Therapeutic setting as an essential component of psychedelic research methodology: Reporting recommendations emerging from clinical trials of 3,4-methylenedioxymethamphetamine for post-traumatic stress disorder.

Research of psychedelic assisted therapies is at an all-time high, though few studies highlight extra-pharmacological factors that may affect treatment efficacy. One critical set of attributes includes the therapeutic setting itself, which describe the physical and socio-cultural environments in which the drug-assisted session occurs. Despite enduring consensus of the influence of setting, recommendations for establishing and reporting key setting variables remain sparse across clinical trial protocols and published research methodologies. The purpose of this paper is to: (1) present what is known of the influence and implications of setting to psychedelic-assisted therapies, with a particular focus on 3,4-methylenedioxymethamphetamine (MDMA); and (2) propose a set of reporting guidelines for operationalizing and reporting key setting variables in clinical trials of psychedelic-assisted therapies, based on recommendations emerging from clinical trials of MDMA for PTSD. In fact, recommendations should be expanded to "set" - the subject's mood, expectations, and broader psychological condition - once this is more fully developed in the field. The proposed reporting guidelines offer a means of increasing the volume and variability of data necessary for future empirical examination of key setting attributes influencing treatment efficacy, while preserving practitioner and patient autonomy to co-construct adaptive therapy settings according to their respective needs and expertise.

Association between spine injury and opioid misuse in a prospective cohort of Level I trauma patients.

Objective: To explore patient and treatment factors explaining the association between spine injury and opioid misuse. Design: Prospective cohort study. Setting: Level I trauma center in a Midwestern city. Participants: English speaking patients aged 18 to 75 on Trauma and Orthopedic Surgical Services receiving opioids during hospitalization and prescribed at discharge. Exposure: Spine injury on the Abbreviated Injury Scale. Main outcome measures: Opioid misuse was defined by using opioids: in a larger dose, more often, or longer than prescribed; via a non-prescribed route; from someone other than a prescriber; and/or use of heroin or opium. Exploratory factor groups included demographic, psychiatric, pain, and treatment factors. Multivariable logistic regression estimated the association between spine injury and opioid misuse when adjusting for each factor group. Results: Two hundred eighty-five eligible participants consented of which 258 had baseline injury location data and 224 had follow up opioid misuse data. Most participants were male (67.8%), white (85.3%) and on average 43.1 years old. One-quarter had a spine injury (25.2%). Of those completing follow-up measures, 14 (6.3%) developed misuse. Treatment factors (injury severity, intubation, and hospital length of stay) were significantly associated with spine injury. Spine injury significantly predicted opioid misuse [odds ratio [OR] 3.20, 95% confidence interval [CI] (1.05, 9.78)]. In multivariable models, adjusting for treatment factors attenuated the association between spine injury and opioid misuse, primarily explained by length of stay. Conclusion: Spine injury exhibits a complex association with opioid misuse that predominantly operates through treatment factors. Spine injury patients may represent a subpopulation requiring early intervention to prevent opioid misuse.

Systems consultation for opioid prescribing in primary care: a qualitative study of adaptation.

BACKGROUND: In order to promote guideline-concordant opioid prescribing practices, a blended implementation strategy called systems consultation was pilot tested in four primary care clinics in one US health system. OBJECTIVES: To describe (1) how systems consultation worked during the pilot test and (2) the modifications necessary to adapt this implementation strategy to primary care. METHODS: A team of investigators conducted observations (n=24), focus groups (n=4) and interviews (n=2). The team; kept contact logs documenting all interactions with the intervention clinics and preserved all work products resulting from the intervention. Initial analysis was concurrent with data collection and findings were used to modify the intervention in real time. At the conclusion of the pilot test, a pragmatic descriptive analysis of all data was performed to explore key modifications. RESULTS: Time constraints, entrenched hierarchical structures and a lack of quality improvement skills among clinical staff were the main barriers to implementing systems consultation. Modifications made to address these conditions included creating a consulting team, giving change teams more direction, revising process improvement tools, supporting the use of electronic health record (EHR) functionalities and providing opportunities for shared learning among clinics. DISCUSSION AND CONCLUSION: With the lessons of this research in mind, our goal in future iterations of systems consultation is to give clinics a combination of clinical, organisational change and EHR expertise optimised according to their needs. We believe a streamlined process for assessing the key characteristics identified in this study can be used to develop a plan for this kind of optimisation, or tailoring, and we will be developing such a process as part of an upcoming clinical trial.

Associations between pain coping and opioid use: One-month follow-up results of a prospective study in a cohort of traumatic injury patients.

OBJECTIVE: To examine associations between Pain Catastrophizing Scale (PCS) scores and daily opioid dosage in traumatic injury patients. DESIGN: This was a prospective cohort study with patient assessments at baseline and 1-month following discharge. SETTING: Study visits were conducted at a Regional Level I Trauma Center and by phone at follow-up. PATIENTS: Forty-nine injured inpatients completed baseline PCS. A subsample of 23 patients continued to take prescribed opioid medication at 1-month postdischarge and were included in the current analyses. MAIN OUTCOME MEASURED: Associations between baseline PCS and morphine equivalent daily dose (MEDD) at 1-month follow-up. RESULTS: Controlling for baseline MEDD, baseline PCS score was positively associated with MEDD at 1-month postdischarge (ß= 0.577 [0.399, 1.535]; p = 0.002; R2 of PCS = 0.395). CONCLUSIONS: In the current sample of traumatic injury inpatients, findings indicated that a baseline measure of pain catastrophizing predicts ongoing opioid medication use and dosage at 1-month postdischarge from an inpatient trauma unit.