High dose stimulant treatment for methamphetamine users

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Didier Jutras-Aswad — University of Montreal Hospital Research Center
• Study coordinator: Devon Blanchette
• Email: dblanchette@changemark.ca
• Phone: 780-953-6630

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term high-dose lisdexamfetamine treatment for methamphetamine use disorder

  This trial will try giving adults with moderate to severe methamphetamine use disorder a 25-week course of high-dose lisdexamfetamine plus their usual care to see if it helps them stay in treatment and cut down on methamphetamine use compared with placebo.

  Recruiting Phase 2 Centre hospitalier de l'Université de Montréal (CHUM) · Montreal, Quebec · NCT06788587

• Brain imaging to predict teens' response to cannabis treatment

  This project will test whether teens' brain activity during a learning task can predict how well 14–17-year-olds do in a 10-week virtual reward program to reduce cannabis use.

  Recruiting Indiana University · Indianapolis, Indiana · NCT07340554

• Using brain stimulation to reduce cravings in methamphetamine users

  This study tests whether a type of brain stimulation can help reduce cravings for methamphetamine in adults who are trying to stay off the drug.

  Recruiting Oregon Health and Science University · Portland, Oregon · NCT03470480

• Vocal Signals of Craving in Addiction

  Researchers will see if voice patterns can signal craving in adults with addictions by having them perform voice tasks and report their cravings in real time.

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• Impact of GLP-1 Receptor Agonist Therapy vs Structured Lifestyle on Weight and Health

  This study tests whether starting a GLP-1 receptor agonist for weight loss works differently from a structured diet-and-exercise program in improving heart and metabolic health for adults with overweight or obesity.

  Recruiting Texas Tech University · Lubbock, Texas · NCT07740291

• Craving and addiction severity: how craving links to changing levels of addiction in daily life

  This observational study tests whether craving and the way different addiction symptoms interact can predict changes in addiction severity over two years for adults with substance use disorders.

  Recruiting University of Bordeaux · Bordeaux · NCT07734363

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.