Evaluation of DBT Compared to Drug Counseling for Opiate Addicts
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Opiate Addiction Borderline Personality Disorder |
Behavioral: Dialectical Behavior Therapy Behavioral: Drug Counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of Dialectical Behavior Therapy (DBT) |
- Urinalysis [ Time Frame: one year treatment, one year follow-up ] [ Designated as safety issue: No ]
- 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 ]
| Enrollment: | 86 |
| Study Start Date: | June 2004 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dialectical Behavior Therapy
Participants receive standard dialectical behavior therapy and suboxone
|
Behavioral: Dialectical Behavior Therapy
Weekly individual DBT, DBT group skills training, as needed phone calls for coaching, team meeting for psychotherapists, suboxone
Other Name: DBT
|
|
Active Comparator: Drug Counseling
Participants receive standard individual and group counseling and suboxone.
|
Behavioral: Drug Counseling
Weekly individual counseling and weekly group therapy following guidelines of drug counseling treatment manual,
Other Name: Individual and Group Drug Counseling
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Washington | |
| University of Washington, Behavioral Research and Therapy Clinics | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Marsha Linehan, Ph.D. | University of Washington |
More Information
Additional Information:
Publications:
| Responsible Party: | Marsha Linehan, Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00117741 History of Changes |
| Other Study ID Numbers: | R01 DA014997, R01DA014997 |
| Study First Received: | June 30, 2005 |
| Last Updated: | January 31, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Washington:
|
Opiate Dependence DBT Dialectical Behavior Therapy Drug Counseling Therapy, Cognitive Behavior |
Additional relevant MeSH terms:
|
Borderline Personality Disorder Personality Disorders Behavior, Addictive Opioid-Related Disorders |
Mental Disorders Compulsive Behavior Impulsive Behavior Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 23, 2013