Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users

NCT05854667 | Recruiting Phase 2 DMC

• 1 other identifier: 23.053
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 4

Brief Summary

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? Is a high dose stimulant with contingency management better than placebo and usual treatment at helping people reduce the number of days they use methamphetamine? Participants will be placed randomly into one of four groups:

1. 1.Usual treatment and placebo
2. 2.Usual treatment, placebo and contingency management
3. 3.Usual treatment and high dose stimulant
4. 4.Usual treatment, high dose stimulant and contingency management
5. 5.Participants will receive medication or placebo weekly for 15 weeks.
6. 6.Participants will attend the clinic for weekly treatment
7. 7.Participants will attend the clinic once every 2 weeks for study visits. Each visit will take about an hour to complete. At these visits, participants will be asked to provide a urine sample and complete questionnaires.

Conditions

Methamphetamine Abuse; Methamphetamine-dependence; Addiction, Substance; Addiction

Keywords

Contingency Management; Treatment as Usual

Outcome Measures

Primary Outcomes (1)

• Total number of days of methamphetamine use during maintenance phase

  The primary outcome measure is the total number of days of MA use during the 12-week maintenance treatment period of the trial, assessed via self-report using the Timeline Followback (TLFB) Questionnaire.

  12 weeks

Secondary Outcomes (7)

• Medication Adherence

  15 weeks

• Safety Events

  20 weeks

• Changes in Quality of Life

  Will be administered at Baseline, Week 8, 14 and 20.

• Methamphetamine and other Substance Use - self report

  15 weeks

• Methamphetamine and other Substance Use - urine drug screen

  15 weeks

Study Arms (4)

Treatment as Usual plus Placebo

PLACEBO COMPARATOR

Participants will receive treatment as usual at the clinic as well as once daily lisdexamfetamine matched Placebo orally for 15 weeks.

Drug: Treatment as Usual plus Placebo

Treatment as Usual plus Placebo plus Contingency Management

PLACEBO COMPARATOR

Participants will receive treatment as usual at the clinic, once daily lisdexamfetamine matched placebo medication orally for 15 weeks, as well as engagement-focused contingency management.

Drug: Treatment as Usual plus Placebo plus Contingency Management

Treatment as Usual plus lisdexamfetamine (LDX-01)

ACTIVE COMPARATOR

Participants will receive treatment as usual at the clinic as well as once daily over-encapsulated lisdexamfetamine (LDX-01) orally for 15 weeks.

Drug: Treatment as Usual plus lisdexamfetamine (LDX-01)

Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management

ACTIVE COMPARATOR

Participants will receive treatment as usual at the clinic, once daily over-encapsulated lisdexamfetamine (LDX-01) orally for 15 weeks, as well as engagement-focused contingency management.

Drug: Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management

Interventions

Treatment as Usual plus Placebo DRUG

Participants receive once daily Lisdexamfetamine matched placebo for 15 weeks, as well as treatment as usual at clinical site.

Also known as: Contingency Management

Treatment as Usual plus Placebo

Treatment as Usual plus Placebo plus Contingency Management DRUG

Participants receive once daily Lisdexamfetamine matched placebo for 15 weeks, as well as treatment as usual at clinical site, and engagement-focused contingency management for 12 weeks, week 2-13.

Treatment as Usual plus Placebo plus Contingency Management

Treatment as Usual plus lisdexamfetamine (LDX-01) DRUG

Participants receive once daily Lisdexamfetamine for 15 weeks, as well as treatment as usual at clinical site. Medication is provided in 3 phases: Week 1 (Induction Phase): 100 mg (Day 1 and 2), 150 mg (Day 3 and 4), 200 mg (Day 5, 6 and 7) Weeks 2-13 (Maintenance Phase): 250 mg per day (or the maximum tolerated for each individual) and then will continue on the same daily dose Weeks 14-15 (Taper Phase): 150 mg (Week 14) and 50 mg (Week 15).

Treatment as Usual plus lisdexamfetamine (LDX-01)

Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management DRUG

Participants receive once daily Lisdexamfetamine for 15 weeks, as well as treatment as usual at clinical site. Medication is provided in 3 phases: Week 1 (Induction Phase): 100 mg (Day 1 and 2), 150 mg (Day 3 and 4), 200 mg (Day 5, 6 and 7) Weeks 2-13 (Maintenance Phase): 250 mg per day (or the maximum tolerated for each individual) and then will continue on the same daily dose Weeks 14-15 (Taper Phase): 150 mg (Week 14) and 50 mg (Week 15). Engagement-focused contingency management will be provided for 12 weeks, Week 2-13.

Also known as: Contingency Management

Treatment as Usual plus lisdexamfetamine (LDX-01) plus Contingency Management

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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, 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 oophorectomy); or
• 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 randomized 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.

You may not qualify if:

• \. Symptomatic or advanced cardiovascular disease (e.g., advanced arteriosclerosis), moderate hypertension; current hyperthyroidism confirmed via blood test; known hypersensitivity or idiosyncrasy to the sympathomimetic amines or glaucoma or any disabling, severe, OR unstable medical condition that, in the opinion of the study physician, precludes safe participation or the ability to provide fully informed consent; 2. Any severe or unstable co-morbid substance use disorder that, in the opinion of the study physician, precludes safe participation in the study; 3. Participants with Opioid Use Disorder (OUD) who have been on Opioid Agonist Therapy (OAT) for \< 12 weeks, and not yet at stabilization dose, or at stabilization dose \< 4 weeks; 4. Current or history of any serious psychiatric disorder (e.g., bipolar disorder, pre-existing psychosis, schizophrenia) that, in the opinion of the study physician, precludes safe participation in the study; 5. History of a severe adverse event, hypersensitivity or known allergic reaction to LDX or other amphetamine drugs OR hypersensitivity to the sympathomimetic amines; 6. Pregnant, nursing, or planning to become pregnant during the study period; 7. Planned extended absence during study period (e.g., pending legal action, surgery, incarceration, inpatient residential program) in the opinion of the study physician that might prevent completion of the study; 8. Use of an investigational drug for stimulant use disorder during the 30 days prior to screening, confirmed via self-report OR pharmacy records; 9. Currently receiving contingency management for the treatment of stimulant use disorder in the 4 weeks prior to screening, confirmed via self-report OR site records; 10. Use of prescribed amphetamine-type medication OR medication for the treatment of stimulant use disorder (e.g., methylphenidate, modafinil, bupropion) in the 4 weeks prior to screening; 11. Current or anticipated need for treatment with any medication that may interact with LDX (e.g., proton pump inhibitors, monoamine oxidase inhibitors \[MAOIs\]) used currently or within the past 14 days AND that would preclude study participant at the discretion of the study physician

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Rapid Access Addiction Medicine Clinic, St. Paul's Hospital

Vancouver, British Columbia, Canada

RECRUITING

River Stone Recovery Centre

Fredericton, New Brunswick, E3B 1E3, Canada

SUSPENDED

Center for Addiction and Mental Health

Toronto, Ontario, M6J 1HN, Canada

RECRUITING

University of Montreal Hospital Research Center

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Interventions

Therapeutics; Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Didier Jutras-Aswad

  University of Montreal Hospital Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devon Blanchette

CONTACT

780-953-6630; dblanchette@changemark.ca

Amina Sow

CONTACT

438 860 2452; amina.sow.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All participants will receive identical capsules (i.e., smell, taste, and colour), reducing bias by blinding participants, providers, and research staff to the study drug. To maintain the blinding of the study medication, dose adjustments will be known by Qualified Investigators and the Pharmacy team according to the Induction Phase schedule and at the Investigator's discretion, without unblinding the study medication (i.e., LDX-01 versus placebo) except for some limited safety related reasons. Access to the randomization code will be strictly controlled by the Data Management Centre. Each participant's assignment will be kept so that an individual code may be broken without unblinding the randomization allocation of other participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of four arms: 1. Treatment as Usual with Placebo 2. Treatment as Usual with Placebo and Contingency Management 3. Treatment as Usual with Lisdexamfetamine (LDX-01) 4. Treatment as usual with Lisdexamfetamine (LDX-01) and Contingency Management

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 11, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)