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NCT03696017 · ClinicalTrials.gov registry record
Opioid/Benzodiazepine Polydrug Abuse
A clinical trial of Polysubstance Abuse, sponsored by Wayne State University.
- Recruiting
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT03696017 is a study of Polysubstance Abuse that is actively recruiting participants, run by Wayne State University. The registered enrollment target is 120 participants, below the 173-participant average among 3 other Polysubstance Abuse trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03696017, a study of Polysubstance Abuse, is actively recruiting participants, sponsored by Wayne State University.
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Multi-domain assessment battery
Study Locations (1)
Michigan
- Tolan Park Medical Building - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-02-08 |
| Est. Completion | 2026-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03696017
The ClinicalTrials.gov registry entry for NCT03696017 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 173-participant average among 3 other Polysubstance Abuse trials with a reported enrollment target (31% lower). The listed sponsor is Wayne State University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Polysubstance Abuse appearing as the primary indexed condition, and to 1 intervention - of which Multi-domain assessment battery is the first listed.
NCT03696017 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT03696017 about?
NCT03696017 is a clinical study titled "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 ov...
What is the current status of trial NCT03696017?
This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2019-02-08. Estimated completion is 2026-12.
What conditions does trial NCT03696017 study?
This clinical trial studies the following conditions: Polysubstance Abuse.
What interventions are being tested in trial NCT03696017?
The interventions under investigation include: Multi-domain assessment battery (OTHER).
Who is sponsoring clinical trial NCT03696017?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03696017 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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