CDP-choline Treatment in ATS Users

Ewha Womans University Mokdong Hospital160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Substance Use Disorders

Interventions

CDP-cholineDRUG

CDP-choline 500mg once a day for 12 weeks

PlaceboDRUG

Placebo 500mg once a day for 12 weeks

Supportive psychotherapyBEHAVIORAL

Supportive psychotherapy 1 session/2 weeks for 12 weeks

Eligibility

Sex: ALLMin age: 14 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening

Time frame: baseline through 12 weeks

abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples

Time frame: baseline through 12 weeks

treatment program retention

Time frame: baseline through 12 weeks

Secondary Outcomes

standardized scores on a neuropsychological test battery

Time frame: baseline and 12 weeks

number of participants with adverse events

Time frame: baseline through 12 weeks

structural brain changes in magnetic resonance imaging assessed by computational approaches

Time frame: baseline and 12 weeks

functional brain changes in magnetic resonance imaging assessed by computational approaches

Time frame: baseline and 12 weeks

metabolic brain changes in magnetic resonance imaging assessed by computational approaches

Time frame: baseline and 12 weeks

Central Contacts

Sujung Yoon, MD, PhD

CONTACT

82-2-3277-2478 sujungjyoon@ewha.ac.kr

Data from ClinicalTrials.gov

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