Methamphetamine Abuse study: LDX-01 plus TAU
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, 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
- The study aims to see if a 25‑week course of high‑dose lisdexamfetamine is feasible for people with methamphetamine use disorder, measuring how many stay in treatment, follow the medication schedule, and are satisfied, compared with a placebo.
- Who it's for
- Adults who have moderate to severe methamphetamine use disorder.
- What's involved
- Participants are randomly assigned to receive either high‑dose lisdexamfetamine plus standard treatment or a placebo plus standard treatment. They will take the study medication and attend scheduled clinic visits for assessments and safety checks.
- Time commitment
- The trial lasts about 25 weeks and requires regular study visits throughout that period.
- 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
- 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;
- Be of non-childbearing potential, defined as (i) postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)
- 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
- 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 is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.