NCT04687566

Dextromethorphan, Memantine Monotherapy, or Combined Use of Dextromethorphan and Memantine in Amphetamine Addiction

Treatment Efficacy in Dextromethorphan, Memantine Monotherapy, or Combined Use of Dextromethorphan and Memantine in Patients With Amphetamine-type Stimulants Use Disorder

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The investigators will conducted a randomized double-blind placebo-controlled study to investigate the treatment outcomes of add-on low dose dextromethorphan (DM), memantine (MM), or dextromethorphan and memantine combination (DM+MM) in amphetamine-type stimulants use disorder patients.

Detailed description

The investigators will conducted a randomized double-blind placebo-controlled study to investigate the treatment outcomes of add-on low dose dextromethorphan (60mg/day, DM), memantine (5 mg/day, MM), or dextromethorphan (60mg/day) and memantine (5mg/day) combination (DM+MM) in amphetamine-type stimulants use disorder patients. The investigators will recruit 120 patients with ATSUD in three years and allocate participants to add-on DM, MM, DM+MM or placebo group in a 1:1:1:1 ratio (participants will also undergo usual psychosocial interventions).The investigators will follow up the participants for 12 weeks and measure the treatment responses, urine drug tests, craving scales and side effects to evaluate the therapeutic effects of add-on DM, MM, or DM+MM. Neuropsychological assessments, tests for inflammatory parameters and neurotrophic factors, and brain functional magnetic resonance imaging (fMRI) will also be evaluated during 12-weeks follow up.

Conditions

• Amphetamine Addiction
• Pharmacotherapy

Interventions

Type	Name	Description
DRUG	Dextromethorphan	The participants will take dextromethorphan 60 mg per day, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.
DRUG	Memantine	The participants will take memantine 5 mg per day, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.
DRUG	Dextromethorphan and memantine	The participants will take dextromethorphan (60 mg per day) and memantine (5 mg per day) combination, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.
DRUG	Placebo	The participants will take the placebo pills, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.

Timeline

• Start date: 2020-08-11
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2020-12-29
• Last updated: 2020-12-29

Locations

1 site across 1 country: Taiwan