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

NCT00218595 | Completed DMC

• 3 other identifiers: Pro000109575R01DA026454-03R01-17372-1
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dialectical Behavior Therapy; Individual and Group Drug Counseling

Outcome Measures

Primary Outcomes (2)

• Psychological assessment interview

  Baseline, 4-month, 8-month, 12-month, 16-month, 20-month, 24-month

• Urinalysis

  3x/week during active treatment; 1x/week during follow-up year

Secondary Outcomes (1)

• Pre- and post-session therapist and client questionnaires

  1x/week during active treatment

Study Arms (2)

DBT

EXPERIMENTAL

Behavioral: DBT

I/GDC

ACTIVE COMPARATOR

Behavioral: I/GDC

Interventions

DBT BEHAVIORAL

Dialectical behavior therapy plus opiate replacement medication.

DBT

I/GDC BEHAVIORAL

Individual and group drug counseling plus opiate replacement medication.

I/GDC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Study Officials

• Zachary Rosenthal, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 1, 2014

Record last verified: 2013-01

Locations

US (1)