Back to resultsCDP-choline Treatment in ATS Users
Primary Purpose
Substance Use Disorders
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CDP-choline
Placebo
Supportive psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders focused on measuring amphetamine type stimulant, adolescents
Eligibility Criteria
Inclusion Criteria:
- Aged 14-40 years
- Amphetamine (or amphetamine-like) use disorder (DSM-IV-TR)
- Informed consent
- Seeking treatment
Exclusion Criteria:
- Major medical or neurological illnesses
- Psychiatric illnesses requiring hospitalization, prescription of psychotropic medications, or emergency psychiatric interventions
- Current and past diagnosis of a psychotic disorder, bipolar disorder, conduct disorder, or attention-deficit hyperactivity disorder
- Occasional ATS use (less than monthly use)
- IQ of 80 or lower
- Pregnancy or breastfeeding
- Clinically significant suicidal or homicidal ideation
- Substance use disorders (substances other than amphetamine or MA)
Sites / Locations
- Ewha Womans University Mokdong HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
CDP-choline+supportive psychotherapy
Placebo+supportive psychotherapy
Healthy control
Arm Description
CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
No intervention
Outcomes
Primary Outcome Measures
the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening
abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples
treatment program retention
Secondary Outcome Measures
standardized scores on a neuropsychological test battery
number of participants with adverse events
structural brain changes in magnetic resonance imaging assessed by computational approaches
functional brain changes in magnetic resonance imaging assessed by computational approaches
metabolic brain changes in magnetic resonance imaging assessed by computational approaches
Full Information
NCT ID
NCT02630069
First Posted
December 6, 2015
Last Updated
July 28, 2022
Sponsor
Ewha Womans University Mokdong Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02630069
Brief Title
CDP-choline Treatment in ATS Users
Official Title
Cytidine-5'-Diphosphate-choline Treatment in Amphetamine Type Stimulant-using Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University Mokdong Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.
Detailed Description
This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline (CDP-choline) in amphetamine-type stimulants-using adolescents. Multi-level assessments will be performed to determine whether CDP-choline administration with supportive psychotherapy, compared to placebo administration with supportive psychotherapy, will 1) repair ATS-induced neural cell damage of the target brain regions, 2) improve cognitive deficits and normalize the relevant target neural circuits, and then 3) reduce ATS-taking behaviors in ATS-using adolescents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
amphetamine type stimulant, adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CDP-choline+supportive psychotherapy
Arm Type
Experimental
Arm Description
CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
Arm Title
Placebo+supportive psychotherapy
Arm Type
Placebo Comparator
Arm Description
Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
Arm Title
Healthy control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
CDP-choline
Intervention Description
CDP-choline 500mg once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 500mg once a day for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Supportive psychotherapy
Intervention Description
Supportive psychotherapy 1 session/2 weeks for 12 weeks
Primary Outcome Measure Information:
Title
the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening
Time Frame
baseline through 12 weeks
Title
abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples
Time Frame
baseline through 12 weeks
Title
treatment program retention
Time Frame
baseline through 12 weeks
Secondary Outcome Measure Information:
Title
standardized scores on a neuropsychological test battery
Time Frame
baseline and 12 weeks
Title
number of participants with adverse events
Time Frame
baseline through 12 weeks
Title
structural brain changes in magnetic resonance imaging assessed by computational approaches
Time Frame
baseline and 12 weeks
Title
functional brain changes in magnetic resonance imaging assessed by computational approaches
Time Frame
baseline and 12 weeks
Title
metabolic brain changes in magnetic resonance imaging assessed by computational approaches
Time Frame
baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 14-40 years
Amphetamine (or amphetamine-like) use disorder (DSM-IV-TR)
Informed consent
Seeking treatment
Exclusion Criteria:
Major medical or neurological illnesses
Psychiatric illnesses requiring hospitalization, prescription of psychotropic medications, or emergency psychiatric interventions
Current and past diagnosis of a psychotic disorder, bipolar disorder, conduct disorder, or attention-deficit hyperactivity disorder
Occasional ATS use (less than monthly use)
IQ of 80 or lower
Pregnancy or breastfeeding
Clinically significant suicidal or homicidal ideation
Substance use disorders (substances other than amphetamine or MA)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sujung Yoon, MD, PhD
Phone
82-2-3277-2478
Email
sujungjyoon@ewha.ac.kr
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Hui Kim, BSN, RN
Phone
82-2-2650-2812
Email
ewhactc@nate.com
12. IPD Sharing Statement
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CDP-choline Treatment in ATS Users
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