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This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDP-choline+supportive psychotherapy | Experimental | CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks |
|
| Placebo+supportive psychotherapy | Placebo Comparator | Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks |
|
| Healthy control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDP-choline | Drug | CDP-choline 500mg once a day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening | baseline through 12 weeks | |
| abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples | baseline through 12 weeks | |
| treatment program retention | baseline through 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| standardized scores on a neuropsychological test battery | baseline and 12 weeks | |
| number of participants with adverse events | baseline through 12 weeks | |
| structural brain changes in magnetic resonance imaging assessed by computational approaches |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sujung Yoon, MD, PhD | Contact | 82-2-3277-2478 | sujungjyoon@ewha.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Mokdong Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| Placebo |
| Drug |
Placebo 500mg once a day for 12 weeks |
|
| Supportive psychotherapy | Behavioral | Supportive psychotherapy 1 session/2 weeks for 12 weeks |
|
| baseline and 12 weeks |
| functional brain changes in magnetic resonance imaging assessed by computational approaches | baseline and 12 weeks |
| metabolic brain changes in magnetic resonance imaging assessed by computational approaches | baseline and 12 weeks |
| D009930 |
| Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |