Clinical Research Directory

Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.

CEDRN: Opioid Registry

Unregulated opioids remain a leading driver of preventable mortality and potential years of life lost in Canada. Emergency departments (EDs)-open 24/7 and frequently accessed by people who use drugs-offer critical opportunities to reverse toxicity, mitigate harm, and initiate treatment. Yet, high quality evidence to guide ED care for patients with opioid poisoning and concomitant opioid dependence or opioid use disorder is limited. The investigators aim to establish a pan Canadian registry of patients presenting to EDs with opioid poisoning to generate timely, practice informing evidence. The investigators will create the Canadian Emergency Department Research Network (CEDRN) Opioid Registry across participating EDs nationwide. Using automated screening of electronic health records (EHRs), the investigators will identify consecutive patients of all ages with suspected or confirmed opioid poisoning at their index ED visit. The project's objectives are to establish a pan-Canadian registry of Emergency Department patients presenting with opioid poisoning, harmonize data collection across participating sites, describe variations in patient characteristics, clinical practice and outcomes, and derive a clinical decision rule to predict the risk of dying within 60 days. The expected outcomes include advancing healthcare delivery, improving patient and provider experiences, and enhancing population health and health system sustainability for individuals with opioid poisoning. This research is crucial for addressing the opioid crisis in Canada and has the potential to significantly impact patient care and outcomes.

Opioid/Benzodiazepine Polydrug Abuse

Benzodiazepine (BZD)/opioid polysubstance abuse (PSA) dramatically increases risks of overdose, disability and death; however, little is known about phenotypes that could be targeted to decrease this use and these associated risks. The opioid abuse epidemic is generating unprecedented numbers of overdoses (OD) and deaths from prescribed and illegal sources (e.g. fentanyl combined with, or sold as, heroin). Yet, medical and epidemiological data suggest these adverse outcomes are not solely due to over-consumption of opioids.The FDA recognizes the health danger of BZD/opioid PSA, and issued labeling changes for prescribing BZDs and opioids. Impact of these changes is unclear and could be minimal if people obtain these substances illegally. BZD abuse can be harmful alone or combined with opioids, as BZDs: (a) contribute to OD/death e.g. 31% of opioid OD-related deaths from 1999 to 2011 were related to coincident BZD use, BZD co-use is dose-dependently related to mortality and rates of BZD OD deaths have sharply increased. (b) exacerbate progression and adverse outcomes of opioid abuse. and (c) worsen behavioral impairment from opioids, increase rates of falls and fractures, motor vehicle accidents, and sleep-disordered breathing. There has been limited systematic research of BZD/opioid PSA. This is a major gap because BZD are often co-prescribed with opioids (in 33 to 50% of cases) and are easily obtained illegally. In response to these problems, there is an urgent need to obtain population-level, clinical pharmacology, and mechanistic data to test our unified hypothesis of dual-deficit in affective/hedonic regulation.

Opioid/Benzodiazepine Polydrug Abuse: Aim 3

In this study, the investigators will measure affective, neurocognitive and behavioral outcomes related to chronic use of opioids and benzodiazepines (screening phase), and in response to the administration of the opioid morphine, the benzodiazepine alprazolam, morphine then alprazolam, alprazolam then morphine, morphine+alprazolam simultaneously, and placebo (laboratory pharmacology experiment). The latter will enable the investigators to assess the effects of an opioid alone, benzodiazepine alone, concurrent and simultaneous administration of opioid+benzodiazepine, relative to a placebo control.

Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

The purpose of this study is to 1) examine barriers and facilitators to implementation of MI and MORE for polysubstance use and evaluate strategies for optimizing training, fidelity, and clinic uptake, and 2) evaluate patient outcomes related to the effectiveness of MORE decreasing opioid, tobacco, and other drug use.