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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DA026454-03 | U.S. NIH Grant/Contract | View source | |
| R01-17372-1 |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to examine the efficacy of DBT compared to a standard drug counseling approach for the treatment of opiate addiction and borderline personality disorder (BPD). Treatment research has repeatedly shown that retention of BPD and substance addicted individuals to be the among the most challenging for therapists. DBT has established itself as one of the most effective treatments for treatment retention of these patients and for reducing parasuicidal and self-injurious behaviors.
This study is one of two in a multi-site RCT for the treatment of opiate addiction. DBT has been shown to be efficacious for the treatment of BPD patients and it has been extended in this study to target addictive behaviors in these patients. The study consists of three treatment parts: weekly individual and group therapy and suboxone maintenance medication. Participants are provided therapy on a weekly basis for one year and suboxone for 2 years. Assessments for tracking outcome are conducted every 4 months.
It is hypothesized patients in the DBT condition will show a reduction of substance use, parasuicidal and other psychological difficulties and these gains will be maintained through the year of follow-up assessments. In addition, it is predicted that adherence to DBT treatment protocols will be associated with improved outcomes. Finally, it is predicted that treatment "dosage" (average hours of therapy/week) will be positively related to clinical improvement.
The study design is a two arm randomized clinical trial comparing a one year treatment program of Dialectical Behavior Therapy (DBT) + suboxone for heroin addicted individuals meeting criteria for borderline personality disorder (BPD) to a one year program of standard drug counseling (I/GDC) + suboxone. Drug counseling will consist of manualized individual sessions + group therapy. Participants in both conditions will be prescribed psychotropic medications following a standardized medication protocol developed specifically for BPD individuals. Each site will enroll 86 clients with both treatment conditions being conducted at each site. Assessments measuring drug use, suicidal behaviors, retention and other treatment-related behaviors, general psychopathology and functioning, and increases in behavioral skills will be given at four month intervals for two years
There are five outcome domains of principal interest in this study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBT | Experimental |
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| I/GDC | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBT | Behavioral | Dialectical behavior therapy plus opiate replacement medication. |
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| Measure | Description | Time Frame |
|---|---|---|
| Psychological assessment interview | Baseline, 4-month, 8-month, 12-month, 16-month, 20-month, 24-month | |
| Urinalysis | 3x/week during active treatment; 1x/week during follow-up year |
| Measure | Description | Time Frame |
|---|---|---|
| Pre- and post-session therapist and client questionnaires | 1x/week during active treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zachary Rosenthal, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| I/GDC |
| Behavioral |
Individual and group drug counseling plus opiate replacement medication. |
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