Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies - Study 3

IRB-21-07-3844

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.

2024-03-13

2025-08-01

2025-12-01

Recruiting

Early phase I

24

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Repeated measures, placebo-controlled, randomized crossover', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'drug doses will be encapsulated, and placebo is included in the design', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2024-03-15