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Mirtazapine for Methamphetamine and Opioid Use Disorders (MIRROM Trial)
Phase 2
Recruiting
Led By Sterling M McPherson, PhD
Research Sponsored by Washington State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18+ years
No current acute illness requiring prolonged medical care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2 to week 24
Summary
"This trial will test whether Mirtazapine (MZP), a medication known for treating certain conditions, can help reduce methamphetamine use and related harmful behaviors in patients receiving treatment for opioid use disorder
Who is the study for?
This trial is for adults over 18 with methamphetamine use disorder who are already enrolled in opioid treatment programs. They must have stable vital signs, a confirmed diagnosis of methamphetamine use disorder, and at least one positive drug test for methamphetamines. Participants need to show they can stick to the treatment plan and be generally healthy without serious illnesses.
What is being tested?
The study tests if Mirtazapine helps reduce methamphetamine use among patients receiving opioid addiction treatments compared to a placebo. It's designed to see if those taking Mirtazapine plus usual care show better abstinence from drugs and improved health behaviors over a 10-week period than those on placebo.
What are the potential side effects?
Mirtazapine may cause drowsiness, increased appetite, weight gain, dry mouth, or constipation. Some people might also experience changes in mood or abnormal thoughts and sensations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am not currently suffering from a serious illness that needs long-term treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2 to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2 to week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Urinanalysis Verified Increased Days of MA Abstinence
Secondary study objectives
Actigraphy Verified Improved Sleep Patterns
Other study objectives
Self Reported Quantity of Adverse Events
Urinanalysis Verified Increased Days of Abstinence from Other Substances
Side effects data
From 2014 Phase 4 trial • 38 Patients • NCT0117867144%
nausea
43%
decreased libido (men)
43%
sexual dysfunction (men)
33%
fatigue
28%
sweating
28%
constipation
28%
somnolence
28%
decreased appetite
28%
dry mouth
28%
urinary dysfunction
28%
diarrhea
28%
tremor
27%
decreased libido (women)
22%
forgetfulness
22%
lightheadedness
22%
impaired concentration
18%
sexual dysfunction (women)
17%
heartburn
17%
apathy
17%
emesis
17%
headache
11%
insomnia
11%
increased appetite
11%
incoordination
11%
blurry vision
6%
restlessness
6%
nervousness
6%
skin problems
6%
bruising
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertraline and Sugar Pill
Sertraline and Mirtazapine
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MZP+TAUExperimental Treatment1 Intervention
Mirtazapine + Treatment as Usual
Group II: PLO+TAUPlacebo Group1 Intervention
Placebo + Treatment as Usual
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirtazapine
2012
Completed Phase 4
~374070
Find a Location
Who is running the clinical trial?
Washington State UniversityLead Sponsor
109 Previous Clinical Trials
57,611 Total Patients Enrolled
Sterling M McPherson, PhDPrincipal InvestigatorWashington State University
2 Previous Clinical Trials
330 Total Patients Enrolled