CDP-choline Treatment in ATS Users

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02630069
• Other study ID #: NIH_ATS
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Ewha Womans University Mokdong Hospital
• Contact: Sujung Yoon, MD, PhD
• Phone: 82-2-3277-2478
• Email: sujungjyoon[@]ewha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• CDP-choline
CDP-choline 500mg once a day for 12 weeks
• Placebo
Placebo 500mg once a day for 12 weeks

Behavioral:
• Supportive psychotherapy
Supportive psychotherapy 1 session/2 weeks for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening		baseline through 12 weeks
Primary	abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples		baseline through 12 weeks
Primary	treatment program retention		baseline through 12 weeks
Secondary	standardized scores on a neuropsychological test battery		baseline and 12 weeks
Secondary	number of participants with adverse events		baseline through 12 weeks
Secondary	structural brain changes in magnetic resonance imaging assessed by computational approaches		baseline and 12 weeks
Secondary	functional brain changes in magnetic resonance imaging assessed by computational approaches		baseline and 12 weeks
Secondary	metabolic brain changes in magnetic resonance imaging assessed by computational approaches		baseline and 12 weeks