Clinical trial 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)?
This is an investigational daily pill being studied to see if it helps reduce methamphetamine use. It is designed to increase levels of certain brain chemicals that affect mood and focus.
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
- This study wants to find out if a high-dose stimulant medication, with or without a reward system, helps people use methamphetamine less often than standard care alone.
- Who it's for
- The study is looking for adults who use methamphetamine.
- What's involved
- Participants will get a weekly pill (either the study drug or a sugar pill) and attend regular clinic visits. They will also provide urine samples and fill out questionnaires at check-ups.
- Time commitment
- The study lasts 15 weeks and requires weekly treatment visits plus a study visit every two weeks.
- 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
- 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;
- Be of non-childbearing potential, defined as (i) postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)
You likely can't join if
- 1\. Symptomatic or advanced cardiovascular disease (e.g., advanced arteriosclerosis), moderate hypertension
See the full eligibility 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;
- Be of non-childbearing potential, defined as (i) postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Vancouver, British Columbia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.