DBT Compared to I/GDC for the Treatment of Opiate Addiction in Emotionally Dysregulated Patients. - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00218595
First received: September 20, 2005
Last updated: July 31, 2014
Last verified: January 2013
  Purpose

The purpose of this study is to examine the efficacy of DBT compared to a standard drug counseling approach for the treatment of opiate addiction and borderline personality disorder (BPD). Treatment research has repeatedly shown that retention of BPD and substance addicted individuals to be the among the most challenging for therapists. DBT has established itself as one of the most effective treatments for treatment retention of these patients and for reducing parasuicidal and self-injurious behaviors.

This study is one of two in a multi-site RCT for the treatment of opiate addiction. DBT has been shown to be efficacious for the treatment of BPD patients and it has been extended in this study to target addictive behaviors in these patients. The study consists of three treatment parts: weekly individual and group therapy and suboxone maintenance medication. Participants are provided therapy on a weekly basis for one year and suboxone for 2 years. Assessments for tracking outcome are conducted every 4 months.

It is hypothesized patients in the DBT condition will show a reduction of substance use, parasuicidal and other psychological difficulties and these gains will be maintained through the year of follow-up assessments. In addition, it is predicted that adherence to DBT treatment protocols will be associated with improved outcomes. Finally, it is predicted that treatment "dosage" (average hours of therapy/week) will be positively related to clinical improvement.


Condition Intervention
Dialectical Behavior Therapy
Individual and Group Drug Counseling
Behavioral: DBT
Behavioral: I/GDC

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 in Treatment of Opioid Addiction and Emotional Problems

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Psychological assessment interview [ Time Frame: Baseline, 4-month, 8-month, 12-month, 16-month, 20-month, 24-month ] [ Designated as safety issue: No ]
  • Urinalysis [ Time Frame: 3x/week during active treatment; 1x/week during follow-up year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pre- and post-session therapist and client questionnaires [ Time Frame: 1x/week during active treatment ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: August 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DBT Behavioral: DBT
Dialectical behavior therapy plus opiate replacement medication.
Active Comparator: I/GDC Behavioral: I/GDC
Individual and group drug counseling plus opiate replacement medication.

Detailed Description:

The study design is a two arm randomized clinical trial comparing a one year treatment program of Dialectical Behavior Therapy (DBT) + suboxone for heroin addicted individuals meeting criteria for borderline personality disorder (BPD) to a one year program of standard drug counseling (I/GDC) + suboxone. Drug counseling will consist of manualized individual sessions + group therapy. Participants in both conditions will be prescribed psychotropic medications following a standardized medication protocol developed specifically for BPD individuals. Each site 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 two years

There are five outcome domains of principal interest in this study:

  1. Drug use: The primary outcome measure here is proportions of urinalysis (UA) coded positive for opiates;
  2. Suicidal behaviors: The primary outcome measure here is number of suicides + suicide attempts. The domain of suicidal behaviors also includes (a) the number, medical risk, risk/rescue score and suicide intent of all parasuicide, (b) the number of suicide threats and suicide crises, and (c) the level of suicidal ideation and suicide intent;
  3. Therapy-interfering behaviors: The primary outcome measure here is maintenance in therapy;
  4. Quality of life interfering behaviors: The primary outcome measure here is combined number of days on a psychiatric inpatient unit + days in jail (THI, SHI);
  5. Behavioral skills: The primary outcome measure here is the DBT Skills scale score from the Revised Ways of Coping Checklist (RWCCL);
  6. Risky sexual behavior: the primary outcome measure here is the number of risky sexual behaviors in the time period [Casual Partners questionnaire revised [CPQ-R] and diary card].
  Eligibility

Ages Eligible for Study:   18 Years to 70 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 an adequate dose of methadone
  7. Current benzodiazepine abuse or dependence
  8. Refuses: to discontinue current mental health or drug abuse treatment or random assignment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218595

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Zachary Rosenthal, Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00218595     History of Changes
Other Study ID Numbers: Pro00010957, 5R01DA026454-03, R01-17372-1
Study First Received: September 20, 2005
Last Updated: July 31, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 26, 2014