CDP-choline Treatment in ATS Users

Sponsor
Ewha Womans University Mokdong Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02630069
Collaborator
(none)
160
1
3
93
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cytidine-5'-Diphosphate-choline Treatment in Amphetamine Type Stimulant-using Adolescents
Actual Study Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Drug: Placebo
Placebo 500mg once a day for 12 weeks

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

No Intervention: Healthy control

No intervention

Outcome Measures

Primary Outcome Measures

  1. the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening [baseline through 12 weeks]

  2. abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples [baseline through 12 weeks]

  3. treatment program retention [baseline through 12 weeks]

Secondary Outcome Measures

  1. standardized scores on a neuropsychological test battery [baseline and 12 weeks]

  2. number of participants with adverse events [baseline through 12 weeks]

  3. structural brain changes in magnetic resonance imaging assessed by computational approaches [baseline and 12 weeks]

  4. functional brain changes in magnetic resonance imaging assessed by computational approaches [baseline and 12 weeks]

  5. metabolic brain changes in magnetic resonance imaging assessed by computational approaches [baseline and 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ewha Womans University Mokdong Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Ewha Womans University Mokdong Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sujung Yoon, Professor, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier:
NCT02630069
Other Study ID Numbers:
  • NIH_ATS
First Posted:
Dec 15, 2015
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Keywords provided by Sujung Yoon, Professor, Ewha Womans University Mokdong Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022