Dialectical Behavior TherapyNCT00218595
DBT Compared to I/GDC for the Treatment of Opiate Addiction in Emotionally Dysregulated Patients. - 1
A study testing DBT and I/GDC in people with Dialectical Behavior Therapy and Individual and Group Drug Counseling, run by Duke University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dialectical Behavior Therapy, Individual and Group Drug Counseling
- What is being tested?
- DBT and I/GDC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets SCID-I criteria for opiate dependence.
- Meets IPDE and SCID criteria for BPD (DSM-IV)
- Over 18 years old
- Resides within commuting distance of treatment
- Consents to outpatient treatment for drug addiction
Who cannot join
- Bipolar, Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS
- 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)
- 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)
- Is pregnant, plans to become pregnant during treatment phase, or becomes pregnant before random assignment to study condition
- Is unable to tolerate suboxone induction phase
- Is currently stable on an adequate dose of methadone
- Current benzodiazepine abuse or dependence
- Refuses: to discontinue current mental health or drug abuse treatment or random assignment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Evaluation of Dialectical Behavior Therapy in Treatment of Opioid Addiction and Emotional Problems
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.
Read the 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:
- Drug use: The primary outcome measure here is proportions of urinalysis (UA) coded positive for opiates;
- 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;
- Therapy-interfering behaviors: The primary outcome measure here is maintenance in therapy;
- 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);
- Behavioral skills: The primary outcome measure here is the DBT Skills scale score from the Revised Ways of Coping Checklist (RWCCL);
- 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].
- Being tested
- DBT, I/GDC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBTBehavioural
Dialectical behavior therapy plus opiate replacement medication.
I/GDCBehavioural
Individual and group drug counseling plus opiate replacement medication.
| Study group | Role | What they receive |
|---|---|---|
| DBT | Experimental | Not described Receives: Behavioral: DBT |
| I/GDC | Active comparator | Not described Receives: Behavioral: I/GDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological assessment interview
Measured: Baseline, 4-month, 8-month, 12-month, 16-month, 20-month, 24-month
Urinalysis
Measured: 3x/week during active treatment; 1x/week during follow-up year
Secondary outcomes (1)
Pre- and post-session therapist and client questionnaires
Measured: 1x/week during active treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialectical Behavior TherapyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Zachary Rosenthal, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218595
- Sponsor's protocol ID
- Pro00010957
- Other IDs
- 5R01DA026454-03, R01-17372-1
- Status last verified
- Jan 2013
- First submitted
- 20 Sep 2005
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dialectical Behavior Therapy in Treatment of Opioid Addiction and Emotional Problems
- ClinicalTrials.gov ID
- NCT00218595
- Acronym / sponsor ID
- Pro00010957
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Drug use: The primary outcome measure here is proportions of urinalysis (UA) coded positive for opiates;
- 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;
- Therapy-interfering behaviors: The primary outcome measure here is maintenance in therapy;
- 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);
- Behavioral skills: The primary outcome measure here is the DBT Skills scale score from the Revised Ways of Coping Checklist (RWCCL);
- 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].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBT | Experimental | Behavioral: DBT |
| I/GDC | Active comparator | Behavioral: I/GDC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets SCID-I criteria for opiate dependence.
- Meets IPDE and SCID criteria for BPD (DSM-IV)
- Over 18 years old
- Resides within commuting distance of treatment
- Consents to outpatient treatment for drug addiction
Key exclusion criteria (8 listed)
- Bipolar, Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS
- 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)
- 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)
- Is pregnant, plans to become pregnant during treatment phase, or becomes pregnant before random assignment to study condition
- Is unable to tolerate suboxone induction phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBTDialectical behavior therapy plus opiate replacement medication. | Behavioural | DBT |
| I/GDCIndividual and group drug counseling plus opiate replacement medication. | Behavioural | I/GDC |
Primary outcome
Psychological assessment interview
Time frame: Baseline, 4-month, 8-month, 12-month, 16-month, 20-month, 24-month
Urinalysis
Time frame: 3x/week during active treatment; 1x/week during follow-up year
1 secondary outcome
Pre- and post-session therapist and client questionnaires
Time frame: 1x/week during active treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary Rosenthal, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT and I/GDC in people with Dialectical Behavior Therapy and Individual and Group Drug Counseling, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological assessment interview (time frame: Baseline, 4-month, 8-month, 12-month, 16-month, 20-month, 24-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.