Methamphetamine DependencePhase 3NCT00950352
Citicoline Treatment of Methamphetamine Dependence
A Phase 3 study testing Citicoline in people with Methamphetamine Dependence, run by Perry Renshaw at 1 site in United States.
Trial summary
The purpose of the study is to determine if citicoline (a nutritional supplement) is effective in helping people reduce their dependence on methamphetamine. The investigators will use neuroimaging to look at the structure and chemical make up of the brain at the start of the study and after 8-9 weeks of treatment of… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Citicoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who use methamphetamine as their preferred drug of abuse.
- Subjects must be between the ages of 18 and 45 years.
- Subjects must have recent methamphetamine use (within 6 months of screening).
- Subjects must have an established residence and phone.
- Subjects must be able to give informed consent.
- Subjects must be between the ages of 18 and 45 years.
- Subjects must be able to give informed consent.
- To have an established residence and phone.
Who cannot join
- Significant current or past medical, neurological, or psychiatric co-morbidity including cardiovascular, renal, and endocrine disorder, as identified by medical history.
- Pregnant subjects - due to the unknown effects of MRI on a fetus. 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.
- Subjects who, in the investigator's judgment, pose a current serious homicidal or suicidal risk.
- Subjects who will not likely be able to comply with the study protocol.
- Subjects who have any contraindication to an MR scan.
- Hypersensitivity to any of the study drugs or excipients
Show all 17Show fewer
- Subjects with current DSM-IV diagnosis of a major mental illness. Major illness will be defined as Major Depression, Manic Depression, Schizophrenia, Dissociative Disorder, other psychotic illnesses, Attention-Deficit Hyperactivity Disorder, Post Traumatic Stress Disorder, Borderline Personality Disorder, Reactive Attachment Disorder, and Panic Disorder.
- Predominant alcohol or other substance dependence as preferred drug of abuse.
- Positive HIV test result.
- An individual having any pending legal or criminal charge or action, or who has pending or a reasonable potential for court involvement, or a person who is incarcerated or is in detention, or who is pending or having completed a competency evaluation or commitment procedure.
- Healthy Control Subject Eligibility:
- Significant medical, neurological, or psychiatric disorders
- Pregnant subjects - due to the unknown effects of MRI on a fetus. 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.
- Subjects who have any contraindication to an MR scan.
- Subjects unable to comply with protocol.
- Positive HIV test result.
- Positive urine drug screen.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Brain Institute of the University of Utah
Salt Lake City, Utah, 84108
About this study
The purpose of the study is to determine if citicoline (a nutritional supplement) is effective in helping people reduce their dependence on methamphetamine. The investigators will use neuroimaging to look at the structure and chemical make up of the brain at the start of the study and after 8-9 weeks of treatment of citicoline or placebo.
Read the detailed description
This is a prospective, randomized, double-blind, placebo-controlled study, in which we will systematically evaluate the therapeutic effects of citicoline, which may both increase dopamine and normalize cognitive and structural deficits in the brains of methamphetamine dependent subjects. Methamphetamine dependent subjects will undergo baseline and repeat cognitive assessments after 8-9 weeks of placebo or oral citicoline as a nutritional supplement. We will also evaluate the chemical and structural changes in brain regions identified by magnetic resonance spectroscopy (MRS), diffusion tension imaging (DTI) and cortical thickness, which in turn are expected to recover after 8-9 weeks of citicoline treatment. Specific brain regions of interest include the prefrontal cortices, temporal cortex, and the caudate/putamen all of which are known to be involved in the pathophysiology of methamphetamine dependence.
- Conditions
- Methamphetamine Dependence
- Being tested
- Citicoline, Placebo
- Keywords
- methamphetamine, Citicoline, CDP-Choline, Neuroimaging, MRI, Brain, MRS, DTI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiticolineDrug
Also called CDP-Choline
Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.
PlaceboDrug
Subjects will be given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
| Study group | Role | What they receive |
|---|---|---|
| Citicoline | Experimental | In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks. Receives: Drug: Citicoline |
| Placebo | Placebo comparator | In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo
Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.
Measured: 8 weeks, assessed twice weekly starting week1
Secondary outcomes (3)
Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance.
Cognitive measurement tests will be employed.
Measured: Neuropsychological testing will occur at week 0 and week 8/9
Testing if Neuroimaging Measures Will Show Significant Improvements in Brain Chemical and Structural Parameters After 8-9 Weeks of Citicoline Treatment in Methamphetamine Dependent Subjects.
Phosphorus-31 ((31)P) magnetic resonance spectroscopy (MRS) was used to evaluate changes in mitochondrial high energy phosphates, including phosphocreatine (PCr) and β-nucleoside triphosphate (β-NTP, primarily ATP in brain) levels.
Measured: Neuroimaging will occur at week 0 and week 8/9
Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use.
Self report drug use and mood will be evaluated at each study visit throughout the course of the study. Also, urine samples will be collected twice a week for drugs of abuse testing.
Measured: Throughout the course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Methamphetamine DependenceStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perry Renshaw
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Perry Renshaw, University of Utah
- Investigators
- Perry F Renshaw, MD, PhD, MBA, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950352
- Sponsor's protocol ID
- 32808
- Other IDs
- CDP-1212
- Status last verified
- Feb 2015
- First submitted
- 29 Jul 2009
- Last updated
- 11 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citicoline Treatment of Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00950352
- Acronym / sponsor ID
- 32808
- Conditions
- Methamphetamine Dependence
- Keywords
- methamphetamine, Citicoline, CDP-Choline, Neuroimaging, MRI, Brain, MRS, DTI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Perry RenshawUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Posted 11 Feb 2015
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 citicoline (a nutritional supplement) is effective in helping people reduce their dependence on methamphetamine. The investigators will use neuroimaging to look at the structure and chemical make up of the brain at the start of the study and after 8-9 weeks of treatment of citicoline or placebo.
Detailed description
This is a prospective, randomized, double-blind, placebo-controlled study, in which we will systematically evaluate the therapeutic effects of citicoline, which may both increase dopamine and normalize cognitive and structural deficits in the brains of methamphetamine dependent subjects. Methamphetamine dependent subjects will undergo baseline and repeat cognitive assessments after 8-9 weeks of placebo or oral citicoline as a nutritional supplement. We will also evaluate the chemical and structural changes in brain regions identified by magnetic resonance spectroscopy (MRS), diffusion tension imaging (DTI) and cortical thickness, which in turn are expected to recover after 8-9 weeks of citicoline treatment. Specific brain regions of interest include the prefrontal cortices, temporal cortex, and the caudate/putamen all of which are known to be involved in the pathophysiology of methamphetamine dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citicoline | Experimental | Drug: CiticolineIn a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboIn a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects who use methamphetamine as their preferred drug of abuse.
- Subjects must be between the ages of 18 and 45 years.
- Subjects must have recent methamphetamine use (within 6 months of screening).
- Subjects must have an established residence and phone.
- Subjects must be able to give informed consent.
Key exclusion criteria (17 listed)
- Significant current or past medical, neurological, or psychiatric co-morbidity including cardiovascular, renal, and endocrine disorder, as identified by medical history.
- Pregnant subjects - due to the unknown effects of MRI on a fetus. 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.
- Subjects who, in the investigator's judgment, pose a current serious homicidal or suicidal risk.
- Subjects who will not likely be able to comply with the study protocol.
- Subjects who have any contraindication to an MR scan.
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 |
|---|---|---|
| CiticolineAlso: CDP-CholineSubjects will be given 1g citicoline twice daily for a total of 8-9 weeks. | Drug | Citicoline |
| PlaceboSubjects will be given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group. | Drug | Placebo |
Primary outcome
Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo
Time frame: 8 weeks, assessed twice weekly starting week1
Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.
3 secondary outcomes
Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance.
Time frame: Neuropsychological testing will occur at week 0 and week 8/9
Testing if Neuroimaging Measures Will Show Significant Improvements in Brain Chemical and Structural Parameters After 8-9 Weeks of Citicoline Treatment in Methamphetamine Dependent Subjects.
Time frame: Neuroimaging will occur at week 0 and week 8/9
Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use.
Time frame: Throughout the course of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Brain InstituteLink provided by the sponsor.
- NIDALink provided by the sponsor.
- Assessment and Referral ServicesLink provided by the sponsor.
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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.
Perry F Renshaw, MD, PhD, MBA principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Citicoline in people with Methamphetamine Dependence, run by Perry Renshaw at 1 site in United States.
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 8 inclusion and 17 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 11 Feb 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo (time frame: 8 weeks, assessed twice weekly starting week1). 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 11 Feb 2015.