This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related health-impairing behaviors. MZP has already successfully been used in the treatment of methamphetamine (detailed further below and in the Appendices).
The investigators hypothesize that those assigned to the MZP plus treatment as usual (TAU) MZP+TAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo (PLO)+TAU arm across the 10-week treatment and follow-up periods.
Enrollment at medication for opioid use disorder (MOUD) treatment at Oregon Recovery & Treatment Center/clinics in Spokane, WA.
Verification of a DSM-5104 diagnosis of an methamphetamine (MA) use disorder (i.e. mild, moderate, or severe),
Aged 18+ years,
Ability to provide written informed consent,
Inability to demonstrate competency to provide informed consent because of cognitive or psychiatric disorders or limited English proficiency,
Prior diagnosis of dementia,
Medically or psychiatrically unsafe to participate as determined by Dr. Layton (Medical Director),
Documented suicide attempt in the past 30 days and/or serious suicide intention or plan as assessed by the Structured Clinical Interview for DSM-5 (SCID-5; clinical trials version)105
Parallel
Mirtazapine
DrugThis is a Phase 2, randomized, double-blind, placebo-controlled clinical trial (RCT) to evaluate the ability of mirtazapine (MZP) to increase methamphetamine (MA) abstinence among treatment-seeking medication for opioid use disorder (MOUD) adults.
Placebo
DrugPlacebo to match.
Urinanalysis Verified Increased Days of MA Abstinence
Determine if participants randomized to the MZP+TAU arm use less MA compared to those assigned to the PLO+TAU arm. We hypothesize that those assigned to the MZP+TAU arm will demonstrate significantly increased rates of biochemically verified MA abstinence relative to those in the PLO+TAU arm across the 10-week treatment period and 3-month follow-up periods.
Actigraphy Verified Improved Sleep Patterns
Determine if participants randomized to the MZP+TAU arm demonstrate improvements in sleep compared to those assigned to the PLO+TAU arm. We hypothesize that those assigned to the MZP+TAU arm will demonstrate improvements in objectively verified sleep relative to the PLO+TAU arm across the 10-week treatment and 3-month follow-up periods.
Self Reported Quantity of Adverse Events
Determine if participants randomized to the MZP+TAU arm experience the same number of adverse events compared to those in the PLO+TAU arm. We hypothesize that those assigned to the MZP+TAU arm will demonstrate statistically equivalent numbers of adverse events relative to those in the PLO+TAU arm across the 10-week treatment and 3-month follow-up periods.
Urinanalysis Verified Increased Days of Abstinence from Other Substances
Determine if participants randomized to the MZP+TAU arm abstain from other substances of abuse (e.g. illicit opioids, cocaine) and demonstrate improvements in MA-associated health-impairing outcomes (e.g. cravings, sleep quality and HIV risk behavior) compared to those assigned to the PLO+TAU arm.
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