Clinical Trial of High Dose Lisdexamfetamine & Contingency Management in

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05854667
Study type	Interventional
Source	Centre hospitalier de l'Université de Montréal (CHUM)
Contact	Devon Blanchette
Phone	780-953-6630
Email	dblanchette@changemark.ca
Status	Recruiting
Phase	Phase 2
Start date	December 5, 2023
Completion date	November 2025

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03576768` - QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt	N/A
Completed	`NCT04110626` - Realistic Evaluation of Expériences Animées, a School-based Intervention in Nouvelle Aquitaine
Completed	`NCT03007940` - Using NIATx Strategies to Implement Integrated Services in Routine Care	N/A
Not yet recruiting	`NCT04030858` - The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery	N/A
Completed	`NCT03347643` - The Effectiveness of tDCS on Internet Game Addiction	Phase 2
Active, not recruiting	`NCT02836080` - Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)	N/A
Completed	`NCT03221985` - ESM Pilot: Mobile Phones and Psychology	N/A
Completed	`NCT02556060` - Lamotrigine for Ketamine Dependence Trial	Phase 2/Phase 3
Completed	`NCT01531153` - Cognitive Enhancement as a Target for Cocaine Pharmacotherapy	N/A
Completed	`NCT02812810` - Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence	N/A
Recruiting	`NCT05976646` - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion	Phase 1/Phase 2
Completed	`NCT04409106` - The Turkish Version of the Parental Smartphone Use Management Scale (PSUMS)
Recruiting	`NCT05595759` - Violence Against Women in Patients With Alcohol Substance Addiction Training	N/A
Completed	`NCT04099173` - A Brief Mindfulness-Based Intervention for Suicidal Ideation	N/A
Recruiting	`NCT04959643` - Systematic Screening for Viral Hepatitis B and C at the PASS Consultation of the Montpellier University Hospital
Completed	`NCT04133688` - Mobile App in Addiction	N/A
Recruiting	`NCT04063267` - Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder	Phase 2
Completed	`NCT05114577` - Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery	N/A
Terminated	`NCT02671240` - Prognosis of Behavioral Addiction in Parkinson's Disease
Not yet recruiting	`NCT03813095` - Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms