Health TrialsbyHealthPanel

Opioid/Benzodiazepine Polydrug Abuse: Aim 3

ConditionsOpioid AbuseBenzodiazepine AbusePolysubstance Abuse
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWayne State University

About this trial

In this study, the investigators will measure affective, neurocognitive and behavioral outcomes related to chronic use of opioids and benzodiazepines (screening phase), and in response to the administration of the opioid morphine, the benzodiazepine alprazolam, morphine then alprazolam, alprazolam then morphine, morphine+alprazolam simultaneously, and placebo (laboratory pharmacology experiment). The latter will enable the investigators to assess the effects of an opioid alone, benzodiazepine alone, concurrent and simultaneous administration of opioid+benzodiazepine, relative to a placebo control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

must self-report past 10-year experience taking opioid and sedative drugs (for therapeutic or non-therapeutic reasons), but not necessarily at the same time. As an alternative to the sedative drug exposure requirement, participants must have used alcohol on at least 3 separate days during the past month. Participants may have current mild- or moderate-severity Opioid Use Disorder or current mild- or moderate-severity Sedative Use Disorder;

must not be seeking treatment for their substance use problems;

must be in current good overall health

Disqualifiers

meet DSM-5 criteria for current psychosis, bipolar disorder, or severe depression (i.e. severe psychiatric disorder);

meet DSM-5 criteria for severe substance use disorder for any substance (e.g. Sedative, Opioid, Alcohol);

past-month benzodiazepine or opioid prescription (which would suggest daily use, tolerance, or withdrawal upon cessation);

report of past-year any-drug overdose or suicide attempt/ideation;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Morphine

    Drug

    immediate release oral 15mg dose

  • Alprazolam

    Drug

    oral 0.25mg dose

  • Placebo

    Drug

    Lactose

Treatment groups

24 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Placebo drugPlacebo comparator 1 intervention
Group B: Morphine aloneActive comparator 1 intervention
Group C: Alprazolam aloneActive comparator 1 intervention
Group D: Morphine then alprazolamActive comparator 2 interventions
Group E: Alprazolam then morphineActive comparator 2 interventions
Group F: Morphine+alprazolam simultaneouslyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

State anxiety

State Trait Anxiety Inventory - state anxiety scale total score

Time frame
within-session peak change from pre-drug baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
2

Positive affect

Positive and Negative Affect Scale-Short Form (PANAS-SF) positive affect scale score

Time frame
within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
3

Negative affect

Positive and Negative Affect Scale-Short Form (PANAS-SF) negative affect scale score

Time frame
within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks

Secondary outcomes

1

Symbol matching performance task

Digit Symbol Substitution Task (DSST) symbol matching total score

Time frame
difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
2

Impulsivity performance task accuracy

Go/No task percentage of trials correct

Time frame
difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
3

Cognitive flexibility performance task

Wisconsin Card Sorting Task (WCST) percentage of trials correct

Time frame
difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
4

Cognitive inhibition performance task

Addiction Stroop Task, reaction time to drug vs. neutral words presented in different colors

Time frame
difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wayne State University

Lead sponsor

Henry Ford Health System

Collaborator

Source ClinicalTrials.gov
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