Alcohol DrinkingPhase 1/2NCT00695500
Varenicline to Reduce Alcohol Consumption in Heavy Drinkers
A Phase 1/2 study testing Varenicline in people with Alcohol Drinking, run by Vijay Ramchandani, Ph.D. at 1 site in United States.
Trial summary
This study will determine whether varenicline, a drug that acts on the brain's nicotine receptors and is used to help smokers stop smoking, will have an impact on alcohol self-administration. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2015
- Phase
- Phase 1/2
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21 to 60 years of age.
- In good health.
- Drink a weekly average of 15 and 20 standard alcoholic drinks (12 gm ethanol/beverage), respectively, for women and men.
- Have a working phone number.
Who cannot join
- Currently seeking help for an alcohol problem.
- Subjects with clinically significant alcohol withdrawal.
- More than thirty days of abstinence from alcohol in the ninety days prior to enrollment.
- A positive breath alcohol concentration (BrAC) at the first visit
- A history of major alcohol-related complications at any time, such as pancreatitis.
- Any serious cardiovascular condition or high risk factors, evidenced by any of the following:
Show all 21Show fewer
- Current or past diagnosis of coronary artery disease (such as ischemia, angina, congestive heart failure, myocardial infarction) or peripheral arterial disease;
- Current or past diagnosis of diabetes, or casual glucose level > 200 mg/dl;
- Elevated blood pressure (above 160/100) at screening,
- Elevated lipid levels: LDL > 160 mg/dL, HDL < 40 mg/dL for males or < 45 mg/dL for females;
- Clinically significant ECG abnormalities or unstable arrhythmias.
- Contraindication(s) to take the study medication as listed in the package insert.
- Contraindication(s) to take the study medication as listed in the package insert.
- Psychiatric problems requiring clinical attention: a current or past diagnosis of major depression, panic disorder, eating disorders, post traumatic stress disorder, schizophrenia, bipolar disorder, or obsessive compulsive disorder. Individuals who report lifetime (past or current) history of suicidal ideation, suicide attempts or self injury.
- Recent (within the last two months) or regular use of illicit or non-prescribed psycho-active substances such as opiates, benzodiazepines, cocaine, PCP, methamphetamines/other psychostimulants or marijuana.
- Psycho-social instability (e.g. no fixed address, no reliable secondary person to contact in case of an emergency).
- Women who are lactating, are trying to become pregnant or who are not willing to practice safe and effective birth control.
- Moderate-to-severe renal impairment defined as estimated or measured creatinine clearance less than 30 mL/min.
- Use of bupropion or nicotine replacement therapy within 90 days of the protocol, inhibitors/substrates for renal cationic transporters, or medications contraindicated with ethanol.
- Exclusion criteria for MRI scanning, including metal in body (such as implants, pacemaker, prostheses, shrapnel, irremovable piercing), left-handedness, and claustrophobia.
- A history of violence or aggression, assessed as part of the clinical interview at screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Trial (RCT) of Varenicline to Reduce Alcohol Consumption in Heavy Drinkers
This study will determine whether varenicline, a drug that acts on the brain's nicotine receptors and is used to help smokers stop smoking, will have an impact on alcohol self-administration.
People between 24 and 60 years of age who regularly consume alcoholic drinks (more than 15 drinks per week for women, and more than 20 drinks per week for men) may be eligible for this study. The study requires five outpatient visits and one overnight hospital admission at the NIH Clinical Center.
Read more
Participants undergo the following procedures:
Visit 1 (outpatient: 4-5 hours)
- Standard assessments, including vital signs measurements, breathalyzer test, blood and urine tests (including pregnancy test for females), questionnaires about mood, symptoms, alcohol use and smoking, if applicable
- Questionnaires about medical and psychological status
- Health assessment and assessment of alcohol drinking behavior
Visit 2 (outpatient: 8 hours)
- Standard assessments (see above)
- Computer-Assisted Self-infusion of Ethanol (CASE) session: Subjects will receive a priming intravenous infusion of alcohol. After 25 min, they will be allowed to give themselves additional exposures of alcohol over a period of 2 hours by pressing a button on a computer that controls the infusion pump.
Visit 3 (outpatient: 2 hours)
-Standard assessments
Visit 4 (outpatient: 8 hours)
- Standard assessments
- Brain functional magnetic resonance imaging scan (MRI). This test uses a magnetic field and radio waves to produce images of the brain. The patient lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud sounds that occur during the scanning process. Initial pictures are taken of the brain's structure and additional scans measure brain activity while the subject performs simple tasks.
- Alcohol Infusion. Subjects receive an intravenous infusion of alcohol while in the MRI scanner to measure the brain s response to alcohol.
Visit 5 (overnight)
- Standard assessments
- Repeat CASE session
- Interview about the subject's experiences participating in the protocol, including any symptoms and urges to drink
Visit 6 (outpatient)
- Standard assessments (without blood tests)
- Interview about participation in the study
Telephone follow-up
After 3 weeks, subjects are called to check on their symptoms and gather information on their drinking and, if applicable, smoking.
Read the detailed description
Objective:
Considerable clinical and experimental evidence in humans and animal models links nicotine use with heavy alcohol consumption. Varenicline, an alpha4beta2 (nicotinic) acetylcholine receptor (nAchR) partial agonist, is an oral medication approved by the FDA (2006) for smoking cessation. Recently, it has been shown to reduce alcohol consumption in a rodent model of alcohol dependence. In the present short-term experimental study, it will be assessed primarily for its ability to reduce alcohol self-administration in heavy drinkers. Secondarily, its effects on alcohol urges (cravings), as well as smoking parameters will be measured. In addition, effects of varenicline on incentive motivation for alcohol and the underlying brain reward system activation, as well as on activation of brain reward systems in response to intravenously administered alcohol will be measured.
Study Population:
Fifty healthy, adults (smokers and non-smokers), age 21 to 60 years, will be studied. Individuals must drink alcohol regularly at a heavy level, on average greater than 20 drinks per week for men, and greater than 15 drinks per week for women, and not be seeking help for alcohol-related problems.
Design:
Following protocol screening and medical evaluation, qualified subjects will undergo an initial ( pre-study drug ) intravenous alcohol self-administration session (hereafter, called computer-assisted self-infusion of ethanol, or CASE). Following this, subjects will be randomized to varenicline or placebo. Subjects will be clinically evaluated on three occasions while on study drug: once after one week of study medication; again, prior to the fMRI; and again, at the end of treatment, when they undergo the second ( on-study drug ) CASE session. Between days 13 and 21, all subjects will be scheduled to undergo functional magnetic resonance imaging (fMRI) of the brain while performing a task designed to evaluate the incentive salience for alcohol cues as well as the pharmacological effects of alcohol. Thereafter, all subjects will receive two courses of counseling for heavy drinking, using motivational enhancement techniques, aimed at enhancing their readiness for behavioral change and seeking treatment, if needed.
Outcome Measures:
The primary outcome will be the peak breath alcohol exposure achieved during the on-study drug CASE session. Secondary outcomes during the study drug phase will include measures of alcohol consumption, and urges to drink, as well as alcohol cravings and effects during the on-study drug CASE session. Additionally, fMRI BOLD responses in the ventral striatum, an area involved in brain reward circuitry and shown to be activated by acute IV alcohol administration as well as anticipation of working for reward will be measured. In smokers, cigarette use and quite rates as well as urges to smoke and nicotine withdrawal will also be measured. Safety and tolerability will be followed during the course of taking study drug with symptom checklists, profiles of mood and anxiety and by clinical interview. Serum varenicline concentrations will also be measured to assess compliance and control for potential pharmacokinetic variation.
- Conditions
- Alcohol Drinking
- Being tested
- Varenicline, Placebo
- Keywords
- Varenicline, Alcohol, Alcohol Use
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Varenicline tablets, 2 mg per day for 3 weeks
PlaceboDrug
Placebo tablets, 0 mg per day for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | Varenicline tablets, 2 mg per day for 3 weeks Receives: Drug: Varenicline |
| Placebo | Placebo comparator | Placebo tablets, 0 mg per day for 3 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption
Peak Breath Alcohol Concentration during IV alcohol self-administration
Measured: 2.5 hr session following 3 weeks of treatment
Secondary outcomes (1)
Alcohol Urges
Peak Alcohol Urge Questionnaire Score during IV alcohol self-administration. Scale: Alcohol Urge Questionnaire. Contains 8 items, each item scored on a likert scale from 1 to 7.
Range: Total scores range between 8 and 64. Higher scores indicate higher urges for alcohol.
Measured: 2.5 hr session following 3 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2014
- Study completionJun 2015
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vijay Ramchandani, Ph.D.
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Vijay Ramchandani, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Vijay A Ramchandani, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695500
- Sponsor's protocol ID
- 080137
- Other IDs
- 08-AA-0137
- Status last verified
- Jul 2016
- First submitted
- 11 Jun 2008
- Last updated
- 15 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lachin JM, Matts JP, Wei LJ. Randomization in clinical trials: conclusions and recommendations. Control Clin Trials. 1988 Dec;9(4):365-74. doi: 10.1016/0197-2456(88)90049-9.
PubMed 3203526Wei LJ, Lachin JM. Properties of the urn randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):345-64. doi: 10.1016/0197-2456(88)90048-7.
PubMed 3203525Falk DE, Yi HY, Hiller-Sturmhofel S. An epidemiologic analysis of co-occurring alcohol and tobacco use and disorders: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. Alcohol Res Health. 2006;29(3):162-71.
PubMed 17373404Gowin JL, Vatsalya V, Westman JG, Schwandt ML, Bartlett S, Heilig M, Momenan R, Ramchandani VA. The Effect of Varenicline on the Neural Processing of Fearful Faces and the Subjective Effects of Alcohol in Heavy Drinkers. Alcohol Clin Exp Res. 2016 May;40(5):979-87. doi: 10.1111/acer.13046. Epub 2016 Apr 8.
PubMed 27062270
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Trial (RCT) of Varenicline to Reduce Alcohol Consumption in Heavy Drinkers
- ClinicalTrials.gov ID
- NCT00695500
- Acronym / sponsor ID
- 080137
- Conditions
- Alcohol Drinking
- Keywords
- Varenicline, Alcohol, Alcohol Use
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vijay Ramchandani, Ph.D.US National Institutes of Health
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jun 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jun 2008 (estimated)
- Results
- Posted 15 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether varenicline, a drug that acts on the brain's nicotine receptors and is used to help smokers stop smoking, will have an impact on alcohol self-administration.
People between 24 and 60 years of age who regularly consume alcoholic drinks (more than 15 drinks per week for women, and more than 20 drinks per week for men) may be eligible for this study. The study requires five outpatient visits and one overnight hospital admission at the NIH Clinical Center.
Participants undergo the following procedures:
Visit 1 (outpatient: 4-5 hours)
- Standard assessments, including vital signs measurements, breathalyzer test, blood and urine tests (including pregnancy test for females), questionnaires about mood, symptoms, alcohol use and smoking, if applicable
- Questionnaires about medical and psychological status
- Health assessment and assessment of alcohol drinking behavior
Visit 2 (outpatient: 8 hours)
- Standard assessments (see above)
- Computer-Assisted Self-infusion of Ethanol (CASE) session: Subjects will receive a priming intravenous infusion of alcohol. After 25 min, they will be allowed to give themselves additional exposures of alcohol over a period of 2 hours by pressing a button on a computer that controls the infusion pump.
Visit 3 (outpatient: 2 hours)
-Standard assessments
Visit 4 (outpatient: 8 hours)
- Standard assessments
- Brain functional magnetic resonance imaging scan (MRI). This test uses a magnetic field and radio waves to produce images of the brain. The patient lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud sounds that occur during the scanning process. Initial pictures are taken of the brain's structure and additional scans measure brain activity while the subject performs simple tasks.
- Alcohol Infusion. Subjects receive an intravenous infusion of alcohol while in the MRI scanner to measure the brain s response to alcohol.
Visit 5 (overnight)
- Standard assessments
- Repeat CASE session
- Interview about the subject's experiences participating in the protocol, including any symptoms and urges to drink
Visit 6 (outpatient)
- Standard assessments (without blood tests)
- Interview about participation in the study
Telephone follow-up
After 3 weeks, subjects are called to check on their symptoms and gather information on their drinking and, if applicable, smoking.
Detailed description
Objective:
Considerable clinical and experimental evidence in humans and animal models links nicotine use with heavy alcohol consumption. Varenicline, an alpha4beta2 (nicotinic) acetylcholine receptor (nAchR) partial agonist, is an oral medication approved by the FDA (2006) for smoking cessation. Recently, it has been shown to reduce alcohol consumption in a rodent model of alcohol dependence. In the present short-term experimental study, it will be assessed primarily for its ability to reduce alcohol self-administration in heavy drinkers. Secondarily, its effects on alcohol urges (cravings), as well as smoking parameters will be measured. In addition, effects of varenicline on incentive motivation for alcohol and the underlying brain reward system activation, as well as on activation of brain reward systems in response to intravenously administered alcohol will be measured.
Study Population:
Fifty healthy, adults (smokers and non-smokers), age 21 to 60 years, will be studied. Individuals must drink alcohol regularly at a heavy level, on average greater than 20 drinks per week for men, and greater than 15 drinks per week for women, and not be seeking help for alcohol-related problems.
Design:
Following protocol screening and medical evaluation, qualified subjects will undergo an initial ( pre-study drug ) intravenous alcohol self-administration session (hereafter, called computer-assisted self-infusion of ethanol, or CASE). Following this, subjects will be randomized to varenicline or placebo. Subjects will be clinically evaluated on three occasions while on study drug: once after one week of study medication; again, prior to the fMRI; and again, at the end of treatment, when they undergo the second ( on-study drug ) CASE session. Between days 13 and 21, all subjects will be scheduled to undergo functional magnetic resonance imaging (fMRI) of the brain while performing a task designed to evaluate the incentive salience for alcohol cues as well as the pharmacological effects of alcohol. Thereafter, all subjects will receive two courses of counseling for heavy drinking, using motivational enhancement techniques, aimed at enhancing their readiness for behavioral change and seeking treatment, if needed.
Outcome Measures:
The primary outcome will be the peak breath alcohol exposure achieved during the on-study drug CASE session. Secondary outcomes during the study drug phase will include measures of alcohol consumption, and urges to drink, as well as alcohol cravings and effects during the on-study drug CASE session. Additionally, fMRI BOLD responses in the ventral striatum, an area involved in brain reward circuitry and shown to be activated by acute IV alcohol administration as well as anticipation of working for reward will be measured. In smokers, cigarette use and quite rates as well as urges to smoke and nicotine withdrawal will also be measured. Safety and tolerability will be followed during the course of taking study drug with symptom checklists, profiles of mood and anxiety and by clinical interview. Serum varenicline concentrations will also be measured to assess compliance and control for potential pharmacokinetic variation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: VareniclineVarenicline tablets, 2 mg per day for 3 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets, 0 mg per day for 3 weeks |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 21 to 60 years of age.
- In good health.
- Drink a weekly average of 15 and 20 standard alcoholic drinks (12 gm ethanol/beverage), respectively, for women and men.
- Have a working phone number.
Key exclusion criteria (21 listed)
- Currently seeking help for an alcohol problem.
- Subjects with clinically significant alcohol withdrawal.
- More than thirty days of abstinence from alcohol in the ninety days prior to enrollment.
- A positive breath alcohol concentration (BrAC) at the first visit
- A history of major alcohol-related complications at any time, such as pancreatitis.
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 |
|---|---|---|
| VareniclineVarenicline tablets, 2 mg per day for 3 weeks | Drug | Varenicline |
| PlaceboPlacebo tablets, 0 mg per day for 3 weeks | Drug | Placebo |
Primary outcome
Alcohol Consumption
Time frame: 2.5 hr session following 3 weeks of treatment
Peak Breath Alcohol Concentration during IV alcohol self-administration
1 secondary outcome
Alcohol Urges
Time frame: 2.5 hr session following 3 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3203526Lachin JM, Matts JP, Wei LJ. Randomization in clinical trials: conclusions and recommendations. Control Clin Trials. 1988 Dec;9(4):365-74. doi: 10.1016/0197-2456(88)90049-9.
- Background: PubMed 3203525Wei LJ, Lachin JM. Properties of the urn randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):345-64. doi: 10.1016/0197-2456(88)90048-7.
- Background: PubMed 17373404Falk DE, Yi HY, Hiller-Sturmhofel S. An epidemiologic analysis of co-occurring alcohol and tobacco use and disorders: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. Alcohol Res Health. 2006;29(3):162-71.
- Derived from this study: PubMed 27062270Gowin JL, Vatsalya V, Westman JG, Schwandt ML, Bartlett S, Heilig M, Momenan R, Ramchandani VA. The Effect of Varenicline on the Neural Processing of Fearful Faces and the Subjective Effects of Alcohol in Heavy Drinkers. Alcohol Clin Exp Res. 2016 May;40(5):979-87. doi: 10.1111/acer.13046. Epub 2016 Apr 8.
- Individual participant dataSharing planned: No
Related trials for Alcohol Drinking
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
Vijay A Ramchandani, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Varenicline in people with Alcohol Drinking, run by Vijay Ramchandani, Ph.D. 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 4 inclusion and 21 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 15 Aug 2016. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 15 Aug 2016). 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?
Alcohol Consumption (time frame: 2.5 hr session following 3 weeks of treatment). 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 NCT00695500, which also lists 4 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 15 Aug 2016.