CDP-choline Treatment in ATS Users

Phase 2

• Conditions: Substance Use Disorders
• Interventions: Drug: Placebo; Drug: CDP-choline; Behavioral: Supportive psychotherapy

• Registration Number: NCT02630069
• Lead Sponsor: Ewha Womans University Mokdong Hospital

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-12-06
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Aged 14-40 years
• Amphetamine (or amphetamine-like) use disorder (DSM-IV-TR)
• Informed consent
• Seeking treatment

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo+supportive psychotherapy	Placebo	Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
CDP-choline+supportive psychotherapy	Supportive psychotherapy	CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
Placebo+supportive psychotherapy	Supportive psychotherapy	Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
CDP-choline+supportive psychotherapy	CDP-choline	CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
standardized scores on a neuropsychological test battery	baseline and 12 weeks
structural brain changes in magnetic resonance imaging assessed by computational approaches	baseline and 12 weeks
number of participants with adverse events	baseline through 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

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of