Opioid/Benzodiazepine Polydrug Abuse: Aim 3

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Wayne State University
Study ID
NCT05006079
Phase
PHASE2
Status
Recruiting
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Conditions

  • Benzodiazepine Abuse
  • Opioid Abuse
  • Polysubstance Abuse

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Morphine — DRUG
    immediate release oral 15mg dose
  • Alprazolam — DRUG
    oral 0.25mg dose
  • Placebo — DRUG
    Lactose

Study Details

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.

Key Dates

Start date
Mar 13, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo drug
    Lactose, administered both at 9:30 am and 12:00 pm
  • Active Comparator: Morphine alone
    15mg immediate-release oral morphine, administered both at 9:30 am and 12:00 pm
  • Active Comparator: Alprazolam alone
    0.25mg oral alprazolam, administered at both 9:30 am and 12:00 pm
  • Active Comparator: Morphine then alprazolam
    15mg oral morphine administered at 9:30 am, then 0.25mg oral alprazolam administered at 12:00 pm
  • Active Comparator: Alprazolam then morphine
    0.25mg oral alprazolam administered at 9:30 am, then 15mg oral morphine administered at 12:00 pm
  • Active Comparator: Morphine+alprazolam simultaneously
    morphine 15mg + 0.25mg alprazolam at 9:30 am, then morphine 15mg + 0.25mg alprazolam at 12:00 pm

Primary Outcome Measure

State anxiety [ 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tolan Park Medical BuildingDetroitMichigan48201
Mark Greenwald, PhD
[email protected]
313-993-3965

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By research site
Tolan Park Medical Building· Detroit, MI

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