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CompletedNCT00117741Updated Feb 2, 2012

Evaluation of DBT Compared to Drug Counseling for Opiate Addicts

An interventional study of Dialectical Behavior Therapy and Drug Counseling in Opiate Addiction and Borderline Personality Disorder, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-02-02.

Sponsored by University of Washington · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Opiate Addiction
  • Borderline Personality Disorder

Keywords

  • Opiate Dependence
  • DBT
  • Dialectical Behavior Therapy
  • Drug Counseling
  • Therapy, Cognitive Behavior
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In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 86 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Dialectical Behavior Therapy

    Participants receive standard dialectical behavior therapy and suboxone

    Behavioral: Dialectical Behavior Therapy

  • Active comparator
    Drug Counseling

    Participants receive standard individual and group counseling and suboxone.

    Behavioral: Drug Counseling

Interventions

  • BehavioralDialectical Behavior Therapy

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

    Also known as: DBT

  • BehavioralDrug Counseling

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

    Also known as: Individual and Group Drug Counseling

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What researchers measure

Primary outcomes

  1. Urinalysis

    Time frame: one year treatment, one year follow-up

Secondary outcomes

  1. Suicidal Behavior

    Time frame: one year treatment, one year follow-up

  2. Depression, anxiety, Axis I diagnostic remission

    Time frame: one year treatment, one year follow-up

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Study locations

1 site
  • University of Washington, Behavioral Research and Therapy Clinics
    Seattle, Washington 98195, United States
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References and documents

Publications

  • 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. PubMed 1845222 ↗
  • 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. PubMed 7977884 ↗
  • 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. PubMed 12062776 ↗
  • 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. PubMed 10598211 ↗
  • 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. PubMed 12562741 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00117741
Lead sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Marsha Linehan (Professor, University of Washington) — Principal investigator
First posted
Jul 8, 2005
Start date
Jun 2004
Primary completion
Oct 2008
Completion
Apr 2010
Last update
Feb 2, 2012

Study contacts

Marsha Linehan, Ph.D.
principal investigator · University of Washington

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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