Methamphetamine AbusePhase 2NCT06788587
Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
A Phase 2 study testing LDX-01 plus TAU in people with Methamphetamine Abuse and Methamphetamine-dependence, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Methamphetamine Abuse, Methamphetamine-dependence, Addiction
- What is being tested?
- LDX-01 plus TAU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jul 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
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- 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;
- Willing to be randomized 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
Who cannot join
- 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;
- 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;
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- 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 participant at the discretion of the study physician;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
Amina Sow, Ph.D, 438-860-2452, amina.sow.chum@ssss.gouv.qc.ca
Heidar Sharafi, Ph.D, heidar.sharafi.chum@ssss.gouv.qc.ca
About this study
Official title: Exploring Feasibility and Acceptability of Prolonged Administration of High-Dose Stimulants in People With Methamphetamine Use Disorder: An Extension of a Randomized, Placebo-Controlled Trial
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.
The goal of this clinical trial is to evaluate the feasibility of a long-term (25 weeks) administration of high-dose stimulant agonist therapy, using Lisdexamfetamine (LDX-01) on top of treatment-as-usual (TAU), in a population of people with moderate to severe MUD, as measured by study retention, treatment retention, treatment adherence and satisfaction compared against a placebo group.
Read more
Participants will be placed randomly into one of two groups:
- TAU and high-dose LDX-01
- TAU and placebo
Read the detailed description
This trial is a single-centre, randomized double-blind (LDX-01), dose-ascending, placebo-controlled trial. This study is an extension to a parent trial, Addition of high-dose stimulant and engagement-focused contingency management, alone and in combination, to treatment as usual for the management of methamphetamine use disorder (ASCME): a pan-Canadian multi-centre, randomized, controlled trial (NCT05854667). Participants will be enrolled in one of the 2 treatment arms:
Arm 1 : TAU plus high-dose LDX-01 Arm 2 : TAU plus placebo
The trial will enroll 62-80 participants who have completed the parent trial in the Quebec site. The participants will be enrolled in the trial for 30 weeks.
Participation includes the following:
- Participants will receive medication or placebo weekly for 25 weeks
- Participants will attend the clinic for weekly treatment
- Participants will attend the clinic once every week for study visits. At these visits, participants will be asked to provide a urine sample (Weeks 1-25: every two weeks, week 26 and week 30) and/or complete questionnaires
- Conditions
- Methamphetamine Abuse, Methamphetamine-dependence, Addiction, Substance Abuse, Methamphetamine Use Disorder
- Being tested
- LDX-01 plus TAU, Placebo plus TAU
- Keywords
- Substance use disorder, Amphetamines, Methamphetamine, Lisdexamfetamine, Treatment, Agonist therapy, Feasibility
- Medical subject headings
- Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDX-01 plus TAUDrug
Participants receive once daily LDX-01 for 25 weeks, as well as TAU at a clinical site. Medication is provided in 3 phases:
Week 1 (Induction Phase): 100 mg (Days 1 and 2), 150 mg (Days 3 and 4), 200 mg (Days 5, 6 and 7); Weeks 2-21 (Maintenance Phase): 250 mg (or the maximum tolerated for each individual) ; Weeks 22-25 (Taper Phase): 200 mg (Week 22), 150 mg (Week 23), 100 mg (Week 24) and 50 mg (Week 25).
Placebo plus TAUDrug
Participants receive once daily LDX-01-matched placebo for 25 weeks, as well as TAU at a clinical site. Medication is provided in 3 phases:
Week 1 (Induction Phase): 100 mg (Days 1 and 2), 150 mg (Days 3 and 4), 200 mg (Days 5, 6 and 7); Weeks 2-21 (Maintenance Phase): 250 mg (or the maximum tolerated for each individual) ; Weeks 22-25 (Taper Phase): 200 mg (Week 22), 150 mg (Week 23), 100 mg (Week 24) and 50 mg (Week 25).
| Study group | Role | What they receive |
|---|---|---|
| LDX-01 + TAU | Experimental | Participants will receive TAU at the clinic as well as once daily over-encapsulated LDX-01 orally for 25 weeks. Receives: Drug: LDX-01 plus TAU |
| Placebo + TAU | Placebo comparator | Participants will receive TAU at the clinic as well as once daily LDX-01-matched placebo orally for 25 weeks. Receives: Drug: Placebo plus TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in treatment
Retention in treatment will be measured as the proportion of study participants who receive any intervention during the 4 weeks before week 22 and 4 weeks before week 26
Measured: Weeks 18, 19, 20, 21 and weeks 22, 23, 24, 25
Treatment satisfaction
Participant treatment satisfaction will be measured by evaluating participant satisfaction using the Client Satisfaction Questionnaire-8 (CSQ-8) questionnaire. The total score ranges from 8 (minimum) to 32 (maximum) with the higher values showing greater satisfaction.
Measured: Weeks 22, 26
Retention in study
Retention in study will be measured as 1) the proportion of study participants who return for the study visit at week 22 with or without receiving the study interventions, 2) the proportion of study participants who return for the study visit at week 26 with or without receiving the study interventions, and 3) the proportion of study participants who return for the last study visit at week 30 with or without receiving the study interventions.
Measured: Weeks 22, 26 and 30
Treatment adherence
Treatment adherence will be first, measured individually, as the total proportion of the number of the assigned medications (LDX-01/placebo) taken through the intervention (from baseline until the end of week 25) and then averaged across all study completers.
Measured: from week 1 day 1 to week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start18 Jul 2025
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, 2-arm, randomized, double-blind, dose-ascending, placebo-controlled extension trial. Participants will be enrolled into one of 2 treatment arms: * Arm 1: LDX-01 + TAU * Arm 2: Placebo + TAU
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux, Health Canada
- Responsible party
- Sponsor
- Investigators
- Didier Jutras-Aswad, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788587
- Sponsor's protocol ID
- 2025_12643
- Other IDs
- 2025
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Feasibility and Acceptability of Prolonged Administration of High-Dose Stimulants in People With Methamphetamine Use Disorder: An Extension of a Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06788587
- Acronym / sponsor ID
- 2025_12643
- Conditions
- Methamphetamine Abuse, Methamphetamine-dependence, Addiction, Substance Abuse, Methamphetamine Use Disorder
- Keywords
- Substance use disorder, Amphetamines, Methamphetamine, Lisdexamfetamine, Treatment, Agonist therapy, Feasibility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Ministere de la Sante et des Services Sociaux, Health Canada
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The goal of this clinical trial is to evaluate the feasibility of a long-term (25 weeks) administration of high-dose stimulant agonist therapy, using Lisdexamfetamine (LDX-01) on top of treatment-as-usual (TAU), in a population of people with moderate to severe MUD, as measured by study retention, treatment retention, treatment adherence and satisfaction compared against a placebo group.
Participants will be placed randomly into one of two groups:
- TAU and high-dose LDX-01
- TAU and placebo
Detailed description
This trial is a single-centre, randomized double-blind (LDX-01), dose-ascending, placebo-controlled trial. This study is an extension to a parent trial, Addition of high-dose stimulant and engagement-focused contingency management, alone and in combination, to treatment as usual for the management of methamphetamine use disorder (ASCME): a pan-Canadian multi-centre, randomized, controlled trial (NCT05854667). Participants will be enrolled in one of the 2 treatment arms:
Arm 1 : TAU plus high-dose LDX-01 Arm 2 : TAU plus placebo
The trial will enroll 62-80 participants who have completed the parent trial in the Quebec site. The participants will be enrolled in the trial for 30 weeks.
Participation includes the following:
- Participants will receive medication or placebo weekly for 25 weeks
- Participants will attend the clinic for weekly treatment
- Participants will attend the clinic once every week for study visits. At these visits, participants will be asked to provide a urine sample (Weeks 1-25: every two weeks, week 26 and week 30) and/or complete questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre, 2-arm, randomized, double-blind, dose-ascending, placebo-controlled extension trial. Participants will be enrolled into one of 2 treatment arms: * Arm 1: LDX-01 + TAU * Arm 2: Placebo + TAU
| Arm | Type | Receives |
|---|---|---|
| LDX-01 + TAU | Experimental | Drug: LDX-01 plus TAUParticipants will receive TAU at the clinic as well as once daily over-encapsulated LDX-01 orally for 25 weeks. |
| Placebo + TAU | Placebo comparator | Drug: Placebo plus TAUParticipants will receive TAU at the clinic as well as once daily LDX-01-matched placebo orally for 25 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LDX-01 plus TAUParticipants receive once daily LDX-01 for 25 weeks, as well as TAU at a clinical site. Medication is provided in 3 phases: Week 1 (Induction Phase): 100 mg (Days 1 and 2), 150 mg (Days 3 and 4), 200 mg (Days 5, 6 and 7); Weeks 2-21 (Maintenance Phase): 250 mg (or the maximum tolerated for each individual) ; Weeks 22-25 (Taper Phase): 200 mg (Week 22), 150 mg (Week 23), 100 mg (Week 24) and 50 mg (Week 25). | Drug | LDX-01 + TAU |
| Placebo plus TAUParticipants receive once daily LDX-01-matched placebo for 25 weeks, as well as TAU at a clinical site. Medication is provided in 3 phases: Week 1 (Induction Phase): 100 mg (Days 1 and 2), 150 mg (Days 3 and 4), 200 mg (Days 5, 6 and 7); Weeks 2-21 (Maintenance Phase): 250 mg (or the maximum tolerated for each individual) ; Weeks 22-25 (Taper Phase): 200 mg (Week 22), 150 mg (Week 23), 100 mg (Week 24) and 50 mg (Week 25). | Drug | Placebo + TAU |
Primary outcome
Retention in treatment
Time frame: Weeks 18, 19, 20, 21 and weeks 22, 23, 24, 25
Retention in treatment will be measured as the proportion of study participants who receive any intervention during the 4 weeks before week 22 and 4 weeks before week 26
Treatment satisfaction
Time frame: Weeks 22, 26
Participant treatment satisfaction will be measured by evaluating participant satisfaction using the Client Satisfaction Questionnaire-8 (CSQ-8) questionnaire. The total score ranges from 8 (minimum) to 32 (maximum) with the higher values showing greater satisfaction.
Retention in study
Time frame: Weeks 22, 26 and 30
Retention in study will be measured as 1) the proportion of study participants who return for the study visit at week 22 with or without receiving the study interventions, 2) the proportion of study participants who return for the study visit at week 26 with or without receiving the study interventions, and 3) the proportion of study participants who return for the last study visit at week 30 with or without receiving the study interventions.
Treatment adherence
Time frame: from week 1 day 1 to week 25
Treatment adherence will be first, measured individually, as the total proportion of the number of the assigned medications (LDX-01/placebo) taken through the intervention (from baseline until the end of week 25) and then averaged across all study completers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Didier Jutras-Aswad, MD principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LDX-01 plus TAU in people with Methamphetamine Abuse and Methamphetamine-dependence, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devon Blanchette (780-953-6630, dblanchette@changemark.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in treatment (time frame: Weeks 18, 19, 20, 21 and weeks 22, 23, 24, 25). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.