Evaluation of DBT Compared to Drug Counseling for Opiate Addicts

Not Applicable

Completed

• Conditions: Opiate Addiction; Borderline Personality Disorder
• Interventions: Behavioral: Drug Counseling; Behavioral: Dialectical Behavior Therapy

• Registration Number: NCT00117741
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-08
• Primary Completion: 2008-10
• Study Completion: 2010-04
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

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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 benzodiazepine 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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Counseling	Drug Counseling	Participants receive standard individual and group counseling and suboxone.
Dialectical Behavior Therapy	Dialectical Behavior Therapy	Participants receive standard dialectical behavior therapy and suboxone

Primary Outcome Measures

Name	Time	Method
Urinalysis	one year treatment, one year follow-up

Secondary Outcome Measures

Name	Time	Method
Suicidal Behavior	one year treatment, one year follow-up
Depression, anxiety, Axis I diagnostic remission	one year treatment, one year follow-up

Trial Locations

Locations (1)

University of Washington, Behavioral Research and Therapy Clinics; 🇺🇸 Seattle, Washington, United States