CDP-choline Treatment in ATS Users
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: CDP-choline+supportive psychotherapy CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks |
Drug: CDP-choline
CDP-choline 500mg once a day for 12 weeks
Behavioral: Supportive psychotherapy
Supportive psychotherapy 1 session/2 weeks for 12 weeks
|
Placebo Comparator: Placebo+supportive psychotherapy Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks |
Drug: Placebo
Placebo 500mg once a day for 12 weeks
Behavioral: Supportive psychotherapy
Supportive psychotherapy 1 session/2 weeks for 12 weeks
|
No Intervention: Healthy control No intervention |
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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 [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged 14-40 years
-
Amphetamine (or amphetamine-like) use disorder (DSM-IV-TR)
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Informed consent
-
Seeking treatment
Exclusion Criteria:
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Major medical or neurological illnesses
-
Psychiatric illnesses requiring hospitalization, prescription of psychotropic medications, or emergency psychiatric interventions
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Current and past diagnosis of a psychotic disorder, bipolar disorder, conduct disorder, or attention-deficit hyperactivity disorder
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Occasional ATS use (less than monthly use)
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IQ of 80 or lower
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Pregnancy or breastfeeding
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Clinically significant suicidal or homicidal ideation
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Substance use disorders (substances other than amphetamine or MA)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ewha Womans University Mokdong Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Ewha Womans University Mokdong Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIH_ATS