self reported
Month 6 (weeks 21 - 24 post baseline)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Pennsylvania

Ermittler

  • Hauptermittler: James R. McKay, Ph.D, University of Pennsylvania

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2008

Primärer Abschluss (Tatsächlich)

1. Dezember 2013

Studienabschluss (Tatsächlich)

1. Dezember 2013

Studienanmeldedaten

Zuerst eingereicht

14. Dezember 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Dezember 2009

Zuerst gepostet (Schätzen)

15. Dezember 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. September 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. August 2017

Zuletzt verifiziert

1. August 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 807092
  • IND: 101,486

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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