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New treatment option for Methamphetamine Abuse
Official title Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
ClinicalTrials.gov ID: NCT06788587
What this study is testing
What is LDX-01 plus TAU?
LDX-01 plus TAU is an investigational medicine, given as an once-weekly, being studied as a potential treatment for methamphetamine abuse.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Methamphetamine use disorder (MUD) is becoming an increasing public health concern in Canada. While the evidence on the efficacy and safety of prescription psychostimulants for the treatment of MUD is promising, the knowledge on the maintenance therapy using stimulant agonist therapy is scarce and needs further investigation, especially in terms of long-term retention in treatment.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Between 18 and 55 years of age at enrollment in the parent ASCME trial;
- Diagnosed with a moderate to severe MUD as defined by the DSM-5 criteria;
- Enrolled in the parent ASCME trial and completed the study up to and including the end of study visit at Week 20, Day 1;
- Interested in avoiding relapse, decreasing methamphetamine use, or abstaining from methamphetamine use;
- Presence of ongoing substance use, craving, or significant risk of relapse that according to the study physician, warrants extended treatment for MUD;
You likely can't join if
- Symptomatic or advanced cardiovascular disease (e.g., advanced arteriosclerosis), moderate hypertension; confirmed current hyperthyroidism; known...
- Any severe or unstable co-morbid substance use disorder that, in the opinion of the study physician, precludes safe participation in the study;
- 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...
- Current or a history of any serious psychiatric disorder (e.g., bipolar disorder, pre-existing psychosis, schizophrenia) that, in the opinion of the...
- History of a SAE, hypersensitivity or known allergic reaction to LDX-01 or other amphetamine drugs, or hypersensitivity to the sympathomimetic amines;
- Pregnant, nursing, or planning to become pregnant during the study period;
See the full eligibility criteria
- Between 18 and 55 years of age at enrollment in the parent ASCME trial;
- Diagnosed with a moderate to severe MUD as defined by the DSM-5 criteria;
- Enrolled in the parent ASCME trial and completed the study up to and including the end of study visit at Week 20, Day 1;
- Interested in avoiding relapse, decreasing methamphetamine use, or abstaining from methamphetamine use;
- Presence of ongoing substance use, craving, or significant risk of relapse that according to the study physician, warrants extended treatment for MUD;
- 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...
- Be of childbearing potential, have a negative pregnancy test at screening, and agree to use an acceptable method of birth control throughout the study;
- Willing to be assigned by chance to one of 2 study arms and followed for the duration of the trial;
- Able to start the study intervention within 28 days after completing the ASCME main trial (study no. CRISM-002);
- Able to provide informed consent;
- Willing to comply with study procedures;
- Able to communicate in English or French
- Symptomatic or advanced cardiovascular disease (e.g., advanced arteriosclerosis), moderate hypertension; confirmed current hyperthyroidism; known hypersensitivity or idiosyncrasy to the sympathomimetic amines or...
- Any severe or unstable co-morbid substance use disorder that, in the opinion of the study physician, precludes safe participation in the study;
- 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;
- 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;
- History of a SAE, hypersensitivity or known allergic reaction to LDX-01 or other amphetamine drugs, or hypersensitivity to the sympathomimetic amines;
- Pregnant, nursing, or planning to become pregnant during the study period;
- 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;
- 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;
- 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;
- 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...
- 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;
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.