CDP-choline Treatment in ATS Users

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cytidine-5'-Diphosphate-choline Treatment in Amphetamine Type Stimulant-using Adolescents

Conditions
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Substance Use Disorders

Intervention / Treatment
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* Drug: CDP-choline
* Drug: Placebo
* Behavioral: Supportive psychotherapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDP-choline+supportive psychotherapy<br>CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks | Drug: CDP-choline<br>* CDP-choline 500mg once a day for 12 weeks<br>Behavioral: Supportive psychotherapy<br>* Supportive psychotherapy 1 session/2 weeks for 12 weeks<br>|
| Placebo Comparator: Placebo+supportive psychotherapy<br>Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks | Drug: Placebo<br>* Placebo 500mg once a day for 12 weeks<br>Behavioral: Supportive psychotherapy<br>* Supportive psychotherapy 1 session/2 weeks for 12 weeks<br>|
| No Intervention: Healthy control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amphetamine type stimulant, adolescents