Ignite Creation Date:
2024-05-05 @ 10:07 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01032135
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2009-12-14
Brief Title:
Adaptive Treatment for Alcohol and Cocaine Dependence
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Adaptive Treatment for Alcohol and Cocaine Dependence
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 cocainealcohol use over weeks 1-24
Hypothesis 1 An intervention that explores several possible treatment options with the patient and provides the chosen option eg MI-PC will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only eg MI-IOP
Hypothesis 2 An intervention that explores several possible treatment options with the patient and provides the chosen option eg MI-PC will produce better cocainealcohol 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 cocainealcohol 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 cocainealcohol 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 cocainealcohol 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 cocainealcohol 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
Hypothesis 1 An intervention that explores several possible treatment options with the patient and provides the chosen option eg MI-PC will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only eg MI-IOP
Hypothesis 2 An intervention that explores several possible treatment options with the patient and provides the chosen option eg MI-PC will produce better cocainealcohol 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 cocainealcohol 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 cocainealcohol 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 cocainealcohol 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 cocainealcohol 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 101486 | None | None | None |