Opioid/Benzodiazepine Polydrug Abuse: Aim 3

Launched by WAYNE STATE UNIVERSITY · Aug 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two types of drugs: opioids (like morphine) and benzodiazepines (like alprazolam), especially when they are used together. The researchers want to understand how these drugs affect mood, thinking, and behavior in people who have a history of using them, either for medical reasons or not. Participants will be given different combinations of these medications or a placebo (a harmless sugar pill) in a controlled setting to see how each affects them.

To join the study, participants should be between the ages of 18 and 65 and have used opioids and/or benzodiazepines in the past 10 years. Importantly, they should not be seeking treatment for substance use issues and must be in good health. Throughout the trial, participants will undergo assessments and may experience different drug effects, helping researchers learn more about the risks and impacts of using these substances together. It’s essential to note that individuals with severe mental health issues, certain health conditions, or those currently using specific medications won't be eligible to participate.

Gender

ALL

Eligibility criteria

• 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