Evaluation of DBT Compared to Drug Counseling for Opiate Addicts

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Dialectical Behavior Therapy (DBT)

Conditions
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Opiate Addiction, Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: Dialectical Behavior Therapy
* Behavioral: Drug Counseling


Participation Criteria
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Eligibility Criteria
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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 benzodiazepine use from which the participant is unwilling to taper 8. Refuses: to discontinue current mental health or drug abuse treatment or random assignment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dialectical Behavior Therapy<br>Participants receive standard dialectical behavior therapy and suboxone | Behavioral: Dialectical Behavior Therapy<br>* Weekly individual DBT, DBT group skills training, as needed phone calls for coaching, team meeting for psychotherapists, suboxone<br>* Other names: DBT;|
| Active Comparator: Drug Counseling<br>Participants receive standard individual and group counseling and suboxone. | Behavioral: Drug Counseling<br>* Weekly individual counseling and weekly group therapy following guidelines of drug counseling treatment manual,<br>* Other names: Individual and Group Drug Counseling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinalysis |  | one year treatment, one year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal Behavior |  | one year treatment, one year follow-up | 
| Depression, anxiety, Axis I diagnostic remission |  | one year treatment, one year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opiate Dependence, DBT, Dialectical Behavior Therapy, Drug Counseling, Therapy, Cognitive Behavior