Lisdexamfetamine for Methamphetamine Addiction

Recruiting in Palo Alto (17 mi)

Overseen byDidier Jutras-Aswad, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Prior Safety Data

Trial Summary

What is the purpose of this trial?Methamphetamine use disorder (MUD) is becoming an increasing public health concern in Canada. While the evidence on the efficacy and safety of prescription psychostimulants for the treatment of MUD is promising, the knowledge on the maintenance therapy using stimulant agonist therapy is scarce and needs further investigation, especially in terms of long-term retention in treatment. The goal of this clinical trial is to evaluate the feasibility of a long-term (25 weeks) administration of high-dose stimulant agonist therapy, using Lisdexamfetamine (LDX-01) on top of treatment-as-usual (TAU), in a population of people with moderate to severe MUD, as measured by study retention, treatment retention, treatment adherence and satisfaction compared against a placebo group. Participants will be placed randomly into one of two groups: 1. TAU and high-dose LDX-01 2. TAU and placebo

Eligibility Criteria

This trial is for individuals with moderate to severe methamphetamine use disorder (MUD) in Canada. Participants should be interested in a long-term treatment plan and willing to adhere to the study's procedures. Specific eligibility criteria are not provided, but typically include age range, health status, and absence of conflicting conditions or treatments.

Inclusion Criteria

I am not able to become pregnant or will use birth control during the study.

Willing to be randomized to one of 2 study arms and followed for the duration of the trial

I can communicate in English or French.

+8 more

Exclusion Criteria

Pregnant, nursing, or planning to become pregnant during the study period

Planned extended absence during the study period that might prevent completion of the study

Current or a history of any serious psychiatric disorder that precludes safe participation in the study

+10 more

Participant Groups

The trial tests if high-dose Lisdexamfetamine (LDX-01), alongside usual treatment (TAU), can help people with MUD over 25 weeks. It compares this approach against a placebo plus TAU group. The focus is on retention in treatment, adherence, and satisfaction.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LDX-01 + TAUExperimental Treatment1 Intervention

Participants will receive TAU at the clinic as well as once daily over-encapsulated LDX-01 orally for 25 weeks.

Group II: Placebo + TAUPlacebo Group1 Intervention

Participants will receive TAU at the clinic as well as once daily LDX-01-matched placebo orally for 25 weeks.