Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
This study is investigating if a higher dose of a stimulant medication, called LDX-01, can make it easier for people with moderate to severe methamphetamine use disorder to stay in treatment long-term. Methamphetamine use disorder is a growing health concern. While some stimulant medicines show promise, we don't know much about using them as a long-term treatment. Participants will receive their usual care, plus either the study medication (LDX-01) or a placebo (a dummy pill, with no active medicine) for 25 weeks. The study wants to see how well people stick with the treatment and their overall satisfaction, to understand if this approach is practical for future use.
At a glance
What is this study about?
This study is looking into a new way to help people who have problems with methamphetamine use. This is becoming a bigger health concern in many places. You might know methamphetamine as 'crystal meth' or 'ice'. Doctors are trying to find out if giving a special stimulant medicine, called LDX-01, at a higher dose and for a longer time (about 25 weeks) can help people stay in treatment for their methamphetamine use disorder.
At the moment, we don't have a lot of information about using stimulant medicines for a long period to help people manage methamphetamine use disorder. This study wants to see if this approach is practical and if people find it helpful enough to stick with it. It will compare the active medicine (LDX-01) with a dummy pill (called a 'placebo') to understand the real effects.
Understanding how well people stay in treatment, how they follow instructions, and how they feel about the treatment will give doctors valuable information. This could help shape future treatments for methamphetamine use disorder, aiming to provide better and more lasting support for those who need it.
Key takeaways
- This study explores a long-term stimulant treatment for methamphetamine use disorder.
- It compares the medicine LDX-01 with a dummy pill (placebo).
- Participation involves weekly clinic visits for treatment and study assessments.
- The study lasts about 30 weeks, with medicine given for 25 weeks.
- Your eligibility depends on your age, previous study participation, and health conditions.
- You can withdraw from the study at any time.
Who may be eligible?
To be part of this study, you need to be between 18 and 55 years old and have been diagnosed with moderate to severe methamphetamine use disorder. You must have already taken part in a previous related study called ASCME and completed it up to a certain point.
It's important that you want to reduce your methamphetamine use, stop using it, or avoid going back to using it. The study doctors will also need to agree that you would benefit from extra treatment for your methamphetamine use. If you are a woman who could become pregnant, you'll need to use reliable birth control during the study or meet certain criteria (like being past menopause or having had surgery to prevent pregnancy).
You won't be able to join if you have serious heart problems, high blood pressure that isn't controlled, an overactive thyroid, or certain eye conditions like glaucoma. Also, if you have other serious drug use problems that could make it unsafe for you to take part, or if you are using certain medications for opioid use disorder, you won't be eligible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 55 years old?
- Have you been diagnosed with moderate to severe methamphetamine use disorder?
- Did you complete the previous ASCME study up to Week 20?
- Are you willing to reduce or stop your methamphetamine use?
- Are you able to attend weekly clinic visits?
- Do you have any serious heart conditions or uncontrolled high blood pressure?
What does participation involve?
If you join this study, you will be in it for about 30 weeks. You'll be placed into one of two groups by chance: one group will receive the study medicine (LDX-01) and your usual care, while the other group will receive a dummy pill (placebo) along with your usual care. You won't know which group you are in, and neither will your study doctor.
You will receive your medication or placebo every week for 25 weeks. This means you will need to come to the clinic every week for treatment. On top of this, you will also have study visits at the clinic once a week. During these visits, you'll be asked to provide urine samples regularly (every two weeks for the first 25 weeks, then at week 26 and week 30) and fill out questionnaires about how you are doing.
Potential risks and benefits
Locations (1)
- Centre hospitalier de l'Université de Montréal (CHUM)Verified postcodeMontreal, Canada· Recruiting
Common questions
What is LDX-01?
LDX-01 is a stimulant medication that is being tested in this study to see if it can help people with methamphetamine use disorder.
What is a 'placebo'?
A placebo is a dummy pill that looks like the study medicine but contains no active ingredients. It helps us compare the effects of the real medicine.
Will I know if I'm getting the real medicine or the placebo?
Neither you nor the study doctors will know if you are receiving LDX-01 or the placebo. This is called a 'double-blind' study and helps ensure fair results.
How long will I be in the study?
You will be in the study for a total of 30 weeks, which includes receiving medication or placebo for 25 weeks and follow-up visits.
What does 'TAU' mean?
TAU stands for 'Treatment As Usual'. This means you will continue to receive the standard care for your methamphetamine use disorder, regardless of which study group you are in.
How to find out more
Devon Blanchette
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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