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Methamphetamine AbusePhase 2NCT05854667

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

A Phase 2 study testing Treatment as Usual plus lisdexamfetamine (LDX-01) and Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management in people with Methamphetamine Abuse and Methamphetamine-dependence, run by Centre hospitalier de l'Université de Montréal (CHUM) at 4 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn if administering a high dose stimulant with Contingency Management reduces days of use in adults who use methamphetamine better than the usual treatment provided by the clinic. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
Treatment as Usual plus lisdexamfetamine (LDX-01) and Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
440 participants
Where
4 sitesCanada
Study dates
5 Dec 2023to Apr 2028
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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant must meet all the following criteria:
  • Between 18 and 55 years of age;
  • Diagnosed with a moderate to severe methamphetamine (MA) use disorder as defined by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria;
  • Active MA use at screening measured via self-reported MA use ≥14 days in the past 28 days AND verified by urine drug metabolite testing;
  • Interested in reducing/stopping MA use;
  • If female:
Show all 12Show fewer
  • 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 the 4 study arms and followed for the duration of the trial;
  • Able to provide informed consent;
  • Willing to comply with study procedures;
  • Able to communicate in English or French.

Who cannot join

  • 1. Symptomatic or advanced cardiovascular disease (e.g., advanced arteriosclerosis), moderate hypertension; current hyperthyroidism confirmed via blood test; known hypersensitivity or idiosyncrasy to the sympathomimetic amines or glaucoma or any disabling, severe, OR unstable medical condition 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 Therapy (OAT) for < 12 weeks, and not yet at stabilization dose, or at stabilization dose < 4 weeks; 4. Current or 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 severe adverse event, hypersensitivity or known allergic reaction to LDX 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 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 prior to screening, confirmed via self-report OR pharmacy records; 9. Currently receiving contingency management for the treatment of stimulant use disorder in the 4 weeks prior to screening, confirmed via self-report OR site records; 10. Use of prescribed amphetamine-type medication OR medication for the treatment of stimulant use disorder (e.g., methylphenidate, modafinil, bupropion) in the 4 weeks prior to screening; 11. Current or anticipated need for treatment with any medication that may interact with LDX (e.g., proton pump inhibitors, 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Devon Blanchette contact

780-953-6630

dblanchette@changemark.ca

Amina Sow contact

438 860 2452

amina.sow.chum@ssss.gouv.qc.ca

Canada4 sites, 3 recruiting

  • River Stone Recovery Centre

    Fredericton, New Brunswick, E3B 1E3

    Suspended

  • University of Montreal Hospital Research Center

    Montreal, Quebec, H2X 0A9

    Amina Sow, Ph.D, 438-860-2452, amina.sow.chum@ssss.gouv.qc.ca

    Heidar Sharafi, Ph.D, 438 860 2452, heidar.sharafi.chum@ssss.gouv.qc.ca

    Recruiting

  • Center for Addiction and Mental Health

    Toronto, Ontario, M6J 1HN

    Christine Ibrahim, 416-535-8501 ext. 39369, christine.ibrahim@camh.ca

    Bernard Le Foll, MD

    Recruiting

  • Rapid Access Addiction Medicine Clinic, St. Paul's Hospital

    Vancouver, British Columbia

    Sahar Reseach Coordinator, sahar.shahidi@bccsu.ubc.ca

    Paxton Bach, MD

    Recruiting

Other trials in Canada

About this study

Official title: Addition of High Dose Stimulant and Engagement-focused Contingency Management (CM), Alone and in Combination, to Treatment as Usual (TAU) for the Management of Methamphetamine (MA) Use Disorder (ASCME): a Canadian Multi-centre, RCT

The goal of this clinical trial is to learn if administering a high dose stimulant with Contingency Management reduces days of use in adults who use methamphetamine better than the usual treatment provided by the clinic.

The main questions the trial aims to answer are:

Read more

Is a high dose stimulant better than a placebo and usual treatment at helping reduce the number of days they use methamphetamine? Is a high dose stimulant with contingency management better than placebo and usual treatment at helping people reduce the number of days they use methamphetamine?

Participants will be placed randomly into one of four groups:

  1. Usual treatment and placebo
  2. Usual treatment, placebo and contingency management
  3. Usual treatment and high dose stimulant
  4. Usual treatment, high dose stimulant and contingency management

Participation includes the following:

  1. Participants will receive medication or placebo weekly for 15 weeks.
  2. Participants will attend the clinic for weekly treatment
  3. Participants will attend the clinic once every 2 weeks for study visits. Each visit will take about an hour to complete. At these visits, participants will be asked to provide a urine sample and complete questionnaires.
Read the detailed description

The ASCME trial is a multi-centre, randomized double blind (lisdexamfetamine-01 component), open label (Contingency Management component), dose-ascending, placebo controlled trial. Participants will be enrolled in one of the 4 treatment arms:

Arm 1: treatment as usual plus placebo Arm 2: treatment as usual plus placebo and contingency management Arm 3: treatment as usual plus lisdexamfetamine (LDX-01) Arm 4: treatment as usual plus lisdexamfetamine (LDX-01) and contingency management

The trial will enroll 440 participants, and will be conducted in 5-7 treatment centres across Canada.

Participants will be enrolled in the trial for 20 weeks altogether.

Being tested
Treatment as Usual plus Placebo, Treatment as Usual plus Placebo plus Contingency Management, Treatment as Usual plus lisdexamfetamine (LDX-01), Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management
Keywords
Contingency Management, Treatment as Usual
Medical subject headings
Substance-Related Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment as Usual plus PlaceboDrug

    Also called Contingency Management

    Participants receive once daily Lisdexamfetamine matched placebo for 15 weeks, as well as treatment as usual at clinical site.

  • Treatment as Usual plus Placebo plus Contingency ManagementDrug

    Participants receive once daily Lisdexamfetamine matched placebo for 15 weeks, as well as treatment as usual at clinical site, and engagement-focused contingency management for 12 weeks, week 2-13.

  • Treatment as Usual plus lisdexamfetamine (LDX-01)Drug

    Participants receive once daily Lisdexamfetamine for 15 weeks, as well as treatment as usual at clinical site. Medication is provided in 3 phases:

    Week 1 (Induction Phase): 100 mg (Day 1 and 2), 150 mg (Day 3 and 4), 200 mg (Day 5, 6 and 7) Weeks 2-13 (Maintenance Phase): 250 mg per day (or the maximum tolerated for each individual) and then will continue on the same daily dose Weeks 14-15 (Taper Phase): 150 mg (Week 14) and 50 mg (Week 15).

  • Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency ManagementDrug

    Also called Contingency Management

    Participants receive once daily Lisdexamfetamine for 15 weeks, as well as treatment as usual at clinical site. Medication is provided in 3 phases:

    Week 1 (Induction Phase): 100 mg (Day 1 and 2), 150 mg (Day 3 and 4), 200 mg (Day 5, 6 and 7) Weeks 2-13 (Maintenance Phase): 250 mg per day (or the maximum tolerated for each individual) and then will continue on the same daily dose Weeks 14-15 (Taper Phase): 150 mg (Week 14) and 50 mg (Week 15). Engagement-focused contingency management will be provided for 12 weeks, Week 2-13.

Study groups in NCT05854667
Study groupRoleWhat they receive
Treatment as Usual plus PlaceboPlacebo comparatorParticipants will receive treatment as usual at the clinic as well as once daily lisdexamfetamine matched Placebo orally for 15 weeks.
Receives: Drug: Treatment as Usual plus Placebo
Treatment as Usual plus Placebo plus Contingency ManagementPlacebo comparatorParticipants will receive treatment as usual at the clinic, once daily lisdexamfetamine matched placebo medication orally for 15 weeks, as well as engagement-focused contingency management.
Receives: Drug: Treatment as Usual plus Placebo plus Contingency Management
Treatment as Usual plus lisdexamfetamine (LDX-01)Active comparatorParticipants will receive treatment as usual at the clinic as well as once daily over-encapsulated lisdexamfetamine (LDX-01) orally for 15 weeks.
Receives: Drug: Treatment as Usual plus lisdexamfetamine (LDX-01)
Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency ManagementActive comparatorParticipants will receive treatment as usual at the clinic, once daily over-encapsulated lisdexamfetamine (LDX-01) orally for 15 weeks, as well as engagement-focused contingency management.
Receives: Drug: Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total number of days of methamphetamine use during maintenance phase

    The primary outcome measure is the total number of days of MA use during the 12-week maintenance treatment period of the trial, assessed via self-report using the Timeline Followback (TLFB) Questionnaire.

    Measured: 12 weeks

Secondary outcomes (7)

  1. Medication Adherence

    Medication adherence will be measured by the number of days the medication is taken as prescribed. The medication is provided to the patient in Blister Packaging, with an electronic data monitoring system affixed. The date and time each dose is taken by participant will be recorded by the electronic blister pack database. This data will be extracted from an Electronic Blister Packaging Database, and pharmacy abstraction. Retention on study medication/placebo will be defined as the proportion of participants (LDX-01 or placebo) at D1 of Week 15, having an active prescription for the treatment, confirmation via self-report by the participant of ingestion of medication/placebo and monitoring of the electronic blister pack.

    Measured: 15 weeks

  2. Safety Events

    Safety in the trial will be evaluated by monitoring adverse events and serious adverse events over the entire course of the study; (i.e., baseline (Day 1), Day 3, and Day 5 of Week 1, and Day 1 of Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 20 (end of follow-up). Adverse events and serious adverse events will be defined and documented according to the adverse reporting procedures.Information regarding safety events will be collected via self-report, report from others, or chart abstraction, or all of the above.

    Measured: 20 weeks

  3. Changes in Quality of Life

    Quality of life will be measured using the WHO Quality of Life-BREF40 which is person-centred generic patient-reported quality of life measure, being validated to document and follow changes in quality of life in different physical and psychiatric disorders. It specifically looks at 4 domains related to quality of life: physical health, psychological health, social relationships, and environment. Quality of Life Assessment will yield data on the number of participants that report more positive quality of life in the domains of physical health, psychological health, social relationships, and environment.

    Measured: Will be administered at Baseline, Week 8, 14 and 20.

  4. Methamphetamine and other Substance Use - self report

    Methamphetamine and other substance use will be measured every two weeks by self report using the time line follow back (TLFB). The TLFB collects self-reported substance use amount, frequency, and duration retrospectively over the past 14 days. The TLFB has shown very good reported psychometric properties in adults using substances.

    Measured: 15 weeks

  5. Methamphetamine and other Substance Use - urine drug screen

    Urine samples for drug screens will be collected at screening, baseline, and every 2 weeks for the 12- week Maintenance Phase, as well during the taper and follow-up phases. All urine specimens will be collected and analysed using Health Canada approved, Rapid Response Multi-Drug One Step Screen Test Panel, and will follow all manufacturer's recommended procedures to test for the presence of the following drugs or their respective metabolites: amphetamine, methamphetamine, morphine, fentanyl, benzodiazepines, cocaine, THC, methadone, buprenorphine, methylphenidate, MDMA, LSD, ketamine, oxycodone, heroin, Hydromorphone. A further validity check will be performed using a commercially available adulterant test strip.

    Measured: 15 weeks

  6. Indigenous wellness perspective

    The Wellness Registry Tool - 10 (WRT-10) aims to capture the voice of Indigenous participants with respect to their own wellness, in a culturally relevant way, with the broader goal to improve mental, physical, emotional, and spiritual wellness. This tool has 3 sections: 1) aspects of balance: physical, mental emotional and spiritual health and well-being, 2) Social connectedness, and 3) participation in cultural practices. Section 1 \& 2 are rated on a 5-point Likert scale and captures how participants rate their overall (holistic) wellbeing, as well as each individual component of their wellbeing. Section 3 captures participant engagement with cultural activities, services, supports, and healing traditions.

    Measured: Administered at Baseline, week 8, 14 and 20

  7. Treatment Satisfaction

    Treatment satisfaction will be assessed using the Client Satisfaction Questionnaire-8 (CSQ-8) and has shown good psychometric properties (Matsubara et al., 2013). The CSQ-8 collects information on the participant's satisfaction as it relates to the assigned medication and the clinical care received at the site.

    Measured: Week 14 only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start5 Dec 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

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
Participants will be randomized to one of four arms: 1. Treatment as Usual with Placebo 2. Treatment as Usual with Placebo and Contingency Management 3. Treatment as Usual with Lisdexamfetamine (LDX-01) 4. Treatment as usual with Lisdexamfetamine (LDX-01) and Contingency Management
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05854667
Sponsor's protocol ID
23.053
Status last verified
Dec 2025
First submitted
6 Apr 2023
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bach P, Le Foll B, Davidson S, de Kiewit A, Bakouni H, Poulin G, Ghosh M, Jutras-Aswad D. A protocol for high-dose lisdexamfetamine and contingency management, alone or in combination, for the treatment of methamphetamine use disorder: The ASCME study. Contemp Clin Trials. 2025 Jun;153:107916. doi: 10.1016/j.cct.2025.107916. Epub 2025 Apr 13.

    PubMed 40233849

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Treatment as Usual plus lisdexamfetamine (LDX-01) and Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management in people with Methamphetamine Abuse and Methamphetamine-dependence, run by Centre hospitalier de l'Université de Montréal (CHUM) at 4 sites 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 12 inclusion and 1 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 5 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 4 sites 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?

Total number of days of methamphetamine use during maintenance phase (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05854667, which also lists 1 linked publication.

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 5 Feb 2026.

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