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

NCT04687566 | Unknown Phase 2

• 1 other identifier: MOST 109-2314-B-006-056
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amphetamine Addiction; Pharmacotherapy

Keywords

amphetamine-type stimulants use disorder, dextromethorphan, memantine, inflammation, neurodegeneration, functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Urinary amphetamine positive rates

  The urinary amphetamine tests will be examined during the 12 weeks of treatment period in patients with ATSUD and the results will be compared between the experimental and placebo groups.

  12 weeks

Secondary Outcomes (4)

• The Wisconsin Card Sorting Test (WCST)

  12 weeks

• The Continuous performance tests (CPT)

  12 weeks

• The Wechsler Memory Scale - third edition (WMS-III)

  12 weeks

• inflammatory markers

  12 weeks

Study Arms (4)

dextromethorphan

EXPERIMENTAL

Dextromethorphan, 60 mg per day, once daily, for 12 weeks

Drug: Dextromethorphan

memantine

EXPERIMENTAL

Memantine, 5 mg per day, once daily, for 12 weeks

Drug: Memantine

dextromethorphan and memantine

EXPERIMENTAL

Dextromethorphan (60mg per day) and memantine (5 mg per day) combination, once daily, for 12 weeks

Drug: Dextromethorphan and memantine

placebo

PLACEBO COMPARATOR

placebo, once daily, for 12 weeks

Drug: Placebo

Interventions

Dextromethorphan DRUG

The participants will take dextromethorphan 60 mg per day, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.

dextromethorphan

Memantine DRUG

The participants will take memantine 5 mg per day, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.

memantine

Dextromethorphan and memantine DRUG

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.

dextromethorphan and memantine

Placebo DRUG

The participants will take the placebo pills, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.

placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent by patient or legal representative.
• Male or female patient aged ≧20 and ≦65 years.
• A diagnosis of ATSUD according to DSM criteria made by a specialist in psychiatry.
• Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.

You may not qualify if:

• The presence of any of the following will exclude a patient from study enrollment:
• Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study.
• Females who are pregnant or lactation.
• Other major Axis-I DSM-IV diagnosis other than ATSUD, except for tobacco use disorder, ATS induced mood or psychotic disorders.
• Current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation.
• History of allergy or intolerable side effects of DM or MM.
• Suicidal attempts or risks during screen or study period.
• Presence of active infectious or autoimmune disease.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Tainan, 70428, Taiwan

RECRUITING

MeSH Terms

Conditions

Amphetamine-Related Disorders; Inflammation; Nerve Degeneration

Interventions

Dextromethorphan; Memantine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tzu-Yun Wang

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu-Yun Wang

CONTACT

+8862353535; tzuyun0105@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 29, 2020
• Study Start: August 11, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

TW (1)