Clinical trial NCT05854667: Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Methamphetamine Abuse
Methamphetamine-dependence
Addiction, Substance
Addiction
Keywords: Contingency Management
Treatment as Usual
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-05-11
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Total number of days of methamphetamine use during maintenance phase
timeFrame: 12 weeks
Secondary outcomes:
measure: Medication Adherence
timeFrame: 15 weeks
measure: Safety Events
timeFrame: 20 weeks
measure: Changes in Quality of Life
timeFrame: Will be administered at Baseline, Week 8, 14 and 20.
measure: Methamphetamine and other Substance Use - self report
timeFrame: 15 weeks
measure: Methamphetamine and other Substance Use - urine drug screen
timeFrame: 15 weeks
measure: Indigenous wellness perspective
timeFrame: Administered at Baseline, week 8, 14 and 20
measure: Treatment Satisfaction
timeFrame: Week 14 only
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Rapid Access Addiction Medicine Clinic, St. Paul's Hospital
state: British Columbia
city: Fredericton
country: Canada
facility: River Stone Recovery Centre
state: New Brunswick
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health
state: Ontario
city: Montréal
country: Canada
facility: University of Montreal Hospital Research Center
state: Quebec
Study officials:
affiliation: University of Montreal Hospital Research Center
name: Didier Jutras-Aswad
role: PRINCIPAL_INVESTIGATOR
References: