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Adaptive Treatment for Alcohol and Cocaine Dependence

1. august 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

500

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Presbyterian Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19123
        • NorthEast Treatment Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • VAMC

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2008

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

14. december 2009

Først indsendt, der opfyldte QC-kriterier

14. december 2009

Først opslået (Skøn)

15. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 807092
  • IND: 101,486

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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