Recruiting
Phase 2

Observational Study

Sponsor:

Wayne State University

Code:

NCT05006079

Conditions

Opioid Abuse

Benzodiazepine Abuse

Polysubstance Abuse

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Morphine

Alprazolam

Placebo

Study Details

Brief summary:

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.

Conditions

Opioid Abuse

Benzodiazepine Abuse

Polysubstance Abuse

Study ID

NCT05006079

Start date

Mar 13, 2024

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • exhibit cognitive impairment (IQ < 80 on the Shipley Institute of Living Scale);
  • neurological, cardiovascular, pulmonary, or systemic diseases (see specific exclusionary conditions under Protection of Human Subjects);
  • body mass index > 38 kg/m2;
  • females who are pregnant (urine), lactating or heterosexually active (self-report) and not using medically approved birth control;
  • treatment with methadone, buprenorphine or naltrexone;
  • past 30-day use of contraindicated medications;
  • alcohol-positive breath sample (>.02% breath alcohol concentration);
  • urine sample positive for methadone, cocaine, amphetamines, or barbiturates (<300 ng/ml)
  • intolerance of lactose

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

Morphine

immediate release oral 15mg dose

Alprazolam

oral 0.25mg dose

Placebo

Lactose

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 ]
  • Positive affect [ 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 ]
  • Negative affect [ 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 ]

Central Contacts and Locations

Central contacts

Mark K Greenwald, PhD

313-993-3965mgreen@med.wayne.edu

Heidi Aguas

313-993-3960gh7962@wayne.edu

Locations

Tolan Park Medical Building

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Mark Greenwald, PhD

313-993-3965mgreen@med.wayne.edu

More Information

Sponsor

Wayne State University

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2025-12-30.