Back to resultsEvaluation of DBT Compared to Drug Counseling for Opiate Addicts
Primary Purpose
Opiate Addiction, Borderline Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical Behavior Therapy
Drug Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Addiction focused on measuring Opiate Dependence, DBT, Dialectical Behavior Therapy, Drug Counseling, Therapy, Cognitive Behavior
Eligibility 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.
Sites / Locations
- University of Washington, Behavioral Research and Therapy Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dialectical Behavior Therapy
Drug Counseling
Arm Description
Participants receive standard dialectical behavior therapy and suboxone
Participants receive standard individual and group counseling and suboxone.
Outcomes
Primary Outcome Measures
Urinalysis
Secondary Outcome Measures
Suicidal Behavior
Depression, anxiety, Axis I diagnostic remission
Full Information
NCT ID
NCT00117741
First Posted
June 30, 2005
Last Updated
January 31, 2012
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00117741
Brief Title
Evaluation of DBT Compared to Drug Counseling for Opiate Addicts
Official Title
Evaluation of Dialectical Behavior Therapy (DBT)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction, Borderline Personality Disorder
Keywords
Opiate Dependence, DBT, Dialectical Behavior Therapy, Drug Counseling, Therapy, Cognitive Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dialectical Behavior Therapy
Arm Type
Experimental
Arm Description
Participants receive standard dialectical behavior therapy and suboxone
Arm Title
Drug Counseling
Arm Type
Active Comparator
Arm Description
Participants receive standard individual and group counseling and suboxone.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy
Other Intervention Name(s)
DBT
Intervention Description
Weekly individual DBT, DBT group skills training, as needed phone calls for coaching, team meeting for psychotherapists, suboxone
Intervention Type
Behavioral
Intervention Name(s)
Drug Counseling
Other Intervention Name(s)
Individual and Group Drug Counseling
Intervention Description
Weekly individual counseling and weekly group therapy following guidelines of drug counseling treatment manual,
Primary Outcome Measure Information:
Title
Urinalysis
Time Frame
one year treatment, one year follow-up
Secondary Outcome Measure Information:
Title
Suicidal Behavior
Time Frame
one year treatment, one year follow-up
Title
Depression, anxiety, Axis I diagnostic remission
Time Frame
one year treatment, one year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marsha Linehan, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington, Behavioral Research and Therapy Clinics
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1845222
Citation
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.
Results Reference
background
PubMed Identifier
7977884
Citation
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.
Results Reference
background
PubMed Identifier
12062776
Citation
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.
Results Reference
background
PubMed Identifier
10598211
Citation
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.
Results Reference
background
PubMed Identifier
12562741
Citation
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.
Results Reference
background
Links:
URL
http://depts.washington.edu/brtc/
Description
Click here for more information about the Behavioral Research and Therapy Clinics at the University of Washington
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Evaluation of DBT Compared to Drug Counseling for Opiate Addicts
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