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Clinical Trials/NCT00117741
NCT00117741
Completed
Not Applicable

Evaluation of Dialectical Behavior Therapy (DBT)

University of Washington1 site in 1 country86 target enrollmentJune 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opiate Addiction
Sponsor
University of Washington
Enrollment
86
Locations
1
Primary Endpoint
Urinalysis
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
April 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marsha Linehan

Professor

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Meets SCID-I criteria for opiate dependence.
  • Meets IPDE and SCID criteria for BPD (DSM-IV)
  • Over 18 years old
  • Resides within commuting distance of treatment
  • Consents to outpatient treatment for drug addiction

Exclusion Criteria

  • Bipolar, Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS
  • 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)
  • 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)
  • Is pregnant, plans to become pregnant during treatment phase, or becomes pregnant before random assignment to study condition
  • Is unable to tolerate suboxone induction phase
  • Is currently stable on methadone
  • Current benzodiazepine use from which the participant is unwilling to taper
  • Refuses: to discontinue current mental health or drug abuse treatment or random assignment.

Outcomes

Primary Outcomes

Urinalysis

Time Frame: one year treatment, one year follow-up

Secondary Outcomes

  • Suicidal Behavior(one year treatment, one year follow-up)
  • Depression, anxiety, Axis I diagnostic remission(one year treatment, one year follow-up)

Study Sites (1)

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