Adaptation and Effectiveness of START NOW in the Treatment of Opioid Addicted Individuals Enrolled in Outpatient Based Opioid Treatment

There is an unmet need for implementing a clinically superior behavioral therapy intervention for medication-assisted treatment of opioid use disorder.

One strategy for fighting the opioid epidemic is to improve treatment and detoxification programs. In the United States, the Drug Addiction Treatment Act of 2000 requires that physicians combine medication-assisted treatment (MAT) with a behavioral intervention. However, there is no clear evidence regarding what form of therapy is most effective when coupled with MAT for opioid use disorder (OUD) management.

This investigation will explore the impact of a novel skills-based psychosocial intervention called START NOW, which has been modified for the substance use disorder (SUD) patient population. The promising therapeutic potential of START NOW is evident in the growing data affirming the program's utility and the psychosocial techniques with substantial supportive evidence incorporated into the program. This investigation will attempt to prove through a number of clinical and behavioral parameters how START NOW with MAT may be an effective treatment program for patients undergoing OUD treatment.

START NOW is an evidence-informed psychotherapy composed of a total of 32-skills-based-sessions, originally designed for inmates in correctional systems. A previous study of incarcerated individuals found that for each additional session of START NOW completed, a 5% reduction in the incident rate of disciplinary reports was noted. In fact, individuals with a higher overall security risk score also had a greater reduction in the number of disciplinary reports with more sessions attended, suggesting that START NOW is an effective behavioral intervention for those who need it most. A follow-up study on these same participants concluded that START NOW appears to have a beneficial clinical effect with each session completed being associated with a 5% decrease in subsequent psychiatric hospital days. Evidence continues to build in support for START NOW as a behavioral intervention as its implementation continues to grow. For example, START NOW is currently being used in correctional facilities in more than 10 states in the US. Using a randomized, controlled trial in Europe, investigators are evaluating START NOW's ability to enhance psychosocial adjustment and well-being and to reduce oppositional and aggressive behavior in 128 institutionalized female adolescents diagnosed with oppositional defiant disorder and/or conduct disorder.

Investigators hypothesize that OUD patients who complete START NOW group therapy will show a statistically greater reduction in impulsivity, delay discounting, and illicit drug use compared to the OUD patients who complete the treatment-as-usual (TAU) because of START NOW's integrated model of care. For example, START NOW combines CBT, the most widely used evidence-based psychosocial intervention for treating mental disorders, with motivational interviewing, which in clinical trials has been shown to be an effective conjunction intervention for SUD. START NOW exercises psychosocial techniques similar to dialectical behavior therapy (DBT), a type of cognitive behavior therapy (CBT) with promising indications for treating SUD because it targets impulsive and self-destructive behaviors. A currently unpublished pilot study using START NOW in an office-based outpatient treatment setting with OUD yielded patient satisfaction data and detailed feedback; this data is being used to guide the modification process of START NOW's materials and delivery so that START NOW is more culturally sensitive and appropriate for the SUD patient population. This proposed investigation will use the revised START NOW participant workbooks and real-life exercises adapted specifically for SUD.