RecruitingPHASE2INTERVENTIONAL

Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users

This UK-based study is exploring better ways to help adults who use methamphetamine. Researchers want to find out if a high dose of a stimulant medicine, called lisdexamfetamine, can help people reduce their methamphetamine use. They are also testing if combining this medicine with a 'reward programme' makes treatment even more effective. Participants will be placed into one of four groups, and some will receive the new medicine or the reward programme, and some will receive a dummy pill or just the usual care. The aim is to see if these new approaches can help reduce how often people use methamphetamine more effectively than current treatments.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

440

Start

05 Dec 2023

Estimated completion

01 Apr 2028

Methamphetamine Abuse Methamphetamine-dependence Addiction, Substance Addiction

What is this study about?

This study is a clinical trial looking into new and potentially more effective ways to help adults who are struggling with methamphetamine use. Many people find it hard to stop or cut down on methamphetamine, and researchers are always trying to find better treatments. This particular study is investigating a stimulant medication, lisdexamfetamine, which is already used for other conditions, to see if a higher dose can help people reduce their methamphetamine use.

They're also looking at something called 'Contingency Management'. This is a type of programme where people receive rewards for meeting certain goals, such as staying off methamphetamine. The study wants to know if combining this reward system with the medication, or using either approach on its own, is more helpful than the standard treatment offered by clinics.

Understanding if these treatments work better could lead to improved support for people facing methamphetamine dependence. The study compares different approaches to see which one, or which combination, is most effective in helping people reduce how often they use methamphetamine.

Key takeaways

This study is testing new treatments for methamphetamine use.
It involves a stimulant medicine and a reward-based programme.
Participation includes weekly clinic visits and bi-weekly study appointments.
You will be randomly assigned to one of four treatment groups.
The study aims to see if these new approaches help reduce methamphetamine use.
You can leave the study at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 55 years old who has been diagnosed with a moderate to severe methamphetamine use disorder. You should also be actively using methamphetamine, specifically at least 14 days in the past month, and be interested in cutting down or stopping its use. Women who could become pregnant must use reliable birth control during the study.

However, there are some reasons why you might not be able to take part. For example, if you have serious heart problems, an overactive thyroid, glaucoma, or a severe allergy to certain medications. Also, if you have other severe or unstable drug use problems, or certain serious mental health conditions like bipolar disorder, you might not be eligible. The study doctor will carefully check to make sure it's safe for you to take part.

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?
Have you used methamphetamine at least 14 days in the past month?
Are you interested in reducing or stopping your methamphetamine use?
If you are a woman who could get pregnant, are you willing to use birth control during the study?
Do you have any serious heart conditions or other severe health issues that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for a total of 20 weeks. For the first 15 weeks, you'll visit the clinic weekly to receive either the study medication (lisdexamfetamine) or a dummy pill (placebo). You'll also attend weekly treatment sessions.

In addition to these weekly visits, you'll need to come to the clinic every two weeks for study check-ups. These check-ups will take about an hour each time. During these appointments, you'll be asked to provide a urine sample and complete some questionnaires about your health and drug use. You'll be randomly placed into one of four groups: some will get the usual treatment plus a dummy pill, some will get the usual treatment plus a dummy pill and a special reward programme, some will get the usual treatment plus the study medication, and some will get the usual treatment plus the study medication and the reward programme.

Potential risks and benefits

Taking part in this study might offer a potential benefit by giving you access to new treatments that could help you reduce your methamphetamine use. However, as with any medication, there could be side effects. Participants receiving a dummy pill will not receive the active study medication. The study team will explain all known risks before you agree to participate. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Rapid Access Addiction Medicine Clinic, St. Paul's Hospital
Verified postcode
Vancouver, Canada· Recruiting
River Stone Recovery Centre
Verified postcode
Fredericton, Canada· Suspended
Center for Addiction and Mental Health
Verified postcode
Toronto, Canada· Recruiting
University of Montreal Hospital Research Center
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is methamphetamine?

Methamphetamine is a powerful and highly addictive stimulant drug that affects the central nervous system.

What does 'Contingency Management' mean?

It's a programme where you receive rewards, like vouchers or privileges, for reaching certain goals, such as negative drug tests.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real medication but contains no active ingredients. It helps researchers understand if the new medicine is truly effective.

Will I know which treatment group I'm in?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're receiving the active medication or the placebo until the study is over. However, if you are in a group with the reward programme, you will know about that part of the treatment.

What happens if I want to stop taking part?

You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Devon Blanchette

dblanchette@changemark.ca 780-953-6630 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.