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Adaptive Treatment for Alcohol and Cocaine Dependence

1 agosto 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

500

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Presbyterian Medical Center
      • Philadelphia, Pennsylvania, Stati Uniti, 19123
        • NorthEast Treatment Center
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • VAMC

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

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

Cosa sta misurando lo studio?

Misure di risultato primarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pennsylvania

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2008

Completamento primario (Effettivo)

1 dicembre 2013

Completamento dello studio (Effettivo)

1 dicembre 2013

Date di iscrizione allo studio

Primo inviato

14 dicembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

14 dicembre 2009

Primo Inserito (Stima)

15 dicembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 settembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 agosto 2017

Ultimo verificato

1 agosto 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 807092
  • IND: 101,486

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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