DBT Compared to I/GDC for the Treatment of Opiate Addiction in Emotionally Dysregulated Patients. - 1

Completed · Not applicable

Conditions studied: Dialectical Behavior Therapy, Individual and Group Drug Counseling

In brief

The purpose of this study is to examine the efficacy of DBT compared to a standard drug counseling approach for the treatment of opiate addiction and borderline personality disorder (BPD). Treatment research has repeatedly shown that retention of BPD and substance addicted individuals to be the among the most challenging for therapists. DBT has established itself as one of the most effective treatments for treatment retention of these patients and for reducing parasuicidal and self-injurious behaviors. This study is one of two in a multi-site RCT for the treatment of opiate addiction. DBT has been shown to be efficacious for the treatment of BPD patients and it has been extended in this study to target addictive behaviors in these patients. The study consists of three treatment parts: weekly individual and group therapy and suboxone maintenance medication. Participants are provided therapy on a weekly basis for one year and suboxone for 2 years. Assessments for tracking outcome are conducted every 4 months. It is hypothesized patients in the DBT condition will show a reduction of substance use, parasuicidal and other psychological difficulties and these gains will be maintained through the year of follow-up assessments. In addition, it is predicted that adherence to DBT treatment protocols will be associated with improved outcomes. Finally, it is predicted that treatment "dosage" (average hours of therapy/week) will be positively related to clinical improvement.

Key facts

Study ID

NCT00218595

Run by

Duke University

People needed

39

Starts

2004-08-01

Expected to finish

2009-06-01

Last updated by the study team

2014-08-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 an adequate dose of methadone
• Current benzodiazepine abuse or dependence
• Refuses: to discontinue current mental health or drug abuse treatment or random assignment.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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