Recruiting
Phase 2

Lisdexamfetamine & Contingency Management

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05854667

Conditions

Methamphetamine Abuse

Methamphetamine-dependence

Addiction, Substance

Addiction

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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.

The main questions the trial aims to answer are:

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.

Conditions

Methamphetamine Abuse

Methamphetamine-dependence

Addiction, Substance

Addiction

Study ID

NCT05854667

Start date

Dec 5, 2023

Status verified date

Dec, 2025

Completion date

Apr, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participant must meet all the following criteria:

1. Between 18 and 55 years of age;
2. 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;
3. 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;
4. Interested in reducing/stopping MA use;
5. If female:

1. 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
2. Be of childbearing potential, have a negative pregnancy test at screening, and agree to use an acceptable method of birth control throughout the study;
6. Willing to be randomized to one of the 4 study arms and followed for the duration of the trial;
7. Able to provide informed consent;
8. Willing to comply with study procedures;
9. Able to communicate in English or French.

Exclusion Criteria:

  • 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

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Treatment as Usual plus Placebo

Participants will receive treatment as usual at the clinic as well as once daily lisdexamfetamine matched Placebo orally for 15 weeks.

placebo comparator: Treatment as Usual plus Placebo plus Contingency Management

Participants 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.

active comparator: Treatment as Usual plus lisdexamfetamine (LDX-01)

Participants will receive treatment as usual at the clinic as well as once daily over-encapsulated lisdexamfetamine (LDX-01) orally for 15 weeks.

active comparator: Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management

Participants 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.

Interventions

Treatment as Usual plus Placebo

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 Management

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)

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 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.

Primary outcome measure

  • Total number of days of methamphetamine use during maintenance phase [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Devon Blanchette

780-953-6630dblanchette@changemark.ca

Amina Sow

438 860 2452amina.sow.chum@ssss.gouv.qc.ca

Locations

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

Recruiting

Vancouver, British Columbia, Canada

Contacts

Sahar Reseach Coordinator

sahar.shahidi@bccsu.ubc.ca

Principal Investigator:

Paxton Bach, MD

Center for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1HN

Contacts

Christine Ibrahim

416-535-8501christine.ibrahim@camh.ca

Principal Investigator:

Bernard Le Foll, MD

University of Montreal Hospital Research Center

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Amina Sow, Ph.D

438-860-2452amina.sow.chum@ssss.gouv.qc.ca

Heidar Sharafi, Ph.D

438 860 2452heidar.sharafi.chum@ssss.gouv.qc.ca

Principal Investigator:

Didier Jutras-Aswad, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Feb 5, 2026

Last verified

Dec, 2025

Keywords

  • Contingency Management
  • Treatment as Usual

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-02-05.