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.

Condition	Intervention
Dialectical Behavior Therapy Drug Counseling Opioid Dependence	Behavior: Behavior Therapy

Further Study Details: 

Primary Outcomes: Drug use
Secondary Outcomes: Suicidal Behavior; Depression, anxiety, Axis I diagnostic remission
Expected Total Enrollment:  86

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00117741

Kathryn E Korslund, Ph.D.      (206)616-7324    korslund@u.washington.edu

Washington
      Behavioral Research and Therapy Clinics, Seattle,  Washington,  98195 1525,  United States; Recruiting

Study chairs or principal investigators

Marsha Linehan, Ph.D.,  Principal Investigator,  University of Washington   

Study ID Numbers:  NIDA-14997-1; R01-14997-1
Record last reviewed:  June 2005
Last Updated:  July 18, 2005
Record first received:  July 7, 2005
ClinicalTrials.gov Identifier:  NCT00117741
Health Authority: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26