RECRUITING

Opioid/benzodiazepine Polydrug Abuse

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Opioid/benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies

Quick Facts

Study Start:2019-02-08
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03696017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Recently admitted and/or not clinically stable in treatment for Substance Use Disorder (SUD) in Wayne County
  2. * Using opioids, benzodiazepines (BZD), or BZD/opioid.
  1. * Participants with current psychosis, bipolar disorder, or severe depression (i.e. severe psychiatric disorder)
  2. * Individuals with serious neurological disorders, e.g. brain tumor, history of stroke, history of traumatic brain injury w/ loss of consciousness
  3. * Cognitive impairment (IQ\<80)

Contacts and Locations

Study Contact

Heidi Aguas
CONTACT
3139933960
gh7962@wayne.edu

Principal Investigator

Mark Greenwald, PhD
PRINCIPAL_INVESTIGATOR
Wayne State University

Study Locations (Sites)

Tolan Park Medical Building
Detroit, Michigan, 48201
United States

Collaborators and Investigators

Sponsor: Wayne State University

  • Mark Greenwald, PhD, PRINCIPAL_INVESTIGATOR, Wayne State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-08
Study Completion Date2025-12

Study Record Updates

Study Start Date2019-02-08
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Opioid Abuse
  • Benzodiazepine abuse

Additional Relevant MeSH Terms

  • Polysubstance Abuse