Opioid/Benzodiazepine Polydrug Abuse
ConditionPolysubstance Abuse
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorWayne State University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Recently admitted and/or not clinically stable in treatment for Substance Use Disorder (SUD) in Wayne County
Using opioids, benzodiazepines (BZD), or BZD/opioid.
Disqualifiers
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)
Trial population
Participants will either be newly admitted to Substance Use Disorder treatment, or in treatment longer but still occasionally using substances.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Multi-domain assessment battery
Other interventionAssessments of emotion regulation, neurocognitive performance, pain, sleep, and substance use. There is no therapeutic intervention; all participants are already independently in treatment for their substance use disorder and we are simply assessing them at baseline visit and 3-month follow-up.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Group 11 intervention
Group B: Group 21 intervention
Group C: Group 31 intervention
Trial outcomes
Primary outcomes
1
Psychopathology
Semi-Structured Clinical Interview for DSM (Face-to-face interview) Evaluates lifetime and current psychiatric and substance use disorders.
Time frame
Administered once during the baseline clinical assessment.2
Beck Depression Inventory-II
Questionnaire measure of current depression symptoms
Time frame
Administered during the baseline clinical assessment, and at the 3-month follow-up visit.3
Snaith-Hamilton Pleasure Scale
Questionnaire 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points.
Time frame
Administered during the baseline clinical assessment, and at the 3-month follow-up visit.4
Perceived Stress Scale
Questionnaire that measures the degree to which situations in one's life are appraised as stressful. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives to be. The scale also includes a number of direct queries about current levels of experienced stress.
Time frame
Administered during the baseline clinical assessment, and at the 3-month follow-up visit.Sponsors and contacts
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Source ClinicalTrials.gov