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CDP-choline Treatment in ATS Users

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ClinicalTrials.gov Identifier: NCT02630069
Recruitment Status : Recruiting
First Posted : December 15, 2015
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Sujung Yoon, Ewha Womans University Mokdong Hospital

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
Substance Use Disorders Drug: CDP-choline Drug: Placebo Behavioral: Supportive psychotherapy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening [ Time Frame: baseline through 12 weeks ]
  2. abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples [ Time Frame: baseline through 12 weeks ]
  3. treatment program retention [ Time Frame: baseline through 12 weeks ]

Secondary Outcome Measures :
  1. standardized scores on a neuropsychological test battery [ Time Frame: baseline and 12 weeks ]
  2. number of participants with adverse events [ Time Frame: baseline through 12 weeks ]
  3. structural brain changes in magnetic resonance imaging assessed by computational approaches [ Time Frame: baseline and 12 weeks ]
  4. functional brain changes in magnetic resonance imaging assessed by computational approaches [ Time Frame: baseline and 12 weeks ]
  5. metabolic brain changes in magnetic resonance imaging assessed by computational approaches [ Time Frame: baseline and 12 weeks ]


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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630069


Contacts
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Contact: Sujung Yoon, MD, PhD 82-2-3277-2478 sujungjyoon@ewha.ac.kr

Locations
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Korea, Republic of
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sung Hui Kim, BSN, RN    82-2-2650-2812    ewhactc@nate.com   
Sponsors and Collaborators
Ewha Womans University Mokdong Hospital

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Responsible Party: Sujung Yoon, Professor, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier: NCT02630069     History of Changes
Other Study ID Numbers: NIH_ATS
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Keywords provided by Sujung Yoon, Ewha Womans University Mokdong Hospital:
amphetamine type stimulant
adolescents

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Choline
Cytidine Diphosphate Choline
Amphetamine
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors