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

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].

Inclusion criteria

• 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

Exclusion criteria

• 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.