Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT05854667
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. 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.
Detailed Description:
The ASCME trial is a multi-centre, randomized double blind (lisdexamfetamine-01 component), open label (Contingency Management component), dose-ascending, placebo controlled trial. Participants will be enrolled in one of the 4 treatment arms:
Arm 1: treatment as usual plus placebo Arm 2: treatment as usual plus placebo and contingency management Arm 3: treatment as usual plus lisdexamfetamine (LDX-01) Arm 4: treatment as usual plus lisdexamfetamine (LDX-01) and contingency management
The trial will enroll 440 participants, and will be conducted in 5-7 treatment centres across Canada.
Participants will be enrolled in the trial for 20 weeks altogether.
Study:
NCT05854667
Study Brief:
Protocol Section:
NCT05854667