BridgeMD
New treatment option for Methamphetamine Abuse
Official title Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users
ClinicalTrials.gov ID: NCT05854667
What this study is testing
What is Treatment as Usual plus lisdexamfetamine (LDX-01)?
Treatment as Usual plus lisdexamfetamine (LDX-01) is an investigational medicine, given as an once-weekly, being studied as a potential treatment for methamphetamine abuse.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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;
You likely can't join if
- 1\. Symptomatic or advanced cardiovascular disease (e.g., advanced arteriosclerosis), moderate hypertension; current hyperthyroidism confirmed via...
See the full eligibility criteria
- 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:
- 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...
- 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 assigned by chance 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.
- 1\. Symptomatic or advanced cardiovascular disease (e.g., advanced arteriosclerosis), moderate hypertension; current hyperthyroidism confirmed via blood test; known hypersensitivity or idiosyncrasy to the...
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- Fredericton, New Brunswick, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; Fredericton, New Brunswick, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.