Lisdexamfetamine for Methamphetamine Addiction

Overseen By Pamela Lachance-Touchette, Ph.D

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Amphetamines, MAOIs

Disqualifiers: Cardiovascular disease, Hypertension, Psychiatric disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 27

Duration: 25 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment for methamphetamine addiction using Lisdexamfetamine (LDX-01) to determine its effectiveness in helping individuals adhere to treatment and avoid relapse. Participants will be divided into two groups: one receiving LDX-01 with usual care and the other receiving a placebo with usual care. The trial seeks individuals with moderate to severe methamphetamine use disorder who are concerned about relapsing and wish to reduce or quit methamphetamine use. The research aims to determine if long-term LDX-01 treatment can help individuals remain in treatment and improve recovery chances. As a Phase 2 trial, it focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to significant findings.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot use certain medications like amphetamine-type drugs or those that interact with Lisdexamfetamine (LDX-01) before starting the trial. It's best to discuss your current medications with the study physician to ensure they don't interfere with the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lisdexamfetamine (LDX) is generally safe for people. In studies where adults with methamphetamine addiction took LDX at a dose of 250 mg per day, participants tolerated the treatment well. Another study found that LDX helped with methamphetamine withdrawal without major safety issues. In a different study, only about 5% of participants reported serious side effects when using LDX for methamphetamine use. These findings suggest that LDX is relatively safe, although some side effects can occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for methamphetamine addiction focus on behavioral therapies and counseling, with no specific medications approved for this condition. But LDX-01 offers a fresh approach by using lisdexamfetamine, a prodrug of dextroamphetamine, which targets the brain's dopamine system differently. This unique mechanism could help reduce cravings and withdrawal symptoms more effectively. Researchers are excited because this could potentially fill a significant gap in addiction treatment options.

What evidence suggests that LDX-01 might be an effective treatment for methamphetamine addiction?

Research has shown that lisdexamfetamine can reduce methamphetamine use. In earlier studies, participants who took lisdexamfetamine used methamphetamine on fewer days over a 12-week period. Some evidence also suggests it might help with withdrawal symptoms from methamphetamine. However, the long-term effects remain unknown. In this trial, participants will receive either LDX-01, a form of lisdexamfetamine, or a placebo, alongside treatment as usual (TAU) for 25 weeks. Overall, lisdexamfetamine appears promising for those dealing with methamphetamine addiction. ^{2 3 5 6 7}

Who Is on the Research Team?

Didier Jutras-Aswad, MD

Principal Investigator

CHUM

Are You a Good Fit for This Trial?

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

Diagnosed with a moderate to severe MUD as defined by the DSM-5 criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive high-dose LDX-01 or placebo along with treatment-as-usual for 25 weeks

25 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

Visits at weeks 26 and 30 (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LDX-01

Trial Overview 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.

How Is the Trial Designed?

Group I: LDX-01 + TAU Experimental Treatment 1 Intervention

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

Group II: Placebo + TAU Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Health Canada

Collaborator

Trials

36

Recruited

38,700+

Ministere de la Sante et des Services Sociaux

Collaborator

Trials

19

Recruited

78,200+

Published Research Related to This Trial

A double-blind randomized controlled trial is underway to evaluate the efficacy of lisdexamfetamine (LDX) in reducing methamphetamine use among 180 participants with a history of dependence, aiming to assess both the effectiveness and safety of LDX over a 15-week treatment period.

The study will measure primary outcomes such as changes in self-reported methamphetamine use and confirmatory urinalyses, while also exploring secondary outcomes related to mental health, treatment retention, and cost-effectiveness, providing a comprehensive evaluation of LDX as a potential treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LiMA: a study protocol for a randomised, double-blind, placebo controlled trial of lisdexamfetamine for the treatment of methamphetamine dependence. Ezard, N., Dunlop, A., Hall, M., et al.[2019]

Lisdexamfetamine (LDX) at doses up to 250 mg/day was found to be safe and well tolerated among 16 adults with methamphetamine dependence, with 87.5% of participants completing the treatment regimen.

The study showed a significant reduction in methamphetamine use, with participants reporting a decrease from a median of 21 days of use to 13 days over the 4-week escalation period, indicating potential efficacy in treating methamphetamine dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study. Ezard, N., Clifford, B., Dunlop, A., et al.[2022]

This phase 2 study will assess the safety and tolerability of lisdexamfetamine at doses of 100 to 250 mg in 20 individuals with methamphetamine dependence over an 8-week period, aiming to establish its potential as a treatment option.

The study will also evaluate secondary outcomes such as changes in methamphetamine use, cravings, and withdrawal symptoms, which could provide insights into the drug's efficacy in reducing dependence and improving overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence. Ezard, N., Dunlop, A., Clifford, B., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39701142/

Lisdexamfetamine in the treatment of methamphetamine ... Lisdexamfetamine appears to reduce methamphetamine use over a 12-week treatment period, although there is only weak evidence that reduced use is maintained ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.16730

Lisdexamfetamine in the treatment of methamphetamine ... Lisdexamfetamine appears to reduce methamphetamine use over a 12-week treatment period, although there is only weak evidence that reduced use is ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S037687162200429X

Lisdexamfetamine for the treatment of acute ... A tapering dose regimen of lisdexamfetamine was safe and feasible for the treatment of acute methamphetamine withdrawal in an inpatient setting.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05854667

Study Details | NCT05854667 | Clinical Trial of High Dose ... 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 ...

5. recoveryanswers.org recoveryanswers.org/research-post/medication-typically-prescribed-adhd-may-benefit-methamphetamine-use-disorder/

Medication typically prescribed for ADHD may offer some ... The results from this clinical trial found that, over the course of the medication period, those taking lisdexamfetamine used methamphetamine less days compared ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8137170/

Safety and tolerability of oral lisdexamfetamine in adults ... To examine the safety of an agonist-type treatment, lisdexamfetamine (LDX), at 250 mg/day among adults with methamphetamine (MA) dependence.

7. drugsandalcohol.ie drugsandalcohol.ie/42474/

Lisdexamfetamine in the treatment of methamphetamine ... Serious adverse events occurred in four (5%) of participants who received lisdexamfetamine. CONCLUSIONS Lisdexamfetamine appears to reduce methamphetamine use ...