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Evaluation of DBT Compared to Drug Counseling for Opiate Addicts

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00117741
First Posted: July 8, 2005
Last Update Posted: February 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marsha Linehan, University of Washington
June 30, 2005
July 8, 2005
February 2, 2012
June 2004
October 2008   (Final data collection date for primary outcome measure)
Urinalysis [ Time Frame: one year treatment, one year follow-up ]
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 ]
  • Depression, anxiety, Axis I diagnostic remission [ Time Frame: one year treatment, one year follow-up ]
  • 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
Intervention Model: Parallel Assignment
Masking: Single (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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00117741
R01DA014997( U.S. NIH Grant/Contract )
R01DA014997 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
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