Evaluation of DBT - 1 - Full Text View

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. 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.

Condition	Intervention
Dialectical Behavior Therapy Drug Counseling Opioid Dependence	Behavioral: Behavior Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Evaluation of Dialectical Behavior Therapy (DBT)

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Drug use

Secondary Outcome Measures:

Suicidal Behavior
Depression, anxiety, Axis I diagnostic remission

Estimated Enrollment:	86
Study Start Date:	June 2004

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 benzodiazapine 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
	Behavioral Research and Therapy Clinics
	Seattle, Washington, United States, 98195 1525

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Marsha Linehan, Ph.D.	University of Washington

More Information

Study ID Numbers:	NIDA-14997-1, R01-14997-1
First Received:	June 30, 2005
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00117741
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00117741