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Adaptive Treatment for Alcohol and Cocaine Dependence

1 augusti 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

500

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Presbyterian Medical Center
      • Philadelphia, Pennsylvania, Förenta staterna, 19123
        • NorthEast Treatment Center
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • VAMC

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Pennsylvania

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2008

Primärt slutförande (Faktisk)

1 december 2013

Avslutad studie (Faktisk)

1 december 2013

Studieregistreringsdatum

Först inskickad

14 december 2009

Först inskickad som uppfyllde QC-kriterierna

14 december 2009

Första postat (Uppskatta)

15 december 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 september 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 augusti 2017

Senast verifierad

1 augusti 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 807092
  • IND: 101,486

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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