Cocaine DependencePhase 2STED-CDNCT01715051
D-Serine for Cocaine Dependence Pilot
A Phase 2 study testing D-serine and Cognitive Behavioral Therapy in people with Cocaine Dependence, run by Theresa Winhusen at 1 site in United States.
Trial summary
The primary objective of this study is to collect pilot data on the efficacy of D-serine, relative to placebo, as a cocaine dependence treatment. Secondary objectives include evaluating D-serine, relative to placebo, on: 1. safety in treating cocaine-dependent adults and 2. tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- D-serine and Cognitive Behavioral Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be 18 years of age or older
- be able to understand the study, and having understood, provide written informed consent in English
- meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) dependence for cocaine,
- have at least 1 positive urine BE specimen (> 300 ng/mL) during screening/baseline with a minimum of 3 urine samples tested if screening/baseline is completed within 7 days or a minimum of 4 urine samples tested if screening/baseline is completed during a period >7 days and ≤ 14 days
- have a willingness to comply with all study procedures and medication instructions
- be seeking treatment for cocaine dependence
Show all 16Show fewer
- weigh >101 and <340 pounds
- if female and of child bearing potential, agree to use one of the following methods of birth control:
- oral contraceptives
- contraceptive patch
- barrier (diaphragm or condom)
- intrauterine contraceptive system
- levonorgestrel implant
- medroxyprogesterone acetate contraceptive injection
- complete abstinence from sexual intercourse
- hormonal vaginal contraceptive ring
Who cannot join
- have current dependence, defined by DSM-IV-TR criteria, on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
- have been enrolled in a medication assisted treatment program for opioid dependence (e.g., methadone, buprenorphine) within 2 months of consent.
- have a medical or psychiatric condition that, in the judgment of the study physician, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to:
- significant renal disease or estimated Glomerular Filtration Rate (GFR) ≤ 60
- AIDS according to the current Centers for Disease Control (CDC) criteria for AIDS
- liver function tests greater than 3 times the upper limit of normal
Show all 18Show fewer
- serum creatinine outside the normal range
- have initiated or had a dose change in psychotropic medication in the 28 days prior to randomization if currently taking psychotropic medication
- have a known or suspected hypersensitivity to D-serine
- be pregnant or breastfeeding or plan to become pregnant
- plan to take any of the following agents during the treatment phase:
- nonsteroidal anti-inflammatory drugs (NSAIDs)
- angiotensin-converting enzyme (ACE) inhibitors
- aminoglycosides
- angiotensin receptor blockers (ARBs)
- calcineurin inhibitors
- be anyone who, in the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.)
- be a significant suicidal/homicidal risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of D-Serine for Cocaine Dependence
The primary objective of this study is to collect pilot data on the efficacy of D-serine, relative to placebo, as a cocaine dependence treatment. Secondary objectives include evaluating D-serine, relative to placebo, on: 1. safety in treating cocaine-dependent adults and 2. tolerability.
Read the detailed description
STUDY DESIGN. This is a 12 week, 2 group randomized controlled trial that will be completed in an outpatient setting. Eligible participants will be randomized to D-serine or matching placebo and will be scheduled to attend three research visits per week throughout the active treatment phase which begins with randomization and ends on day 7 of study week 12. A single visit will be scheduled in week 13 to complete retrospective data for week 12. Participants will receive D-serine or placebo throughout the 12-week active treatment phase. Randomization will be in a 1:1 ratio, stratified by cocaine use frequency (<10 days or ≥ 10 days in the 28 days prior to consent).
STUDY POPULATION. Approximately 80 participants recruited from a single site will be randomized. The study population will include adults who meet Diagnostic and Statistical Manual-IV-Text Revision (DSM-IV-TR) criteria for cocaine dependence who have used cocaine in the 30 days prior to consent and who provide at least one benzoylecgonine (BE) positive urine during screening/baseline.
TREATMENTS. Study participants will be randomly assigned to receive either D-serine (target ~60 mg/kg per day) or matching placebo. All participants will receive once weekly manual-guided cognitive behavioral therapy during the 12 week treatment period. Medication adherence will be assessed with the Medication Events Monitoring System (MEMS).
EFFICACY ASSESSMENTS. The primary outcome measure will be cocaine abstinence for three or more consecutive weeks, with abstinence during a week defined as self-report of no cocaine use during the week as well as negative urine BE (BE<300 ng/mL) results during the week with at least two urine samples provided. Key secondary efficacy measures include the proportion of urine BE negative results obtained and cocaine abstinence during study weeks 11 and 12 as measured by self-report and urine BE. Other efficacy measures include drug attention bias, cocaine craving, drug compulsivity, cocaine withdrawal symptoms, and treatment retention.
SAFETY ASSESSMENTS. Safety measures include urinalysis, adverse events (AEs), vitals, electrocardiogram (ECG), and laboratory tests. Tolerability will be assessed by the proportion of participants needing a dose reduction and being discontinued from study medication.
ANALYSIS. Each outcome variable will be analyzed using appropriate statistical methods for the intention-to-treat (ITT) population and the evaluable population. All participants who have taken at least one study medication dose will be included in the safety analysis. Data will be summarized by treatment group. Summary statistics will include the mean, sample size, standard deviation, median, minimum and maximum values for continuous variables, and frequencies and percentages for categorical variables.
- Conditions
- Cocaine Dependence
- Being tested
- D-serine, Cognitive Behavioral Therapy, Placebo
- Keywords
- cocaine, D-serine, Drug dependence
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-serineDrug
The molecular formula for D-serine is C3H7NO3. D-serine is being used in IND# 71,369 (D Javitt, PI) and in IND#76,940 (H Singer, PI). This approved D-serine will be purchased by the Research Pharmacy at Johns Hopkins and will be encapsulated into capsules containing 500 mg of D-serine.
Cognitive Behavioral TherapyBehavioural
CBT sessions will be offered weekly to both active medication and placebo arms. The National Institute on Drug Abuse (NIDA) published CBT treatment manual for cocaine dependence, written by Kathleen Carroll, Ph.D., will be utilized. The skills taught in this CBT manual include (1) self-monitoring and functional analysis of situational factors associated with craving or drug use; (2) learning alternative non-drug responses for handling high risk situations; and (3) general lifestyle modifications (e.g., increasing pleasant drug-free events, anger management, interpersonal skills, general problem-solving).
PlaceboDrug
Also called Sugar Pill
The Research Pharmacy at Johns Hopkins will produce matching placebo capsules.
| Study group | Role | What they receive |
|---|---|---|
| D-serine | Active comparator | Participants randomized to D-serine will receive 500 mg tablets of D-serine based on the participant's weight in addition to weekly cognitive behavioral therapy (CBT). The number of capsules prescribed will be based on the target ~60 mg/kg per day dose. In practice, the mg/kg daily dose will range between approximately 55 mg/kg and 65 mg/kg. Dosing will be bid. Receives: Drug: D-serine; Behavioral: Cognitive Behavioral Therapy |
| Placebo | Placebo comparator | The number of placebo capsules prescribed to a study participant per day will be based on the participant's weight and will be bid dosing to match the dosing of D-serine. Receives: Behavioral: Cognitive Behavioral Therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with cocaine abstinence for three or more consecutive weeks as assessed by self-report and urine BE
The Timeline Follow-back (TLFB) procedure will be used to assess the participants' self-reported use of substances for each day of the study. Urine samples will be collected at each study visit using temperature monitoring and the validity of urine samples will be checked with the use of a commercially available adulterant test. The urine samples will be sent to a laboratory for analysis.
The self-report and urine BE results will be combined to score each participant as cocaine abstinent or non-abstinent for each study week.
Measured: Week 13 visit
Secondary outcomes (5)
Proportion of cocaine-negative Urine Drug Screens (UDS) during the treatment phase
The proportion of cocaine-negative UDS results is calculated by the number of results negative for cocaine (BE<300 ng/mL) divided by the total number of UDS results obtained for the participant during the 12 week treatment phase.
Measured: Week 13 visit
Proportion of participants achieving cocaine abstinence during study weeks 11 and 12
To be scored as abstinent for the last two weeks of treatment, a participant must provide: 1. 14 days of self-reported use for weeks 11 and 12 with no self-reported cocaine use and 2. provide at least 2 urine samples per week for study weeks 11 and 12 with all urine results negative for BE (BE<300 ng/mL). Any participant failing to meet these criteria will be scored as not abstinent. At a group level, this outcome translates into the proportion of participants in each treatment arm who are cocaine abstinent during the last two weeks of treatment.
Measured: Week 11 and Week 12
Number of participants with nephrotoxic effects as measured by urinalysis
Because this is the first outpatient study of D-serine being conducted for cocaine dependence and because cocaine can be nephrotoxic, possible nephrotoxic effects will be monitored carefully by completing microscopic urinalysis on a weekly basis.
Measured: Study week 13
Change from baseline in liver function at 6 weeks
Quantitative analysis of participant blood samples will be performed to measure liver function. Liver function will be determined by analysis of the following:creatinine, alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT), gamma glutamyltranspeptidase (GGT), and blood urea nitrogen (BUN).
Measured: Baseline and Week 6
Change from baseline in liver function at Week 12
Quantitative analysis of participant blood samples will be performed to measure liver function. Liver function will be determined by analysis of the following:creatinine, alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT), gamma glutamyltranspeptidase (GGT), and blood urea nitrogen (BUN).
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startFeb 2014
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: Funding was not received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cocaine 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theresa Winhusen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theresa Winhusen, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715051
- Sponsor's protocol ID
- TW-116541
- Acronym
- STED-CD
- Status last verified
- Feb 2014
- First submitted
- 9 Oct 2012
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Botreau F, Paolone G, Stewart J. d-Cycloserine facilitates extinction of a cocaine-induced conditioned place preference. Behav Brain Res. 2006 Sep 15;172(1):173-8. doi: 10.1016/j.bbr.2006.05.012. Epub 2006 Jun 12.
PubMed 16769132Paolone G, Botreau F, Stewart J. The facilitative effects of D-cycloserine on extinction of a cocaine-induced conditioned place preference can be long lasting and resistant to reinstatement. Psychopharmacology (Berl). 2009 Jan;202(1-3):403-9. doi: 10.1007/s00213-008-1280-y. Epub 2008 Aug 10.
PubMed 18695929Thanos PK, Bermeo C, Wang GJ, Volkow ND. D-cycloserine accelerates the extinction of cocaine-induced conditioned place preference in C57bL/c mice. Behav Brain Res. 2009 May 16;199(2):345-9. doi: 10.1016/j.bbr.2008.12.025. Epub 2008 Dec 30.
PubMed 19152811
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of D-Serine for Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01715051
- Acronym / sponsor ID
- STED-CD / TW-116541
- Conditions
- Cocaine Dependence
- Keywords
- cocaine, D-serine, Drug dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not received
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Theresa WinhusenUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 26 Oct 2012 (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 primary objective of this study is to collect pilot data on the efficacy of D-serine, relative to placebo, as a cocaine dependence treatment. Secondary objectives include evaluating D-serine, relative to placebo, on: 1. safety in treating cocaine-dependent adults and 2. tolerability.
Detailed description
STUDY DESIGN. This is a 12 week, 2 group randomized controlled trial that will be completed in an outpatient setting. Eligible participants will be randomized to D-serine or matching placebo and will be scheduled to attend three research visits per week throughout the active treatment phase which begins with randomization and ends on day 7 of study week 12. A single visit will be scheduled in week 13 to complete retrospective data for week 12. Participants will receive D-serine or placebo throughout the 12-week active treatment phase. Randomization will be in a 1:1 ratio, stratified by cocaine use frequency (<10 days or ≥ 10 days in the 28 days prior to consent).
STUDY POPULATION. Approximately 80 participants recruited from a single site will be randomized. The study population will include adults who meet Diagnostic and Statistical Manual-IV-Text Revision (DSM-IV-TR) criteria for cocaine dependence who have used cocaine in the 30 days prior to consent and who provide at least one benzoylecgonine (BE) positive urine during screening/baseline.
TREATMENTS. Study participants will be randomly assigned to receive either D-serine (target ~60 mg/kg per day) or matching placebo. All participants will receive once weekly manual-guided cognitive behavioral therapy during the 12 week treatment period. Medication adherence will be assessed with the Medication Events Monitoring System (MEMS).
EFFICACY ASSESSMENTS. The primary outcome measure will be cocaine abstinence for three or more consecutive weeks, with abstinence during a week defined as self-report of no cocaine use during the week as well as negative urine BE (BE<300 ng/mL) results during the week with at least two urine samples provided. Key secondary efficacy measures include the proportion of urine BE negative results obtained and cocaine abstinence during study weeks 11 and 12 as measured by self-report and urine BE. Other efficacy measures include drug attention bias, cocaine craving, drug compulsivity, cocaine withdrawal symptoms, and treatment retention.
SAFETY ASSESSMENTS. Safety measures include urinalysis, adverse events (AEs), vitals, electrocardiogram (ECG), and laboratory tests. Tolerability will be assessed by the proportion of participants needing a dose reduction and being discontinued from study medication.
ANALYSIS. Each outcome variable will be analyzed using appropriate statistical methods for the intention-to-treat (ITT) population and the evaluable population. All participants who have taken at least one study medication dose will be included in the safety analysis. Data will be summarized by treatment group. Summary statistics will include the mean, sample size, standard deviation, median, minimum and maximum values for continuous variables, and frequencies and percentages for categorical variables.
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 |
|---|---|---|
| D-serine | Active comparator | Drug: D-serine, Behavioral: Cognitive Behavioral TherapyParticipants randomized to D-serine will receive 500 mg tablets of D-serine based on the participant's weight in addition to weekly cognitive behavioral therapy (CBT). The number of capsules prescribed will be based on the target ~60 mg/kg per day dose. In practice, the mg/kg daily dose will range between approximately 55 mg/kg and 65 mg/kg. Dosing will be bid. |
| Placebo | Placebo comparator | Behavioral: Cognitive Behavioral Therapy, Drug: PlaceboThe number of placebo capsules prescribed to a study participant per day will be based on the participant's weight and will be bid dosing to match the dosing of D-serine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- be 18 years of age or older
- be able to understand the study, and having understood, provide written informed consent in English
- meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) dependence for cocaine,
- have at least 1 positive urine BE specimen (> 300 ng/mL) during screening/baseline with a minimum of 3 urine samples tested if screening/baseline is completed within 7 days or a minimum of 4 urine samples tested if screening/baseline is completed during a period >7 days and ≤ 14 days
- have a willingness to comply with all study procedures and medication instructions
Key exclusion criteria (18 listed)
- have current dependence, defined by DSM-IV-TR criteria, on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
- have been enrolled in a medication assisted treatment program for opioid dependence (e.g., methadone, buprenorphine) within 2 months of consent.
- have a medical or psychiatric condition that, in the judgment of the study physician, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to:
- have initiated or had a dose change in psychotropic medication in the 28 days prior to randomization if currently taking psychotropic medication
- have a known or suspected hypersensitivity to D-serine
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 |
|---|---|---|
| D-serineThe molecular formula for D-serine is C3H7NO3. D-serine is being used in IND# 71,369 (D Javitt, PI) and in IND#76,940 (H Singer, PI). This approved D-serine will be purchased by the Research Pharmacy at Johns Hopkins and will be encapsulated into capsules containing 500 mg of D-serine. | Drug | D-serine |
| Cognitive Behavioral TherapyCBT sessions will be offered weekly to both active medication and placebo arms. The National Institute on Drug Abuse (NIDA) published CBT treatment manual for cocaine dependence, written by Kathleen Carroll, Ph.D., will be utilized. The skills taught in this CBT manual include (1) self-monitoring and functional analysis of situational factors associated with craving or drug use; (2) learning alternative non-drug responses for handling high risk situations; and (3) general lifestyle modifications (e.g., increasing pleasant drug-free events, anger management, interpersonal skills, general problem-solving). | Behavioural | D-serine, Placebo |
| PlaceboAlso: Sugar PillThe Research Pharmacy at Johns Hopkins will produce matching placebo capsules. | Drug | Placebo |
Primary outcome
Proportion of participants with cocaine abstinence for three or more consecutive weeks as assessed by self-report and urine BE
Time frame: Week 13 visit
The Timeline Follow-back (TLFB) procedure will be used to assess the participants' self-reported use of substances for each day of the study. Urine samples will be collected at each study visit using temperature monitoring and the validity of urine samples will be checked with the use of a commercially available adulterant test. The urine samples will be sent to a laboratory for analysis. The self-report and urine BE results will be combined to score each participant as cocaine abstinent or non-abstinent for each study week.
5 secondary outcomes
Proportion of cocaine-negative Urine Drug Screens (UDS) during the treatment phase
Time frame: Week 13 visit
Proportion of participants achieving cocaine abstinence during study weeks 11 and 12
Time frame: Week 11 and Week 12
Number of participants with nephrotoxic effects as measured by urinalysis
Time frame: Study week 13
Change from baseline in liver function at 6 weeks
Time frame: Baseline and Week 6
Change from baseline in liver function at Week 12
Time frame: Baseline and Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Background: PubMed 16769132Botreau F, Paolone G, Stewart J. d-Cycloserine facilitates extinction of a cocaine-induced conditioned place preference. Behav Brain Res. 2006 Sep 15;172(1):173-8. doi: 10.1016/j.bbr.2006.05.012. Epub 2006 Jun 12.
- Background: PubMed 18695929Paolone G, Botreau F, Stewart J. The facilitative effects of D-cycloserine on extinction of a cocaine-induced conditioned place preference can be long lasting and resistant to reinstatement. Psychopharmacology (Berl). 2009 Jan;202(1-3):403-9. doi: 10.1007/s00213-008-1280-y. Epub 2008 Aug 10.
- Background: PubMed 19152811Thanos PK, Bermeo C, Wang GJ, Volkow ND. D-cycloserine accelerates the extinction of cocaine-induced conditioned place preference in C57bL/c mice. Behav Brain Res. 2009 May 16;199(2):345-9. doi: 10.1016/j.bbr.2008.12.025. Epub 2008 Dec 30.
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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.
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 D-serine and Cognitive Behavioral Therapy in people with Cocaine Dependence, run by Theresa Winhusen 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 16 inclusion and 18 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: withdrawn, as of the sponsor's last update on 6 Feb 2014. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of participants with cocaine abstinence for three or more consecutive weeks as assessed by self-report and urine BE (time frame: Week 13 visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715051, which also lists 3 linked publications.
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 6 Feb 2014; AzTrials last refreshed its copy on 30 Oct 2026.