| June 30, 2005 |
| September 19, 2008 |
| June 2004 |
| November 2009 (final data collection date for primary outcome measure) |
| Urinalysis [ Time Frame: one year treatment, one year follow-up ] [ Designated as safety issue: No ] |
| Drug use |
| Complete list of historical versions of study NCT00117741 on ClinicalTrials.gov Archive Site |
- Suicidal Behavior [ Time Frame: one year treatment, one year follow-up ] [ Designated as safety issue: Yes ]
- Depression, anxiety, Axis I diagnostic remission [ Time Frame: one year treatment, one year follow-up ] [ Designated as safety issue: No ]
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- Suicidal Behavior
- Depression, anxiety, Axis I diagnostic remission
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| Evaluation of DBT Compared to Drug Counseling for Opiate Addicts |
| Evaluation of Dialectical Behavior Therapy (DBT) |
The purpose of this study is to compare a one year treatment program of Dialectical Behavior Therapy (DBT) + suboxone for opiate addicted individuals meeting criteria for borderline personality disorder (BPD) to a one year program of standard drug counseling (I/GDC) + suboxone. Drug counseling consists of manualized individual sessions + group therapy. This trial is being completed at two sites, at the University of Washington and at Duke University. One hundred and seventy-two individuals (86 per condition) with opiate dependence and meeting criteria for BPD will be enrolled in a one-year treatment and a one-year follow-up assessment. Each site (University of Washington, Duke) 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 the entire two years. |
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| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
- Opiate Addiction
- Borderline Personality Disorder
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- Behavioral: Dialectical Behavior therapy
- Behavioral: Drug Counseling
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| Active, not recruiting |
| 86 |
| December 2009 |
| November 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 1. Meets SCID-I criteria for opiate dependence. 2. Meets IPDE and SCID criteria for BPD (DSM-IV) 3. Over 18 years old 4. Resides within commuting distance of treatment 5. Consents to outpatient treatment for drug addiction
Exclusion Criteria:
- 1. Bipolar, Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS 2. IQ less than 70; life threatening anorexia; current and chronic absence of shelter; impending jail/prison for more than three weeks (problems which by their presence or severity preclude ability to attend or understand treatment and/or requires priority treatment over SUD treatment) 3. Court order to treatment, court order to treatment or to jail, or agency order to treatment or loss of child custody (due to consequent inability to freely drop-out of treatment) 4. Is pregnant, plans to become pregnant during treatment phase, or becomes pregnant before random assignment to study condition 5. Is unable to tolerate suboxone induction phase 6. Is currently stable on methadone 7. Current benzodiazapine use from which the participant is unwilling to taper 8. Refuses: to discontinue current mental health or drug abuse treatment or random assignment.
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| Both |
| 18 Years to 60 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00117741 |
| Marsha Linehan, Ph.D., Principle Investigator, University of Washington |
| NIDA-14997-1, R01-14997-1 |
| National Institute on Drug Abuse (NIDA) |
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| Principal Investigator: |
Marsha Linehan, Ph.D. |
University of Washington |
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| National Institute on Drug Abuse (NIDA) |
| September 2008 |