Opioid/Benzodiazepine Polydrug Abuse
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/27/2019 |
| Start Date: | September 30, 2018 |
| End Date: | September 30, 2020 |
| Contact: | Lisa Sulkowski, BS |
| Email: | lsulkows@med.wayne.edu |
| Phone: | 3139933960 |
Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies
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.
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.
A subset (n=120) of patients newly admitted to Substance Use Disorder treatment in Wayne
County who abuse (Group 1) opioids, (Group 2) benzodiazepines (BZD), and (Group 3) BZD/opioid
(40 patients per group) will be assessed.
Patients will be referred from the treatment regulator and local providers prior to receiving
any psychosocial treatment.
Participants will take part in one 3.5 hour face-to-face assessment prior to entering
treatment during which they will undergo comprehensive assessments of both clinical
(substance use, mental health) and hypothesis-driven measures (affective, neurocognitive,
behavioral).
Participants must provide a supervised alcohol-free breath sample and a urine sample that
will be screened for opioids, methadone, cocaine metabolites, BZDs, barbiturates,
amphetamines.
In a second assessment 3 months later, a subset of these behaviors will be assessed.
Data Collection:
Psychopathology: The Semi-Structured Clinical Interview for DSM-5 will be used to evaluate
lifetime and current psychiatric and substance use disorders, and the Addiction Severity
Index to evaluate the severity of problems in medical, employment, drug, alcohol, legal,
family/social, and psychological domains.
Affective disregulation (inability to regulate emotions), neurocognition, pain and
prescription misuse, insomnia, sleepiness, vigilance, and substance use will be assessed
through the use of computerized measurements as well as paper and pencil questionnaires and
face-to-face interviews.
Sample Size:
In Aim 2 40 patients in each of the 3 drug-use groups (n=120 total) will be evaluated. This
will offer greater statistical power to detect affective and neurocognitive effects than
prior studies, including analysis of sex differences and correction for multiple comparisons.
County who abuse (Group 1) opioids, (Group 2) benzodiazepines (BZD), and (Group 3) BZD/opioid
(40 patients per group) will be assessed.
Patients will be referred from the treatment regulator and local providers prior to receiving
any psychosocial treatment.
Participants will take part in one 3.5 hour face-to-face assessment prior to entering
treatment during which they will undergo comprehensive assessments of both clinical
(substance use, mental health) and hypothesis-driven measures (affective, neurocognitive,
behavioral).
Participants must provide a supervised alcohol-free breath sample and a urine sample that
will be screened for opioids, methadone, cocaine metabolites, BZDs, barbiturates,
amphetamines.
In a second assessment 3 months later, a subset of these behaviors will be assessed.
Data Collection:
Psychopathology: The Semi-Structured Clinical Interview for DSM-5 will be used to evaluate
lifetime and current psychiatric and substance use disorders, and the Addiction Severity
Index to evaluate the severity of problems in medical, employment, drug, alcohol, legal,
family/social, and psychological domains.
Affective disregulation (inability to regulate emotions), neurocognition, pain and
prescription misuse, insomnia, sleepiness, vigilance, and substance use will be assessed
through the use of computerized measurements as well as paper and pencil questionnaires and
face-to-face interviews.
Sample Size:
In Aim 2 40 patients in each of the 3 drug-use groups (n=120 total) will be evaluated. This
will offer greater statistical power to detect affective and neurocognitive effects than
prior studies, including analysis of sex differences and correction for multiple comparisons.
Inclusion Criteria:
- Newly admitted to Substance Use Disorder (SUD) treatment in Wayne County
- Abusing opioids, benzodiazepines (BZD), or BZD/opioid.
Exclusion Criteria:
- Participants with current psychosis, bipolar disorder, or severe depression (i.e.
severe psychiatric disorder).
- Participants with Cocaine Use Disorder.
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