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

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

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.

What data supports the effectiveness of the drug LDX-01 for methamphetamine addiction?

Lisdexamfetamine (LDX) is being studied for methamphetamine addiction because it has been effective in treating other conditions like ADHD and binge eating disorder, and it has a lower risk of misuse due to its unique formulation. Similar types of treatments have been successful for other addictions, like opioids and nicotine. ^{1 2 3 4 5}

Is lisdexamfetamine safe for humans?

Lisdexamfetamine has been studied for safety in treating methamphetamine dependence and is already used for conditions like ADHD and binge eating disorder. It is generally considered safe, with a lower risk of misuse due to its formulation, but like any medication, it may have side effects. ^{1 2 3 6 7}

How is the drug Lisdexamfetamine unique for treating methamphetamine addiction?

Lisdexamfetamine is unique because it is a prodrug, meaning it is inactive until it is converted in the body to its active form, d-amphetamine, which reduces the risk of misuse. It is being studied as a potential treatment for methamphetamine addiction, a condition with no currently approved medications, and it has a longer-lasting effect with a lower potential for abuse compared to other stimulant treatments. ^{1 2 3 8 9}

Research Team

Didier Jutras-Aswad, MD

Principal Investigator

CHUM

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study. [2022]

2. England 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of therapy augmentation and deviation rates from the recommended once-daily dosing regimen between LDX and commonly prescribed long-acting stimulants for the treatment of ADHD in youth and adults. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term safety and effectiveness of lisdexamfetamine dimesylate in adults with attention-deficit/ hyperactivity disorder. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Lisdexamfetamine: A pharmacokinetic review. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and Pharmacodynamic Properties of Lisdexamfetamine in Adults with Attention-Deficit/Hyperactivity Disorder. [2018]

9. England pubmed.ncbi.nlm.nih.gov

The use of lisdexamfetamine dimesylate for the treatment of ADHD and other psychiatric disorders. [2015]