AlcoholismPhase 2NCT00605904
Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics
A Phase 2 study testing Acamprosate, Yohimbine and mCPP in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
This study will determine if acamprosate, a drug approved to treat alcoholism, decreases alcohol cravings in alcohol-dependent subjects following infusions of yohimbine and mCPP. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Acamprosate, Yohimbine and mCPP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2011
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be 60 recently detoxified alcoholics according to the following criteria:
- DSM-IV diagnosis of alcohol dependence on SCID, alcohol problems as primary complaint among substance use disorder, and alcohol use within the last month.
- Spielberger trait anxiety (21) score greater than 39
- Age 21-65
- Females of childbearing potential must agree to use a reliable method of birth control during the study. Reliable methods of birth control include oral contraceptives or Norplant(Registered Trademark); barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices; a partner with a vasectomy; or abstinence from intercourse.
Who cannot join
- People who present with significant medical problems which in the assessment of the Lead Associate Investigator contraindicate administration of any of the study drugs. Examples are patients requiring intensive medical or diagnostic management, such as uncontrolled hypertension, serious GI bleeding, major organ or body system dysfunction such as decompensated liver disease, renal failure, myocardial ischemia, congestive heart failure or cerebrovascular disease, major endocrine problems such as uncontrolled diabetes, pancreatic or thyroid disease, or glaucoma.
- People who are infected with the Human Immunodeficiency Virus (HIV).
- People with the following specific neuro-psychiatric disorders: any psychotic disorder including schizophrenia; bipolar affective disorder; or panic disorder.
- People with any other condition that impairs judgment or cognitive function to an extent that precludes them from providing informed consent or complying with treatment (incompetent individuals); or that requires management with pharmacotherapy that would make the subject ineligible for participation.
- Contraindications for acamprosate (previously exhibited hypersensitivity to acamprosate calcium or any of its components; or severe renal impairment, manifested as creatinine clearance of 30 mL/min or less.
- Contraindications for yohimbine or mCPP, such as liver or renal disease; chronic inflammation of the sexual organs or prostate gland; history of gastric and duodenal ulcers; glaucoma; hypersensitivity to yohimbine or mCPP
Show all 10Show fewer
- People who are unlikely or unable to complete the treatment program because they become, or are likely to be, incarcerated while on the protocol.
- People who are required to receive treatment by a court of law or who are involuntarily committed to treatment.
- Pregnancy or lactation (negative pregnancy test required)
- Regular use of psychotropic medication, physician prescribed or purchased over the counter (e.g. antidepressant, lithium, antipsychotic, anxiolytic, antiepileptic, nasal decongestants in tablet form) or blood pressure medication (e.g. beta-blockers, calcium antagonists, ACE-inhibitors or AT1 antagonists) within the last 4 weeks, with the exception of benzodiazepines administered within the NIAAA program as part of alcohol withdrawal treatment. Specifically, no subject will be taken off psychoactive medications for the purpose of enrollment in this protocol.
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
This study will determine if acamprosate, a drug approved to treat alcoholism, decreases alcohol cravings in alcohol-dependent subjects following infusions of yohimbine and mCPP. Yohimbine causes anxiety and may provoke a desire for alcohol; mCPP induces a feeling of having had a few drinks, which often creates a desire for more drinks. If acamprosate can prevent a craving following these stimuli, then the effectiveness of new experimental drugs for treating alcoholism can be tested for their ability to block yohimbine or mCPP-induced cravings. This type of investigation would be less expensive and less time-consuming than conducting clinical trials with alcohol-dependent people.
People between 21 and 65 years of age who are alcohol-dependent and have been drinking regularly for at least 1 month before entering the study may be eligible to participate.
Read more
Participants are admitted to the NIH Clinical Center for about 35 days, during which time they are asked to participate in an alcohol treatment program. They may request passes to leave the hospital during the day but must return overnight. Upon return to the hospital, subjects are required to take a breathalyzer test for alcohol and urine screen for drug use. Participants found to have used drugs or consumed alcohol while away from the hospital are terminated from the study.
Participants are randomly assigned to take acamprosate or placebo pills three times a day for about 2 weeks. They are then given three intravenous (through a vein) infusions, 5 to 7 days apart, each containing either yohimbine, mCPP or placebo. The drugs are infused for 20 minutes following a 1-hour infusion of saline (salt water). Subjects complete two questionnaires - an alcohol urge questionnaire to assess the desire for alcohol and a PASS rating scale to assess anxiety - several times during the study and during the infusions....
Read the detailed description
Objective: The objective of the present study is to establish, in our laboratory, a published model of pharmacologically induced alcohol craving, and carry out an initial evaluation of its predictive validity for efficacy in treatment of alcoholism. Two pharmacological challenges are tested: 1. The alpha2-adrenergic antagonist yohimbine, which reliably induces reinstatement of alcohol seeking in experimental animals, but has produced less clear results in humans. 2. The serotonergic compound mCPP, which has been reported to robustly increase alcohol craving in human alcoholics, but for which animal data are less clear. Our objective study is to evaluate craving responses to infusion of yohimbine or mCPP using optimal assessment tools and subject population, and establish their sensitivity to the clinically effective alcoholism medication acamprosate.
Study Population: The study will be carried out in 60 subjects aged 21-65 years, with alcohol dependence as their primary complaint, and without other serious medical or psychiatric conditions. An additional inclusion criterion will be elevated trait anxiety as measured by the Spielberger Trait Anxiety Inventory. Subjects will be admitted to the NIAAA research inpatient unit at the NIH Clinical Research Center (CRC) through the platform training and natural history protocol (05-AA-0121 Assessment and Treatment of People with Alcohol Drinking Problems ), which provides basic assessments and standard withdrawal treatment if needed. Patients will enter into the present protocol once such treatment, if needed, is completed.
Design: Following inclusion, subjects will be randomized to acamprosate (n=25) or placebo (n=25), receiving either 3 tablets of 333mg acamprosate three times daily, or receiving identically looking placebo. Following a minimum of 2 weeks of treatment, subjects will undergo three challenge sessions, a minimum of 5 days apart, with yohimbine, m-CPP or placebo infusion, in counterbalanced order.
Outcome Measures: During the challenge sessions, subjective cravings for alcohol will be assessed using the Alcohol Urge Questionnaire. Neuroendocrine and cardiovascular measures will be collected for exploratory purposes.
- Conditions
- Alcoholism
- Being tested
- Acamprosate, Yohimbine, mCPP, Saline
- Keywords
- Chemical Stressor, Alcoholism, Yohimbine, Acamprosate, Craving
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamprosateDrug
Also called Campral
orally administered tablet, 333mg, three times daily for a minimum of 2 weeks (14 days)
YohimbineDrug
Also called Yohimbe, Yocon, Yohimex, Aphrodyne
Intravenous infusion of yohimbine (0.4 mg/kg) administered once over 10 minutes
mCPPDrug
Also called 3-CPP, CPP
Intravenous infusion of mCPP (0.05 mg/kg) over 10 minutes, two times, for a total of 0.1 mg/kg
SalineDrug
Also called Normal Saline Flush, Sodium Chloride
Intravenous infusion of 0.9% sodium chloride solution over 10 minutes, three times during the study (2 times for the "Saline Infusion" milestone, and one time immediately following the "Yohimbine Infusion" milestone)
| Study group | Role | What they receive |
|---|---|---|
| Acamprosate | Experimental | Subjects received 3 tablets of 333mg acamprosate orally, three times daily (total dose of 999 mg) for a minimum of 2 weeks. Receives: Drug: Acamprosate; Drug: Yohimbine; Drug: mCPP; Drug: Saline |
| Placebo | Placebo comparator | Subjects received 3 tablets of placebo orally, three times daily, for a minimum of 2 weeks. Receives: Drug: Yohimbine; Drug: mCPP; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Craving Rating in Response to Saline Infusion
Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.
Measured: 180 minutes after the start of the infusion
Alcohol Craving Rating in Response to Meta-Chlorophenylpiperazine
Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.
Measured: 180 minutes after the start of the infusion
Alcohol Craving Rating in Response to Yohimbine Infusion
Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.
Measured: 180 minutes after the start of the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2010
- Study completionMar 2011
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 (3)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Markus Heilig, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605904
- Sponsor's protocol ID
- 080058
- Other IDs
- 08-AA-0058
- Status last verified
- May 2012
- First submitted
- 30 Jan 2008
- Last updated
- 3 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Heilig M, Egli M. Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacol Ther. 2006 Sep;111(3):855-76. doi: 10.1016/j.pharmthera.2006.02.001. Epub 2006 Mar 20.
PubMed 16545872Heilig M, Koob GF. A key role for corticotropin-releasing factor in alcohol dependence. Trends Neurosci. 2007 Aug;30(8):399-406. doi: 10.1016/j.tins.2007.06.006. Epub 2007 Jul 16.
PubMed 17629579Bohn MJ, Krahn DD, Staehler BA. Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcohol Clin Exp Res. 1995 Jun;19(3):600-6. doi: 10.1111/j.1530-0277.1995.tb01554.x.
PubMed 7573780
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics
- ClinicalTrials.gov ID
- NCT00605904
- Acronym / sponsor ID
- 080058
- Conditions
- Alcoholism
- Keywords
- Chemical Stressor, Alcoholism, Yohimbine, Acamprosate, Craving
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Posted 3 Jul 2012
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 if acamprosate, a drug approved to treat alcoholism, decreases alcohol cravings in alcohol-dependent subjects following infusions of yohimbine and mCPP. Yohimbine causes anxiety and may provoke a desire for alcohol; mCPP induces a feeling of having had a few drinks, which often creates a desire for more drinks. If acamprosate can prevent a craving following these stimuli, then the effectiveness of new experimental drugs for treating alcoholism can be tested for their ability to block yohimbine or mCPP-induced cravings. This type of investigation would be less expensive and less time-consuming than conducting clinical trials with alcohol-dependent people.
People between 21 and 65 years of age who are alcohol-dependent and have been drinking regularly for at least 1 month before entering the study may be eligible to participate.
Participants are admitted to the NIH Clinical Center for about 35 days, during which time they are asked to participate in an alcohol treatment program. They may request passes to leave the hospital during the day but must return overnight. Upon return to the hospital, subjects are required to take a breathalyzer test for alcohol and urine screen for drug use. Participants found to have used drugs or consumed alcohol while away from the hospital are terminated from the study.
Participants are randomly assigned to take acamprosate or placebo pills three times a day for about 2 weeks. They are then given three intravenous (through a vein) infusions, 5 to 7 days apart, each containing either yohimbine, mCPP or placebo. The drugs are infused for 20 minutes following a 1-hour infusion of saline (salt water). Subjects complete two questionnaires - an alcohol urge questionnaire to assess the desire for alcohol and a PASS rating scale to assess anxiety - several times during the study and during the infusions....
Detailed description
Objective: The objective of the present study is to establish, in our laboratory, a published model of pharmacologically induced alcohol craving, and carry out an initial evaluation of its predictive validity for efficacy in treatment of alcoholism. Two pharmacological challenges are tested: 1. The alpha2-adrenergic antagonist yohimbine, which reliably induces reinstatement of alcohol seeking in experimental animals, but has produced less clear results in humans. 2. The serotonergic compound mCPP, which has been reported to robustly increase alcohol craving in human alcoholics, but for which animal data are less clear. Our objective study is to evaluate craving responses to infusion of yohimbine or mCPP using optimal assessment tools and subject population, and establish their sensitivity to the clinically effective alcoholism medication acamprosate.
Study Population: The study will be carried out in 60 subjects aged 21-65 years, with alcohol dependence as their primary complaint, and without other serious medical or psychiatric conditions. An additional inclusion criterion will be elevated trait anxiety as measured by the Spielberger Trait Anxiety Inventory. Subjects will be admitted to the NIAAA research inpatient unit at the NIH Clinical Research Center (CRC) through the platform training and natural history protocol (05-AA-0121 Assessment and Treatment of People with Alcohol Drinking Problems ), which provides basic assessments and standard withdrawal treatment if needed. Patients will enter into the present protocol once such treatment, if needed, is completed.
Design: Following inclusion, subjects will be randomized to acamprosate (n=25) or placebo (n=25), receiving either 3 tablets of 333mg acamprosate three times daily, or receiving identically looking placebo. Following a minimum of 2 weeks of treatment, subjects will undergo three challenge sessions, a minimum of 5 days apart, with yohimbine, m-CPP or placebo infusion, in counterbalanced order.
Outcome Measures: During the challenge sessions, subjective cravings for alcohol will be assessed using the Alcohol Urge Questionnaire. Neuroendocrine and cardiovascular measures will be collected for exploratory purposes.
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 |
|---|---|---|
| Acamprosate | Experimental | Drug: Acamprosate, Drug: Yohimbine, Drug: mCPP, Drug: SalineSubjects received 3 tablets of 333mg acamprosate orally, three times daily (total dose of 999 mg) for a minimum of 2 weeks. |
| Placebo | Placebo comparator | Drug: Yohimbine, Drug: mCPP, Drug: SalineSubjects received 3 tablets of placebo orally, three times daily, for a minimum of 2 weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DSM-IV diagnosis of alcohol dependence on SCID, alcohol problems as primary complaint among substance use disorder, and alcohol use within the last month.
- Spielberger trait anxiety (21) score greater than 39
- Age 21-65
- Females of childbearing potential must agree to use a reliable method of birth control during the study. Reliable methods of birth control include oral contraceptives or Norplant(Registered Trademark); barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices; a partner with a vasectomy; or abstinence from intercourse.
Key exclusion criteria (10 listed)
- People who present with significant medical problems which in the assessment of the Lead Associate Investigator contraindicate administration of any of the study drugs. Examples are patients requiring intensive medical or diagnostic management, such as uncontrolled hypertension, serious GI bleeding, major organ or body system dysfunction such as decompensated liver disease, renal failure, myocardial ischemia, congestive heart failure or cerebrovascular disease, major endocrine problems such as uncontrolled diabetes, pancreatic or thyroid disease, or glaucoma.
- People who are infected with the Human Immunodeficiency Virus (HIV).
- People with the following specific neuro-psychiatric disorders: any psychotic disorder including schizophrenia; bipolar affective disorder; or panic disorder.
- People with any other condition that impairs judgment or cognitive function to an extent that precludes them from providing informed consent or complying with treatment (incompetent individuals); or that requires management with pharmacotherapy that would make the subject ineligible for participation.
- Contraindications for acamprosate (previously exhibited hypersensitivity to acamprosate calcium or any of its components; or severe renal impairment, manifested as creatinine clearance of 30 mL/min or less.
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 |
|---|---|---|
| AcamprosateAlso: Campralorally administered tablet, 333mg, three times daily for a minimum of 2 weeks (14 days) | Drug | Acamprosate |
| YohimbineAlso: Yohimbe, Yocon, Yohimex, AphrodyneIntravenous infusion of yohimbine (0.4 mg/kg) administered once over 10 minutes | Drug | Acamprosate, Placebo |
| mCPPAlso: 3-CPP, CPPIntravenous infusion of mCPP (0.05 mg/kg) over 10 minutes, two times, for a total of 0.1 mg/kg | Drug | Acamprosate, Placebo |
| SalineAlso: Normal Saline Flush, Sodium ChlorideIntravenous infusion of 0.9% sodium chloride solution over 10 minutes, three times during the study (2 times for the "Saline Infusion" milestone, and one time immediately following the "Yohimbine Infusion" milestone) | Drug | Acamprosate, Placebo |
Primary outcome
Alcohol Craving Rating in Response to Saline Infusion
Time frame: 180 minutes after the start of the infusion
Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.
Alcohol Craving Rating in Response to Meta-Chlorophenylpiperazine
Time frame: 180 minutes after the start of the infusion
Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.
Alcohol Craving Rating in Response to Yohimbine Infusion
Time frame: 180 minutes after the start of the infusion
Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16545872Heilig M, Egli M. Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacol Ther. 2006 Sep;111(3):855-76. doi: 10.1016/j.pharmthera.2006.02.001. Epub 2006 Mar 20.
- Background: PubMed 17629579Heilig M, Koob GF. A key role for corticotropin-releasing factor in alcohol dependence. Trends Neurosci. 2007 Aug;30(8):399-406. doi: 10.1016/j.tins.2007.06.006. Epub 2007 Jul 16.
- Background: PubMed 7573780Bohn MJ, Krahn DD, Staehler BA. Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcohol Clin Exp Res. 1995 Jun;19(3):600-6. doi: 10.1111/j.1530-0277.1995.tb01554.x.
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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 Acamprosate, Yohimbine and mCPP in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 5 inclusion and 10 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 3 Jul 2012. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2012). 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 Craving Rating in Response to Saline Infusion (time frame: 180 minutes after the start of the infusion). 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?
On the ClinicalTrials.gov record for NCT00605904, 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 3 Jul 2012.