Adaptive Treatment for Alcohol and Cocaine Dependence
tiistai 1. elokuuta 2017 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
500
Vaihe
- Vaihe 2
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Yhdysvallat, 19104
- Presbyterian Medical Center
-
Philadelphia, Pennsylvania, Yhdysvallat, 19123
- NorthEast Treatment Center
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Philadelphia, Pennsylvania, Yhdysvallat, 19104
- VAMC
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 75 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Nainen
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: 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.
Muut nimet:
|
|
Kokeellinen: 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.
Muut nimet:
one telephone counseling session per week for 10 weeks.
Muut nimet:
One CBT session per week, for 10 weeks.
Muut nimet:
Prescription for naltrexone
Muut nimet:
Return to IOP, group therapy 3 times weekly for about three hours a day.
Muut nimet:
|
|
Active Comparator: 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.
Muut nimet:
one telephone counseling session per week for 10 weeks.
Muut nimet:
One CBT session per week, for 10 weeks.
Muut nimet:
|
|
Kokeellinen: 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.
Muut nimet:
one telephone counseling session per week for 10 weeks.
Muut nimet:
One CBT session per week, for 10 weeks.
Muut nimet:
Prescription for naltrexone
Muut nimet:
Return to IOP, group therapy 3 times weekly for about three hours a day.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Treatment Engagement
Aikaikkuna: weeks 3 - 12
|
Number of treatment sessions attended
|
weeks 3 - 12
|
|
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
Aikaikkuna: weeks 9 - 12
|
Number of treatment sessions attended
|
weeks 9 - 12
|
|
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
Aikaikkuna: weeks 9 - 12
|
Number of treatment sessions attended
|
weeks 9 - 12
|
|
Any Drinking Days in Previous Month
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Month 6 (weeks 21 - 24 post baseline)
|
Percent days of any cocaine use, self reported
|
Month 6 (weeks 21 - 24 post baseline)
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: James R. McKay, Ph.D, University of Pennsylvania
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Keskiviikko 1. lokakuuta 2008
Ensisijainen valmistuminen (Todellinen)
Sunnuntai 1. joulukuuta 2013
Opintojen valmistuminen (Todellinen)
Sunnuntai 1. joulukuuta 2013
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 14. joulukuuta 2009
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 14. joulukuuta 2009
Ensimmäinen Lähetetty (Arvio)
Tiistai 15. joulukuuta 2009
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 5. syyskuuta 2017
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 1. elokuuta 2017
Viimeksi vahvistettu
Tiistai 1. elokuuta 2017
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 807092
- IND: 101,486
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .