Methamphetamine DependencePhase 3NCT01007539
Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence
A Phase 3 study testing CDP-choline in people with Methamphetamine Dependence, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The purpose of the study is to determine if cytidine 5'diphosphocholine (CDP-choline, a naturally occurring chemical in your body) has efficacy in reducing the methamphetamine craving of the subjects with methamphetamine dependence craving and helping them maintain the abstinence. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- CDP-choline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Nov 2009to Jan 2012
- Phase
- Phase 3
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 19-60 year-old male or female
- Methamphetamine dependence diagnosed by DSM-IV
- Total cumulative dose for methamphetamine during the last two years: over 10 gram (over 200 shots of 0,05 mgram intravenous methamphetamine injection)
- Methamphetamine use in recent 4 weeks
- Subscale score of drug use in ASI: >2
Who cannot join
- Significant current or past medical, neurological, or psychiatric co-morbidity including cardiovascular, renal, and endocrine disorder, as identified by medical history
- Lifetime axis I psychiatric disorders of bipolar disorder, schizophrenia, identified by SCID-IV
- Socially dysfunctional antisocial personality disorder
- Current alcohol or nicotine dependence identified by SCID-IV
- Taking psychotropic medication in recent two months
- Head trauma history with loss of consciousness or seizure
Show all 9Show fewer
- Intelligence quotient < 80
- Pregnant subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded. Female subjects who are of child-bearing potential will have to pass a urine pregnancy test before each visit.
- Any contraindication to an MR scan
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul St. Mary's Hospital
Seoul, 137-701
Seoul National University Hospital
Seoul
About this study
The purpose of the study is to determine if cytidine 5'diphosphocholine (CDP-choline, a naturally occurring chemical in your body) has efficacy in reducing the methamphetamine craving of the subjects with methamphetamine dependence craving and helping them maintain the abstinence. In addition, investigators will measure the brain N-acetyl aspartate (a biologic marker for neuronal viability) level of participants to determine if brain deficits induced by methamphetamine may recover by taking CDP-choline.
- Conditions
- Methamphetamine Dependence
- Being tested
- CDP-choline, Placebo (fructose)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDP-cholineDietary supplement
The subjects will be given 1g citicoline twice daily for a total of 8 weeks.
Placebo (fructose)Dietary supplement
The Subjects will be given 2 tablets of placebo twice daily for 8 weeks. They will be taking the same quantity as the CDP-choline group.
| Study group | Role | What they receive |
|---|---|---|
| CDP-choline | Experimental | Not described Receives: Dietary Supplement: CDP-choline |
| Placebo (fructose) | Placebo comparator | Not described Receives: Dietary Supplement: Placebo (fructose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary drug screening test
Measured: 0-8 week visits
Secondary outcomes (11)
Craving symptoms
Measured: 0-8 week visits
Depressive symptoms
Measured: 0-8 week visits
Anxiety symptoms
Measured: 0-8 week visits
Side effect check
Measured: 1-8 week visits
Neuropsychological test battery
Measured: 0, 8 week visits
Clinical Global Impression
Measured: 0-8 week visits
Alcohol and tobacco use
Measured: 0, 4, 8 week visits
Addiction severity index
Measured: 0, 8 week visits
Withdrawal symptoms
Measured: 0-8 week visits
Magnetic Resonance Scan
Measured: 0, 8 week visits
Self-reported drug diary
Measured: 0-8 week visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007539
- Sponsor's protocol ID
- KC09MISI0166
- Status last verified
- Aug 2012
- First submitted
- 3 Nov 2009
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT01007539
- Acronym / sponsor ID
- KC09MISI0166
- Conditions
- Methamphetamine Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Nov 2009 (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.
The purpose of the study is to determine if cytidine 5'diphosphocholine (CDP-choline, a naturally occurring chemical in your body) has efficacy in reducing the methamphetamine craving of the subjects with methamphetamine dependence craving and helping them maintain the abstinence. In addition, investigators will measure the brain N-acetyl aspartate (a biologic marker for neuronal viability) level of participants to determine if brain deficits induced by methamphetamine may recover by taking CDP-choline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDP-choline | Experimental | Dietary Supplement: CDP-choline |
| Placebo (fructose) | Placebo comparator | Dietary Supplement: Placebo (fructose) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 19-60 year-old male or female
- Methamphetamine dependence diagnosed by DSM-IV
- Total cumulative dose for methamphetamine during the last two years: over 10 gram (over 200 shots of 0,05 mgram intravenous methamphetamine injection)
- Methamphetamine use in recent 4 weeks
- Subscale score of drug use in ASI: >2
Key exclusion criteria (9 listed)
- Significant current or past medical, neurological, or psychiatric co-morbidity including cardiovascular, renal, and endocrine disorder, as identified by medical history
- Lifetime axis I psychiatric disorders of bipolar disorder, schizophrenia, identified by SCID-IV
- Socially dysfunctional antisocial personality disorder
- Current alcohol or nicotine dependence identified by SCID-IV
- Taking psychotropic medication in recent two months
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-cholineThe subjects will be given 1g citicoline twice daily for a total of 8 weeks. | Dietary supplement | CDP-choline |
| Placebo (fructose)The Subjects will be given 2 tablets of placebo twice daily for 8 weeks. They will be taking the same quantity as the CDP-choline group. | Dietary supplement | Placebo (fructose) |
Primary outcome
Urinary drug screening test
Time frame: 0-8 week visits
11 secondary outcomes
Craving symptoms
Time frame: 0-8 week visits
Depressive symptoms
Time frame: 0-8 week visits
Anxiety symptoms
Time frame: 0-8 week visits
Side effect check
Time frame: 1-8 week visits
Neuropsychological test battery
Time frame: 0, 8 week visits
Clinical Global Impression
Time frame: 0-8 week visits
Alcohol and tobacco use
Time frame: 0, 4, 8 week visits
Addiction severity index
Time frame: 0, 8 week visits
Withdrawal symptoms
Time frame: 0-8 week visits
Magnetic Resonance Scan
Time frame: 0, 8 week visits
Self-reported drug diary
Time frame: 0-8 week visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CDP-choline in people with Methamphetamine Dependence, run by Seoul National University Hospital at 2 sites 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary drug screening test (time frame: 0-8 week visits). 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 31 Aug 2012.