Investigating the effects of opioids and benzodiazepines on substance abuse

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

This study is trying to see how using opioids and benzodiazepines together affects emotions and decision-making in people who have struggled with substance abuse.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Wayne State University (other)
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT05006079 on ClinicalTrials.gov

What this trial studies

This study aims to explore the neurocognitive and behavioral outcomes associated with chronic use of opioids and benzodiazepines. Participants will undergo a screening phase to assess affective dysregulation and will then participate in a laboratory experiment where they will receive various combinations of morphine, alprazolam, and placebo. The goal is to understand how these substances affect emotional regulation and decision-making processes in individuals with a history of polysubstance abuse. The findings could provide insights into the mechanisms that perpetuate addiction and inform future treatment strategies.

Who should consider this trial

Good fit: Ideal candidates are individuals with a history of opioid and benzodiazepine use who are not currently seeking treatment for their substance use problems.

Not a fit: Patients with severe psychiatric disorders or those currently experiencing severe substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment options for individuals struggling with opioid and benzodiazepine abuse.

How similar studies have performed: While there have been studies on opioid and benzodiazepine use separately, this specific dual-deficit approach is relatively novel and has not been extensively tested.

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

Where this trial is running

Detroit, Michigan

• Tolan Park Medical Building — Detroit, Michigan, United States (RECRUITING)

Study contacts

• Principal investigator: Mark K Greenwald, PhD — Wayne State University
• Study coordinator: Mark K Greenwald, PhD

Conditions: Opioid Abuse, Benzodiazepine Abuse, Polysubstance Abuse