Based on this quasi-randomized non-inferiority clinical trial, START NOW is noninferior to TAU—the standard of care—for treating OUD in a buprenorphine/naloxone medications for opioid use disorder office-based opioid treatment setting. START NOW psychotherapy has comparable rates of retention in treatment, days to last group attended, intensity of attendance, and positive drug screen testing. This suggests that adapted START NOW is an effective treatment modality for OUD.
As described previously, treating OUD requires evidence-based psychotherapy to be paired with MOUD. But because there is no gold standard treatment program, low-cost, effective programs that consider the whole patient (medical, psychosocial, socioeconomic factors) need to be developed and implemented (11, 12). Originally applied in the forensic population, START NOW represents a holistic, broad-based skills training program that has clinical effectiveness in the substance use patient population in which co-morbidities are common (23).
Data also suggests that skills-training may be particularly helpful for treating substance use disorders (24, 25). With START NOW, two skills are emphasized; focusing skills and the ABC (Activator, Behavior, Consequence) model for functional analysis of behavior which are key central tenets of this psychotherapy (13). Similarly, other investigations and reviews have found or argued that comprehensive approaches are most effective, and more studies are required (12, 26–28).
We believe that START NOW is a clinically effective psychotherapy program for the OUD patient population. Because START NOW is always free, it may be especially useful in low-resource settings, which have limited access to OUD treatment (29–31). Furthermore, a preliminary pilot study of START NOW for OUD conducted at our institution suggested that patients favorably view the skills-based training aspects START NOW and the diversity of the skills-training provided (14). This is important because patients need confidence in their treatment program which includes not only the clinician but also the psychotherapy provided.
This quasi-randomized clinical trial of START NOW for opioid use disorder patients undergoing buprenorphine/naloxone MOUD in an outpatient program represents a “real world” study design. Again, non-randomization occurred if a participant could only attend treatment at a specific time on a specific day—precluding flexibility for randomization. The rationale of this quasi-randomization method was to perform a study consistent with real-world addiction treatment and in situ limitations (32, 33). Our aim was to create an investigative model for studying a new psychotherapy in an active clinical setting. Often, these settings are filled with inherent challenges that may preclude the ability to perform a true individually randomized controlled trial. Furthermore, demonstrating non-inferiority within a pragmatic study demonstrates its application in clinical practice and provides greater generalizability to the broader clinical setting (34). As such, the aim of this study was to demonstrate non-inferiority, showing that adapted START NOW provides clinical and research utility for the OUD patient population—a group that is inherently challenging to study (35).
As a result of the quasi-randomization method, this trial is limited as an effectiveness trial—rather than an efficacy trial—due to its design and early termination due to the COVID-19 pandemic. Interpretation of drug screen data is limited as a result of the sporadic nature by which these tests were conducted; drug screening occurred at regular intervals for some individuals (weekly), less frequently as determined by group leaders, or on individual’s own willingness to undergo consistent testing. As a result of the missingness and inconsistent data, the sporadic drug screen data is ultimately challenging to study and interpret.
While we aimed to enroll a total of 200 participants, post-hoc power calculations demonstrated that the achieved enrollment of 137 did not compromise power for the retention outcomes analyzed in this paper. However, limitations include early termination of the study and failure to perform long-term follow-up due to the start of the COVID-19 pandemic.
Our study population also was relatively homogenous (Caucasian, middle-age, female). While this may be viewed as a potential limitation, together with START NOW’s application in other patient populations such as the incarcerated population, adolescent girls, etc., we further demonstrate the general applicability of START NOW across different patient populations. We hypothesize that different populations may benefit more with an adapted form of START NOW psychotherapy that uses anecdotes and skills training examples that are specifically more relatable to their sex, ethnicity/race, and even culture. As previously mentioned, START NOW is customizable and adaptable across different populations, which is why it has been applied to correctional facilities, forensic psychiatric hospitals, and even a female adolescent population with oppositional defiant or conduct disorder (18).
Possible future studies include evaluating START NOW psychotherapy for treating OUD in patient populations with different patient demographics, socioeconomic backgrounds, and geopolitical factors. Future areas of research also includes evaluating START NOW’s effects on comorbid mood disorders like depression and anxiety within the OUD population. Additional areas of improvement for future studies includes consistent, mandatory drug screen collection and enhanced adaptations of START NOW specifically to each gender, age group, etc., thereby allowing the material to be even more applicable for each individual and for special populations (26, 36, 37).
Based on our experiences and the data available about trends in OUD, we believe that integrated, comprehensive interventions—centered around skills-training—are needed to effectively treat individuals with OUD. Based on the results of our trial, we propose that adapted START NOW, which is free for public use and therefore is accessible for healthcare professionals in low-resource settings, is an effective psychotherapy for treating OUD. START NOW psychotherapy should be considered an effective tool in settings, such as our own in Southwest Virginia that is disproportionately affected by the opioid crisis, in need of OUD psychotherapy for a patient population with extensive existing comorbidities and psychosocial challenges.