Evaluation of DBT Compared to Drug Counseling for Opiate Addicts

NCT ID: NCT00117741

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Opiate Addiction Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dialectical Behavior Therapy

Participants receive standard dialectical behavior therapy and suboxone

Group Type EXPERIMENTAL

Dialectical Behavior Therapy

Intervention Type BEHAVIORAL

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

Drug Counseling

Participants receive standard individual and group counseling and suboxone.

Group Type ACTIVE_COMPARATOR

Drug Counseling

Intervention Type BEHAVIORAL

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

Interventions

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Dialectical Behavior Therapy

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

Intervention Type BEHAVIORAL

Drug Counseling

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

Intervention Type BEHAVIORAL

Other Intervention Names

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DBT Individual and Group Drug Counseling

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Marsha Linehan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marsha Linehan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington, Behavioral Research and Therapy Clinics

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 1845222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7977884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12062776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10598211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12562741 (View on PubMed)

Related Links

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http://depts.washington.edu/brtc/

Click here for more information about the Behavioral Research and Therapy Clinics at the University of Washington

Other Identifiers

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R01DA014997

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DA014997

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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