M3 is a Phase I clinical trial looking at the safety of offering Mirtazapine, a medication approved to treat
depression, to people who use methamphetamine. Study participants will be closely monitored for 14
days in a hospital setting to evaluate the safety of taking Mirtazapine while using methamphetamine.
Mirtazapine (Remeron©) has shown promise in helping people reduce their use of methamphetamine
and cope with the effects of withdrawal and cravings for meth. It is not currently FDA-approved for this
purpose and this study will help to further evaluate its safety.
Methadone too! Some of the study participants will also be taking methadone to make sure that mirtazapine is safe with both methamphetamine and opioids.
There are medications to help people reduce tobacco use, alcohol use, and opioid use. These options
mean that doctors can prescribe medications to people who are experiencing problems related to their
substance use – just like when someone has diabetes and they need treatment for high blood sugar.
Unfortunately, there are no FDA-approved medications to help people who want to reduce
methamphetamine use. This study is a critical step in changing that.
Your time and contribution are of tremendous value to public health research. Participants who are
eligible and enroll, will be compensated up to $2430 for completing all study activities and procedures.
We know… A two-week hospital stay is a big commitment! FDA trials move in 3 phases before a drug can
be approved for general use. The first phase looks intensively at how the drug works in the body – to
make sure that it is safe in different situations. To do this phase right, study participants will need to be
in an environment where they can be observed continuously. Study staff will do everything we can to
make the time you spend in the hospital pleasant, productive, and personalized for your needs.