Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03729128
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : March 2, 2020
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Tzu-Yun Wang, National Cheng-Kung University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stimulants Use Disorder Drug: dextromethorphan and memantine (DM+MM) Drug: Placebos Phase 1 Phase 2

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Potential Therapeutic Effects of add-on Low Dose Dextromethorphan and Memantine in Patients With Amphetamine-type Stimulants Use Disorder
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Placebo Comparator: Placebos
The patients with Amphetamine-type stimulants use disorder will be recruited and received treatment of add-on placebos for 12 weeks.
Drug: Placebos
Patients of Amphetamine-type stimulants use disorder (ATSUD) will take placebos daily for 12 weeks.




Primary Outcome Measures :
  1. Urinary amphetamine tests [ Time Frame: 12 weeks ]
    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.

  2. Craving severity [ Time Frame: 12 weeks ]
    The Visual analog scale (VAS) will be measured during the 12 weeks of treatment period in patients with ATSUD. The results will be compared between the experimental and placebo groups. The level of conscious craving was rated from 0 (none) to 100 (very much). Higher scores indicate more severe craving.

  3. Side effects checklists [ Time Frame: 12 weeks ]
    The investigators will use the self-reported questionnaire, side effects checklists, to evaluate the side effects during the 12 weeks of treatment period in patients with ATSUD. The side effects assessment includes, A) Mental Status/6-item, B) Genito-Urinary/4-item, C) Cardiovascular/4-item, D) Head-Neck/10-item, E) Extremities/9-item, F) Skin/4-item, and G) Gastrointestinal Tract/2-item. The severity of side effects were divided into 4 degrees as follows: 0 = Not present; 1 = Mild or occasional; 2 = Moderate or occurs several times a day; and 3 = Severe or persistent. Scores in each subscale will be summated to get the final total scores. Higher scores indicate more severe side effects. The results of side effects checklists will be compared between the experimental and placebo group.


Secondary Outcome Measures :
  1. Wisconsin Card Sorting Test (WCST) [ Time Frame: 12 weeks ]
    The Wisconsin Card Sorting Test (WCST) will be measured in patients with ATSUD at the initial screen period and at the endpoint (after 12 weeks of treatment). We will compare the changes from screen period to the endpoint between experimental and placebo group. Performance on the WCST was scored in terms of the total number of errors (TNE, range form 0-128), perseverative errors (PE, range from 0-118), conceptual level responses (CLRs, range from 0-100%), number of categories completed (NCC, range form 0-12), and trials to complete the first category (TCC, range from 0-128). Higher scores indicate worse performance in TNE, PE, and TCC. Higher scores indicate better performance in CLRs and NCC.

  2. Continuous performance tests (CPT) [ Time Frame: 12 weeks ]
    The Continuous performance tests (CPT) will be measured in patients with ATSUD at the initial screen period and at the endpoint (after 12 weeks of treatment). We will compare the changes from screen period to the endpoint between experimental and placebo group. The CPT produces a standard set of performance measures that include the number of errors of omission and errors of commission. (1) Errors of omission occur when the participant fails to respond to the target stimulus. The omission errors t-scores are ranged from 20-80 (0-100%). Higher scores indicated worse performance. (2) Errors of commission occur when the participant responds to a non-target (X) stimulus. The commission errors t-scores are ranged from 20-80 (0-100%). Higher scores indicated worse performance.

  3. Wechsler Memory Scale - third edition (WMS-III) [ Time Frame: 12 weeks ]
    The Wechsler Memory Scale - third edition (WMS-III) will be measured in patients with ATSUD at the initial screen period and at the endpoint (after 12 weeks of treatment). We will compare the changes from screen period to the endpoint between experimental and placebo group. WMS-III composite scores were calculated for the eight standardized primary indices: Auditory Immediate (AIM, range from 50-156), Visual Immediate (VIM, range from 47-162 ), Immediate Memory (IM, range from 40-164 ), Auditory Delayed (ADM, range from 46-162), Visual Delayed (VDM, range from 43-156), Auditory Recognition Delayed (ARDM, range from 55-145), General Memory (GM, range from 40-168), and Working Memory (WM, range from 45-156 ). Higher scores indicate better performance.

  4. Cytokines and neurotrophic factors [ Time Frame: 12 weeks ]
    The plasma levels of cytokines and neurotrophic factors, tumor necrosis factor α (TNF-α[pg/mL]), transforming growth factor β1 (TGF-β1 [pg/mL]), interleukin 6( IL-6[pg/mL]), interleukin 8(IL-8[pg/mL]), interleukin 1β (IL-1β[pg/mL]), and brain-derived neurotrophic factor(BDNF[pg/mL]), will be measured in patients with ATSUD at the initial screen period, day 1(baseline), week 4, 8, and 12(endpoint). We will compare the changes from screen period to the endpoint between the experimental and placebo group.

  5. C-reactive protein [ Time Frame: 12 weeks ]
    The plasma levels of C-reactive protein (CRP[μg/mL]) will be measured in patients with ATSUD at the initial screen period, day 1(baseline), week 4, 8, and 12(endpoint). We will compare the changes from screen period to the endpoint between the experimental and placebo group.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of these inclusion criteria to be eligible for enrollment into the study:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729128


Contacts
Layout table for location contacts
Contact: Tzu-Yun Wang 062353535 ext 4200 tzuyun0105@hotmail.com

Locations
Layout table for location information
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Tzu-Yun Wang    +886-6-235-3535 ext 4200    tzuyun0105@hotmail.com   
Principal Investigator: Tzu-Yun Wang         
Sponsors and Collaborators
Tzu-Yun Wang
Ministry of Science and Technology, Taiwan
Investigators
Layout table for investigator information
Principal Investigator: Tzu-Yun Wang National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Layout table for additonal information
Responsible Party: Tzu-Yun Wang, Principal Investigator, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT03729128    
Other Study ID Numbers: B-BR-106-094
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tzu-Yun Wang, National Cheng-Kung University Hospital:
amphetamine-type stimulants use disorder
dextromethorphan
memantine
inflammation
neurodegeneration
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Pathologic Processes
Memantine
Dextromethorphan
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antitussive Agents
Respiratory System Agents