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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
This 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 to match.
Spokane Treatment Center
Spokane, Washington, United States
RECRUITINGUrinanalysis 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.
Time frame: Weeks 2 to Week 22
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.
Time frame: Week 2 to Week 22
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