CDP-choline Treatment in ATS Users

NCT ID: NCT02630069

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2022-12-31

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.

Conditions

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Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CDP-choline+supportive psychotherapy

CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks

Group Type EXPERIMENTAL

CDP-choline

Intervention Type DRUG

CDP-choline 500mg once a day for 12 weeks

Supportive psychotherapy

Intervention Type BEHAVIORAL

Supportive psychotherapy 1 session/2 weeks for 12 weeks

Placebo+supportive psychotherapy

Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 500mg once a day for 12 weeks

Supportive psychotherapy

Intervention Type BEHAVIORAL

Supportive psychotherapy 1 session/2 weeks for 12 weeks

Healthy control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CDP-choline

CDP-choline 500mg once a day for 12 weeks

Intervention Type DRUG

Placebo

Placebo 500mg once a day for 12 weeks

Intervention Type DRUG

Supportive psychotherapy

Supportive psychotherapy 1 session/2 weeks for 12 weeks

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

14 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sujung Yoon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sujung Yoon, MD, PhD

Role: CONTACT

82-2-3277-2478

Facility Contacts

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Sung Hui Kim, BSN, RN

Role: primary

82-2-2650-2812

Other Identifiers

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NIH_ATS

Identifier Type: -

Identifier Source: org_study_id

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