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Add-on Low Dose Dextromethorphan and Memantine in Patients With Amphetamine-type Stimulants Use Disorder

NCT ID: NCT03729128

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-24

Study Completion Date

2020-08-31

Brief Summary

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The current study will investigate whether add-on dextromethorphan (DM) and memantine (MM) is able to improve the treatment outcomes for ATSUD, and be associated with improvement in inflammatory markers, neurotrophic factors and neuropsychological tests.

Detailed Description

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In current study, we will conduct a randomized double-blind placebo-controlled study. We will recruit 100-120 patients with ATSUD in three years and allocate them to add-on low dose dextromethorphan and memantine (DM 30mg/day+MM 5mg/day) or placebo group in a 1: 1 ratio (patients will also undergo usual psychosocial interventions). We 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. Neuropsychological assessments and tests for inflammatory parameters and neurotrophic factors will also be measured during 12-weeks follow up. The study results will show that whether add-on DM+MM is able to improve the treatment outcomes for ATSUD, and be associated with improvement in inflammatory markers, neurotrophic factors and neuropsychological tests.

Conditions

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Stimulants Use Disorder

Keywords

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amphetamine-type stimulants use disorder dextromethorphan memantine inflammation neurodegeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dextromethorphan and memantine (DM+MM)

The patients with Amphetamine-type stimulants use disorder will be recruited and received treatment of add-on dextromethorphan 30mg/day and memantine 5mg/day combination (DM+MM) for 12 weeks.

Group Type EXPERIMENTAL

dextromethorphan and memantine (DM+MM)

Intervention Type DRUG

Patients of Amphetamine-type stimulants use disorder (ATSUD) will take dextromethorphan 30 mg/day and memantine 5 mg/day combination (DM+MM) daily for 12 weeks.

Placebos

The patients with Amphetamine-type stimulants use disorder will be recruited and received treatment of add-on placebos for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Patients of Amphetamine-type stimulants use disorder (ATSUD) will take placebos daily for 12 weeks.

Interventions

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dextromethorphan and memantine (DM+MM)

Patients of Amphetamine-type stimulants use disorder (ATSUD) will take dextromethorphan 30 mg/day and memantine 5 mg/day combination (DM+MM) daily for 12 weeks.

Intervention Type DRUG

Placebos

Patients of Amphetamine-type stimulants use disorder (ATSUD) will take placebos daily for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

The presence of any of the following will exclude a patient from study enrollment:

1. 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.
2. Females who are pregnant or lactation.
3. Other major Axis-I DSM-IV diagnosis other than ATSUD, except for tobacco use disorder, ATS induced mood or psychotic disorders.
4. 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.
5. History of allergy or intolerable side effects of DM or MM.
6. Suicidal attempts or risks during screen or study period.
7. Presence of active infectious or autoimmune disease.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

Tzu-Yun Wang

OTHER

Sponsor Role lead

Responsible Party

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Tzu-Yun Wang

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tzu-Yun Wang

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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B-BR-106-094

Identifier Type: -

Identifier Source: org_study_id