Evaluation of DBT Compared to Drug Counseling for Opiate Addicts

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marsha Linehan, University of Washington
ClinicalTrials.gov Identifier:
NCT00117741
First received: June 30, 2005
Last updated: January 31, 2012
Last verified: January 2012

June 30, 2005
January 31, 2012
June 2004
October 2008   (final data collection date for primary outcome measure)
Urinalysis [ Time Frame: one year treatment, one year follow-up ] [ Designated as safety issue: No ]
Drug use
Complete list of historical versions of study NCT00117741 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Suicidal Behavior
  • Depression, anxiety, Axis I diagnostic remission
Not Provided
Not Provided
 
Evaluation of DBT Compared to Drug Counseling for Opiate Addicts
Evaluation of Dialectical Behavior Therapy (DBT)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Opiate Addiction
  • Borderline Personality Disorder
  • 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
  • Behavioral: Drug Counseling
    Weekly individual counseling and weekly group therapy following guidelines of drug counseling treatment manual,
    Other Name: Individual and Group Drug Counseling
  • Experimental: Dialectical Behavior Therapy
    Participants receive standard dialectical behavior therapy and suboxone
    Intervention: Behavioral: Dialectical Behavior Therapy
  • Active Comparator: Drug Counseling
    Participants receive standard individual and group counseling and suboxone.
    Intervention: Behavioral: Drug Counseling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
April 2010
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00117741
R01 DA014997, R01DA014997
Yes
Marsha Linehan, University of Washington
University of Washington
National Institute on Drug Abuse (NIDA)
Principal Investigator: Marsha Linehan, Ph.D. University of Washington
University of Washington
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP