CDP-choline Treatment in ATS Users

July 28, 2022 updated by: Sujung Yoon, Ewha Womans University Mokdong Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University Mokdong Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening
Time Frame: baseline through 12 weeks
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
baseline through 12 weeks
treatment program retention
Time Frame: baseline through 12 weeks
baseline through 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
standardized scores on a neuropsychological test battery
Time Frame: baseline and 12 weeks
baseline and 12 weeks
number of participants with adverse events
Time Frame: baseline through 12 weeks
baseline through 12 weeks
structural brain changes in magnetic resonance imaging assessed by computational approaches
Time Frame: baseline and 12 weeks
baseline and 12 weeks
functional brain changes in magnetic resonance imaging assessed by computational approaches
Time Frame: baseline and 12 weeks
baseline and 12 weeks
metabolic brain changes in magnetic resonance imaging assessed by computational approaches
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 6, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIH_ATS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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