Evaluation of DBT Compared to Drug Counseling for Opiate Addicts - Full Text View

Sponsor:	University of Washington
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):	Marsha Linehan, University of Washington
ClinicalTrials.gov Identifier:	NCT00117741

Purpose

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.

Condition	Intervention
Opiate Addiction Borderline Personality Disorder	Behavioral: Dialectical Behavior Therapy Behavioral: Drug Counseling

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation of Dialectical Behavior Therapy (DBT)

Resource links provided by NLM:

MedlinePlus related topics: Personality Disorders

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Urinalysis [ Time Frame: one year treatment, one year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	86
Study Start Date:	June 2004
Study Completion Date:	April 2010
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dialectical Behavior Therapy Participants receive standard dialectical behavior therapy and suboxone	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
Active Comparator: Drug Counseling Participants receive standard individual and group counseling and suboxone.	Behavioral: Drug Counseling Weekly individual counseling and weekly group therapy following guidelines of drug counseling treatment manual, Other Name: Individual and Group Drug Counseling

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117741

Locations

United States, Washington
University of Washington, Behavioral Research and Therapy Clinics
Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Marsha Linehan, Ph.D.

University of Washington

More Information

Additional Information:

Click here for more information about the Behavioral Research and Therapy Clinics at the University of Washington This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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.

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.

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.

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.

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.

Responsible Party:	Marsha Linehan, Professor, University of Washington
ClinicalTrials.gov Identifier:	NCT00117741 History of Changes
Other Study ID Numbers:	R01 DA014997, R01DA014997
Study First Received:	June 30, 2005
Last Updated:	January 31, 2012
Health Authority:	United States: Federal Government

Keywords provided by University of Washington:

Opiate Dependence
DBT
Dialectical Behavior Therapy
Drug Counseling
Therapy, Cognitive Behavior

Additional relevant MeSH terms:

Borderline Personality Disorder
Personality Disorders
Behavior, Addictive
Opioid-Related Disorders

Mental Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders

ClinicalTrials.gov processed this record on February 12, 2012