Substance Use DisordersPhase 2NCT02630069
CDP-choline Treatment in ATS Users
A Phase 2 study testing CDP-choline and Supportive psychotherapy in people with Substance Use Disorders, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial summary
This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents. Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- CDP-choline and Supportive psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 14-40 years
- Amphetamine (or amphetamine-like) use disorder (DSM-IV-TR)
- Informed consent
- Seeking treatment
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ewha Womans University Mokdong Hospital
Seoul
Sung Hui Kim, BSN, RN, 82-2-2650-2812, ewhactc@nate.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- CDP-choline, Placebo, Supportive psychotherapy
- Keywords
- amphetamine type stimulant, adolescents
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDP-cholineDrug
CDP-choline 500mg once a day for 12 weeks
PlaceboDrug
Placebo 500mg once a day for 12 weeks
Supportive psychotherapyBehavioural
Supportive psychotherapy 1 session/2 weeks for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| CDP-choline+supportive psychotherapy | Experimental | CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks Receives: Drug: CDP-choline; Behavioral: Supportive psychotherapy |
| Placebo+supportive psychotherapy | Placebo comparator | Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks Receives: Drug: Placebo; Behavioral: Supportive psychotherapy |
| Healthy control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening
Measured: baseline through 12 weeks
abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples
Measured: baseline through 12 weeks
treatment program retention
Measured: baseline through 12 weeks
Secondary outcomes (5)
standardized scores on a neuropsychological test battery
Measured: baseline and 12 weeks
number of participants with adverse events
Measured: baseline through 12 weeks
structural brain changes in magnetic resonance imaging assessed by computational approaches
Measured: baseline and 12 weeks
functional brain changes in magnetic resonance imaging assessed by computational approaches
Measured: baseline and 12 weeks
metabolic brain changes in magnetic resonance imaging assessed by computational approaches
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sujung Yoon, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630069
- Sponsor's protocol ID
- NIH_ATS
- Status last verified
- Jul 2022
- First submitted
- 6 Dec 2015
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytidine-5'-Diphosphate-choline Treatment in Amphetamine Type Stimulant-using Adolescents
- ClinicalTrials.gov ID
- NCT02630069
- Acronym / sponsor ID
- NIH_ATS
- Conditions
- Substance Use Disorders
- Keywords
- amphetamine type stimulant, adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CDP-choline+supportive psychotherapy | Experimental | Drug: CDP-choline, Behavioral: Supportive psychotherapyCDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks |
| Placebo+supportive psychotherapy | Placebo comparator | Drug: Placebo, Behavioral: Supportive psychotherapyPlacebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks |
| Healthy control | No intervention | –No intervention |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 14-40 years
- Amphetamine (or amphetamine-like) use disorder (DSM-IV-TR)
- Informed consent
- Seeking treatment
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDP-cholineCDP-choline 500mg once a day for 12 weeks | Drug | CDP-choline+supportive psychotherapy |
| PlaceboPlacebo 500mg once a day for 12 weeks | Drug | Placebo+supportive psychotherapy |
| Supportive psychotherapySupportive psychotherapy 1 session/2 weeks for 12 weeks | Behavioural | CDP-choline+supportive psychotherapy, Placebo+supportive psychotherapy |
Primary outcome
the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening
Time frame: 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
treatment program retention
Time frame: baseline through 12 weeks
5 secondary outcomes
standardized scores on a neuropsychological test battery
Time frame: baseline and 12 weeks
number of participants with adverse events
Time frame: baseline through 12 weeks
structural brain changes in magnetic resonance imaging assessed by computational approaches
Time frame: baseline and 12 weeks
functional brain changes in magnetic resonance imaging assessed by computational approaches
Time frame: baseline and 12 weeks
metabolic brain changes in magnetic resonance imaging assessed by computational approaches
Time frame: baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDP-choline and Supportive psychotherapy in people with Substance Use Disorders, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujung Yoon, MD, PhD (82-2-3277-2478, sujungjyoon@ewha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening (time frame: baseline through 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.