NCT02630069

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

7.8 years

First QC Date

December 6, 2015

Last Update Submit

July 28, 2022

Conditions

Substance Use Disorders

Keywords

amphetamine type stimulantadolescents

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • standardized scores on a neuropsychological test battery

    baseline and 12 weeks

  • number of participants with adverse events

    baseline through 12 weeks

  • structural brain changes in magnetic resonance imaging assessed by computational approaches

    baseline and 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

Study Arms (3)

CDP-choline+supportive psychotherapy

EXPERIMENTAL

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

Drug: CDP-cholineBehavioral: Supportive psychotherapy

Placebo+supportive psychotherapy

PLACEBO COMPARATOR

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

Drug: PlaceboBehavioral: Supportive psychotherapy

Healthy control

NO INTERVENTION

No intervention

Interventions

CDP-cholineDRUG

CDP-choline 500mg once a day for 12 weeks

CDP-choline+supportive psychotherapy
PlaceboDRUG

Placebo 500mg once a day for 12 weeks

Placebo+supportive psychotherapy
Supportive psychotherapyBEHAVIORAL

Supportive psychotherapy 1 session/2 weeks for 12 weeks

CDP-choline+supportive psychotherapyPlacebo+supportive psychotherapy

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsCytidine DiphosphateCytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Central Study Contacts

Sujung Yoon, MD, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 6, 2015

First Posted

December 15, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations

KR(1)