Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether a long-term treatment with a high dose of a medication called Lisdexamfetamine (LDX-01) can help individuals with moderate to severe methamphetamine use disorder (MUD). The study aims to see how well people can stick to this treatment over 25 weeks compared to those receiving a placebo (a dummy treatment that has no active ingredients). Participants will be randomly assigned to either receive LDX-01 along with standard treatment or just the standard treatment alone. The goal is to understand if this new approach can help more people stay in treatment and reduce their methamphetamine use.

To be eligible for the trial, participants must be between 18 and 55 years old and have a diagnosis of moderate to severe MUD. They should have completed another related study and be interested in reducing or stopping their methamphetamine use. Those who join the study can expect regular check-ins and support as they try this new treatment. It's important to note that people with certain medical conditions or those taking specific medications may not qualify to participate for their safety. This trial is not yet recruiting participants, but it represents a significant step in exploring better treatment options for methamphetamine addiction.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Between 18 and 55 years of age at enrollment in the parent ASCME trial;
• • 2. Diagnosed with a moderate to severe MUD as defined by the DSM-5 criteria;
• • 3. Enrolled in the parent ASCME trial and completed the study up to and including the end of study visit at Week 20, Day 1;
• • 4. Interested in avoiding relapse, decreasing methamphetamine use, or abstaining from methamphetamine use;
• • 5. Presence of ongoing substance use, craving, or significant risk of relapse that according to the study physician, warrants extended treatment for MUD;
• 6. If female:
• • Be of non-childbearing potential, defined as (i) postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age); or (ii) documented surgically sterilized (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or
• • Be of childbearing potential, have a negative pregnancy test at screening, and agree to use an acceptable method of birth control throughout the study;
• • 7. Willing to be randomized to one of 2 study arms and followed for the duration of the trial;
• • 8. Able to start the study intervention within 28 days after completing the ASCME main trial (study no. CRISM-002);
• • 9. Able to provide informed consent;
• • 10. Willing to comply with study procedures;
• • 11. Able to communicate in English or French
• Exclusion Criteria:
• • 1. Symptomatic or advanced cardiovascular disease (e.g., advanced arteriosclerosis), moderate hypertension; confirmed current hyperthyroidism; known hypersensitivity or idiosyncrasy to the sympathomimetic amines or glaucoma or any disabling, severe, or unstable medical condition (including electrolyte disturbances) that, in the opinion of the study physician, precludes safe participation or the ability to provide fully informed consent;
• • 2. Any severe or unstable co-morbid substance use disorder that, in the opinion of the study physician, precludes safe participation in the study;
• • 3. Participants with Opioid Use Disorder (OUD) who have been on Opioid Agonist Treatment (OAT) for \<12 weeks, and not yet at stabilization dose, or at stabilization dose \<4 weeks;
• • 4. Current or a history of any serious psychiatric disorder (e.g., bipolar disorder, pre-existing psychosis, schizophrenia) that, in the opinion of the study physician, precludes safe participation in the study;
• • 5. History of a SAE, hypersensitivity or known allergic reaction to LDX-01 or other amphetamine drugs, or hypersensitivity to the sympathomimetic amines;
• • 6. Pregnant, nursing, or planning to become pregnant during the study period;
• • 7. Planned extended absence during the study period (e.g., pending legal action, surgery, incarceration, inpatient residential program) in the opinion of the study physician that might prevent completion of the study;
• • 8. Use of an investigational drug for stimulant use disorder during the 30 days before screening, confirmed via self-report or pharmacy records; excluding the use of study medication in the parent ASCME trial;
• • 9. Use of prescribed amphetamine-type medication or medication for the treatment of stimulant use disorder (e.g., methylphenidate, modafinil, bupropion, or mirtazapine) in the 4 weeks before screening;
• • 10. Current or anticipated need for treatment with any medication that may interact with LDX-01 (e.g., monoamine oxidase inhibitors \[MAOIs\]) used currently or within the past 14 days and that would preclude study participant at the discretion of the study physician;
• • 11. ECG measurement (Bazett method for the correction of QT interval) that indicates a prolonged QTc interval (≥460 milliseconds for females and ≥450 milliseconds for males) at screening;
• • 12. Any SAEs related to the study product in the parent trial phase that, in the opinion of the study physician, precludes safe participation in the extension study;
• • 13. Any compliance issues related to the study product and/or study procedures during the parent trial phase that, in the opinion of the study physician, precludes safe participation in the extension study.