| NCT ID | NCT03696017 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wayne State University |
| Condition | Polysubstance Abuse |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2019-02-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2019-02-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Recently admitted and/or not clinically stable in treatment for Substance Use Disorder (SUD) in Wayne County * Using opioids, benzodiazepines (BZD), or BZD/opioid. Exclusion Criteria: * Participants with current psychosis, bipolar disorder, or severe depression (i.e. severe psychiatric disorder) * Individuals with serious neurological disorders, e.g. brain tumor, history of stroke, history of traumatic brain injury w/ loss of consciousness * Cognitive impairment (IQ\<80)
Contact & Investigator
Mark Greenwald, PhD
PRINCIPAL INVESTIGATOR
Wayne State University
Frequently Asked Questions
Who can join the NCT03696017 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Polysubstance Abuse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03696017 currently recruiting?
Yes, NCT03696017 is actively recruiting participants. Contact the research team at gh7962@wayne.edu for enrollment information.
Where is the NCT03696017 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT03696017 clinical trial?
NCT03696017 is sponsored by Wayne State University. The principal investigator is Mark Greenwald, PhD at Wayne State University. The trial plans to enroll 120 participants.