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

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
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. 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
Opiate Addiction Borderline Personality Disorder	Behavioral: Dialectical Behavior therapy Behavioral: Drug Counseling

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
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 National Institute on Drug Abuse (NIDA):

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
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Dialectical Behavior therapy Weekly individual DBT, DBT group skills training, as needed phone calls for coaching, team meeting for psychotherapists, suboxone
2: Active Comparator	Behavioral: Drug Counseling Weekly individual counseling and weekly group therapy following guidelines of drug counseling treatment manual,

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

No publications provided

Responsible Party:	University of Washington ( Marsha Linehan, Ph.D., Principle Investigator )
Study ID Numbers:	NIDA-14997-1, R01-14997-1
Study First Received:	June 30, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00117741 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

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

Additional relevant MeSH terms:

Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

Opioid-Related Disorders
Borderline Personality Disorder
Personality Disorders

ClinicalTrials.gov processed this record on February 08, 2010