NCT00117741

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

4.3 years

First QC Date

June 30, 2005

Last Update Submit

January 31, 2012

Conditions

Keywords

Opiate DependenceDBTDialectical Behavior TherapyDrug CounselingTherapy, Cognitive Behavior

Outcome Measures

Primary Outcomes (1)

  • Urinalysis

    one year treatment, one year follow-up

Secondary Outcomes (2)

  • Suicidal Behavior

    one year treatment, one year follow-up

  • Depression, anxiety, Axis I diagnostic remission

    one year treatment, one year follow-up

Study Arms (2)

Dialectical Behavior Therapy

EXPERIMENTAL

Participants receive standard dialectical behavior therapy and suboxone

Behavioral: Dialectical Behavior Therapy

Drug Counseling

ACTIVE COMPARATOR

Participants receive standard individual and group counseling and suboxone.

Behavioral: Drug Counseling

Interventions

Weekly individual DBT, DBT group skills training, as needed phone calls for coaching, team meeting for psychotherapists, suboxone

Also known as: DBT
Dialectical Behavior Therapy
Drug CounselingBEHAVIORAL

Weekly individual counseling and weekly group therapy following guidelines of drug counseling treatment manual,

Also known as: Individual and Group Drug Counseling
Drug Counseling

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. 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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington, Behavioral Research and Therapy Clinics

Seattle, Washington, 98195, United States

Location

Related Publications (5)

  • Linehan MM, Armstrong HE, Suarez A, Allmon D, Heard HL. Cognitive-behavioral treatment of chronically parasuicidal borderline patients. Arch Gen Psychiatry. 1991 Dec;48(12):1060-4. doi: 10.1001/archpsyc.1991.01810360024003.

    PMID: 1845222BACKGROUND
  • Linehan MM, Tutek DA, Heard HL, Armstrong HE. Interpersonal outcome of cognitive behavioral treatment for chronically suicidal borderline patients. Am J Psychiatry. 1994 Dec;151(12):1771-6. doi: 10.1176/ajp.151.12.1771.

    PMID: 7977884BACKGROUND
  • Linehan MM, Dimeff LA, Reynolds SK, Comtois KA, Welch SS, Heagerty P, Kivlahan DR. Dialectical behavior therapy versus comprehensive validation therapy plus 12-step for the treatment of opioid dependent women meeting criteria for borderline personality disorder. Drug Alcohol Depend. 2002 Jun 1;67(1):13-26. doi: 10.1016/s0376-8716(02)00011-x.

    PMID: 12062776BACKGROUND
  • Linehan MM, Schmidt H 3rd, Dimeff LA, Craft JC, Kanter J, Comtois KA. Dialectical behavior therapy for patients with borderline personality disorder and drug-dependence. Am J Addict. 1999 Fall;8(4):279-92. doi: 10.1080/105504999305686.

    PMID: 10598211BACKGROUND
  • Verheul R, Van Den Bosch LM, Koeter MW, De Ridder MA, Stijnen T, Van Den Brink W. Dialectical behaviour therapy for women with borderline personality disorder: 12-month, randomised clinical trial in The Netherlands. Br J Psychiatry. 2003 Feb;182:135-40. doi: 10.1192/bjp.182.2.135.

    PMID: 12562741BACKGROUND

Related Links

MeSH Terms

Conditions

Opioid-Related DisordersBorderline Personality Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPersonality Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marsha Linehan, Ph.D.

    University of Washington

    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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 8, 2005

Study Start

June 1, 2004

Primary Completion

October 1, 2008

Study Completion

April 1, 2010

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations