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

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. Usual treatment and placebo
2. Usual treatment, placebo and contingency management
3. Usual treatment and high dose stimulant
4. Usual treatment, high dose stimulant and contingency management

Participation includes the following:

1. Participants will receive medication or placebo weekly for 15 weeks.
2. Participants will attend the clinic for weekly treatment
3. 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

Interventions

DRUG

Treatment as Usual plus Placebo

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

DRUG

Treatment as Usual plus Placebo plus Contingency Management

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.

DRUG

Treatment as Usual plus lisdexamfetamine (LDX-01)

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).

DRUG

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

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Centre hospitalier de l'Université de Montréal (CHUM)

  lead OTHER

Principal Investigators

• Didier Jutras-Aswad · University of Montreal Hospital Research Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-05

Primary Completion

2027-12-31

Completion

2028-04-30

Countries

• Canada

Study Locations