Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
500 participants
INTERVENTIONAL
2008-10-31
2013-12-31
Brief Summary
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* 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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1-MI-IOP Engaged
Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.
Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
2-MI-IOP Non-Engaged
Randomized to treatment as usual, and do not attend.
Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling
one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.
medication management
Prescription for naltrexone
Intensive OutPatient Therapy
Return to IOP, group therapy 3 times weekly for about three hours a day.
3-MI-PC Engaged
Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling
one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.
4-MI-PC Non-engaged
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling
one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.
medication management
Prescription for naltrexone
Intensive OutPatient Therapy
Return to IOP, group therapy 3 times weekly for about three hours a day.
Interventions
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Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Telephone counseling
one telephone counseling session per week for 10 weeks.
Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.
medication management
Prescription for naltrexone
Intensive OutPatient Therapy
Return to IOP, group therapy 3 times weekly for about three hours a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
18 Years
75 Years
FEMALE
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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James R. McKay, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
VAMC
Philadelphia, Pennsylvania, United States
NorthEast Treatment Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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IND: 101,486
Identifier Type: -
Identifier Source: secondary_id
807092
Identifier Type: -
Identifier Source: org_study_id
NCT02689674
Identifier Type: -
Identifier Source: nct_alias
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