Adaptive Treatment for Alcohol and Cocaine Dependence
1. srpna 2017 aktualizováno: University of Pennsylvania
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.
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
500
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Spojené státy, 19104
- Presbyterian Medical Center
-
Philadelphia, Pennsylvania, Spojené státy, 19123
- NorthEast Treatment Center
-
Philadelphia, Pennsylvania, Spojené státy, 19104
- VAMC
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 75 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
Inclusion Criteria:
- meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months;
- be > 18 years of age;
- 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;
- have no regular IV heroin use during the past year;
- have access to a telephone;
- be willing to be randomized and participate in research; and
- no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will
- be required to be metropolitan area residents, and
- 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:
- 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;
- have acute medical problem requiring immediate inpatient treatment; or
- are currently participating in methadone or other forms of DA treatment, other than IOP.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 1-MI-IOP Engaged
Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.
|
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Ostatní jména:
|
|
Experimentální: 2-MI-IOP Non-Engaged
Randomized to treatment as usual, and do not attend.
|
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Ostatní jména:
one telephone counseling session per week for 10 weeks.
Ostatní jména:
One CBT session per week, for 10 weeks.
Ostatní jména:
Prescription for naltrexone
Ostatní jména:
Return to IOP, group therapy 3 times weekly for about three hours a day.
Ostatní jména:
|
|
Aktivní komparátor: 3-MI-PC Engaged
Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
|
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Ostatní jména:
one telephone counseling session per week for 10 weeks.
Ostatní jména:
One CBT session per week, for 10 weeks.
Ostatní jména:
|
|
Experimentální: 4-MI-PC Non-engaged
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
|
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Ostatní jména:
one telephone counseling session per week for 10 weeks.
Ostatní jména:
One CBT session per week, for 10 weeks.
Ostatní jména:
Prescription for naltrexone
Ostatní jména:
Return to IOP, group therapy 3 times weekly for about three hours a day.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Treatment Engagement
Časové okno: weeks 3 - 12
|
Number of treatment sessions attended
|
weeks 3 - 12
|
|
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
Časové okno: weeks 9 - 12
|
Number of treatment sessions attended
|
weeks 9 - 12
|
|
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
Časové okno: weeks 9 - 12
|
Number of treatment sessions attended
|
weeks 9 - 12
|
|
Any Drinking Days in Previous Month
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Month 6 (weeks 21 - 24 post baseline)
|
Percent days of any cocaine use, self reported
|
Month 6 (weeks 21 - 24 post baseline)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: James R. McKay, Ph.D, University of Pennsylvania
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2008
Primární dokončení (Aktuální)
1. prosince 2013
Dokončení studie (Aktuální)
1. prosince 2013
Termíny zápisu do studia
První předloženo
14. prosince 2009
První předloženo, které splnilo kritéria kontroly kvality
14. prosince 2009
První zveřejněno (Odhad)
15. prosince 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
5. září 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. srpna 2017
Naposledy ověřeno
1. srpna 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 807092
- IND: 101,486
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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