High dose stimulant treatment for methamphetamine users

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

This study is testing whether a high dose of a medication called lisdexamfetamine, along with support and rewards, can help adults who use methamphetamine reduce their drug use more effectively than standard treatment alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 440 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Academic / other)
• Locations: 4 sites (Vancouver, British Columbia and 3 other locations)
• Trial ID: NCT05854667 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of high-dose lisdexamfetamine combined with contingency management in reducing methamphetamine use among adults. Participants will be randomly assigned to one of four groups, receiving either usual treatment with a placebo or lisdexamfetamine, with or without contingency management. The trial will last for 20 weeks, during which participants will receive weekly medication and attend weekly clinic visits. The study seeks to determine if the combination of high-dose stimulant and contingency management is more effective than standard treatment alone.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 diagnosed with moderate to severe methamphetamine use disorder who are actively using methamphetamine and are interested in reducing or stopping their use.

Not a fit: Patients who do not meet the age or diagnostic criteria, or those who are not actively using methamphetamine, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce methamphetamine use and improve recovery outcomes for patients struggling with addiction.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination of high-dose stimulant and contingency management is being evaluated for the first time.

Eligibility criteria

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

Where this trial is running

Vancouver, British Columbia and 3 other locations

• Rapid Access Addiction Medicine Clinic, St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
• River Stone Recovery Centre — Fredericton, New Brunswick, Canada (Suspended)
• Center for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
• University of Montreal Hospital Research Center — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Didier Jutras-Aswad — University of Montreal Hospital Research Center
• Study coordinator: Devon Blanchette

Conditions Methamphetamine Abuse; Methamphetamine-dependence; Addiction, Substance; Addiction; Contingency Management; Treatment as Usual