Alcohol DependenceEarly Phase 1NCT00667771
The Effect of Naltrexone on Alcohol Craving and on Brain Activity During Alcohol Infusion
A Early Phase 1 study testing Naltrexone in people with Alcohol Dependence and Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
This study will determine whether naltrexone, a medicine used to treat alcoholism, can lessen the craving for alcohol during alcohol withdrawal and examine how the drug affects brain activity during alcohol infusion. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Alcohol Dependence, Alcoholism
- What is being tested?
- Naltrexone
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2008to 4 Apr 2011
- Phase
- Early Phase 1
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All participants must:
- be right-handed
- between 21 and 50 years of age
- meet the DSM-IV diagnostic criteria for alcohol dependence (polysubstance abuse is common in younger alcohol-dependent patients, and will not be exclusionary)
- have a positive family history of alcoholism (one or more first-degree relatives with alcohol problems)
- In addition, female participants:
- must have a negative urine pregnancy test (beta-hCG)
- of childbearing capability will be required to use a double contraceptive method (such as oral contraceptives, condom with spermicide or intra-uterine device with spermicide) from the start of the study until at least one month following the last dose of NTX.
Who cannot join
- General exclusion criteria for the NIAAA Intramural treatment program:
- people who present with complicated medical problems requiring intensive medical or diagnostic management, such as uncontrolled hypertension, gastro-intestinal (GI) bleeding, major organ or body system dysfunction or thyroid disease
- people who are infected with human immunodeficiency virus (HIV)
- serious neuro-psychiatric conditions which impair judgment or cognitive function to an extent that precludes them from providing informed consent or complying with study procedures, such as psychotic illness, or severe dementia (individuals not competent to give informed consent)
- people who are unlikely or unable to complete the study because they 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
Show all 18Show fewer
- Specific exclusion criteria for this protocol include:
- clinically significant hepatobiliary disease
- a history of facial flushing in response to alcohol
- a history of seizures
- currently psychotic
- currently abusing opioids
- use of psychotropic medications (antidepressant, lithium, antipsychotic, anxiolytic, antiepileptic) regularly within the last 4 weeks prior to admission
- having a positive pregnancy test, contemplating pregnancy in the next 3 months, nursing, or not using an effective contraceptive method (if the participant is of child-bearing potential)
- a history of allergy or unusual reactions to NTX
- have received treatment with NTX in the six-month period prior to enrollment
- presence of ferromagnetic brain aneurysm clips, implanted pacemaker, hearing aid, or any other metallic implant, such as pins, screws, plates, dentures, or non-removable jewelry, in or on the body
- pronounced claustrophobia
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: Effect of Naltrexone on Craving and Ethanol-Induced Brain Activity
This study will determine whether naltrexone, a medicine used to treat alcoholism, can lessen the craving for alcohol during alcohol withdrawal and examine how the drug affects brain activity during alcohol infusion.
People between 21 and 50 years of age who are right-handed, alcohol-dependent, and have at least one family member with a history of alcoholism, may be eligible for this study.
Read more
Participants are admitted to the NIH Clinical Center for 1 month for the following procedures:
Screening
- Medical history, alcohol-use history and family history of alcoholism
- Physical examination, psychological tests and blood tests
- Medicine to lessen alcohol withdrawal symptoms, if necessary
Days 1-7
- Alcohol detoxification
- Medical and psychological evaluations
- Assignment to naltrexone or placebo group
Days 7 through 28
- Drug treatment: Take naltrexone or placebo capsule every morning
- Additional alcohol-dependence treatment: Cognitive and behavioral therapies and participation in self-help groups, such as Alcoholics Anonymous
- Weekly questionnaires to measure mood and desire for alcohol
- Blood tests
- Alcohol craving stimulation test (day 7): Subjects handle and sniff water and then their favorite alcoholic beverage. They then rate their urge to drink alcohol and their level of anxiety and their heart rate is measured.
- Alcohol infusion test (day 9): Subjects have an MRI scan during infusion through a vein of saline (salt water), followed by infusion of alcohol. For this test, a catheter (plastic tube) is placed in a vein in each arm, one for administering the saline and then alcohol; the other for drawing blood samples to measure blood alcohol level and body chemistries. Before, during and after the infusion, subjects are asked to respond to questions about their feelings, cravings and mood changes.
Follow-up
Subjects are asked to participate in a 3-month outpatient assessment program involving five outpatient visits (at 1, 2, 4, 8 and 12 weeks after discharge). At each visit, they fill out questionnaires and to take a breathalyzer test and blood and urine tests for drugs. They may continue naltrexone therapy and weekly group therapy sessions during this time. Subjects who do not participate in the assessment program are contacted at home by phone once a week for 1 month and then every other week for the next 2 months to monitor alcohol abstinence.
...
Read the detailed description
Alcoholism is a chronic, progressive, brain disorder with a profound impact on individuals' lives and economic cost to society. The positive reinforcing effect of alcohol is a key element in the transitional development from alcohol intake to alcohol addiction. Findings from animal and human studies indicate that the rewarding properties of ethanol arise in part from a complex interaction between alcohol, endogenous opioids, and dopamine (DA) systems. Acute administration of ethanol increases the release of opioid peptides, which in turn, increases the release of DA in the mesocorticolimbic system. Naltrexone (NTX), an opioid receptor antagonist, has been studied widely in both preclinical and clinical research for the treatment of alcoholism. Numerous clinical studies have shown that short-term use of NTX on alcohol-dependent patients effectively prevents relapse and reduces the level of craving. Genetic studies have suggested that individuals with mu-opioid receptors (OPRMs) encoded by the 118G gain-of function variant allele experience a greater therapeutic response to NTX. There are no data utilizing functional Magnetic Resonance Imaging (fMRI) to study the effect of NTX on brain activity during an intravenous (IV) infusion of ethanol.
Objectives:
To study the effect of NTX on the blood oxygen level dependent (BOLD) response in the ventral striatum area of the brain in response to an ethanol infusion.
To study the effect of NTX on cue reactivity (CR) to alcohol-associated cues.
Study population:
Alcohol-dependent patients between the ages of 21-50 years.
Design:
All participants will complete a screening telephone interview before coming to the NIAAA Inpatient Unit. The interviewer will inform eligible participants about the requirements and procedures associated with current protocols. Following admission to NIAAA Inpatient Unit, all participants will be enrolled in the Assessment and Treatment of People with Alcohol Drinking Problems protocol (#05-AA-0121). Protocol 05-AA-0121 will allow us to evaluate each participant's general medical and psychiatric conditions and provide standard of care for treatment seeking alcoholics.
Participants, who fulfill the specific requirements of the NTX protocol, will be thoroughly informed about the nature of the study before obtaining an informed consent. Consented participants will be randomized, using a double-blind design, to receive either 50 mg of NTX per day or placebo. Medications will be administered at 8:00 AM on a daily basis by the nursing staff.
Prior to the challenge procedures (CR on Day 7 and fMRI/ethanol infusion on Day 9), a clinical nurse specialist who is not involved with the protocol will re-consent each participant when they are not in acute withdrawal. The re-consenting process will provide reassurance that participants understand the requirements and implications associated with participation in the CR and fMRI/ethanol infusion procedures. Individuals who elect not to participate in the CR and fMRI/ethanol infusion sessions will be discharged from the in-patient unit and encouraged to continue treatment in the NIAAA Outpatient Clinic for the next three months.
Participants who elect to remain in the study will take part in the CR session on Day 7 and fMRI/ethanol infusion session on Day 9 (procedures are described on Page 13 under study procedures). Following the fMRI/ethanol infusion session, participants will remain in the hospital for approximately three weeks to monitor their craving and take part in our inpatient treatment program for alcoholism. During the post-challenge hospitalization, all participants will be offered 50 mg of NTX once a day. Following discharge from the hospital, participants will be encouraged to continue treatment in NIAAA Outpatient Clinic for three months.
Outcome Measures:
BOLD response during the ethanol infusion challenge.
BOLD brain response to emotional facial stimuli.
Self-reported Alcohol Urge Questionnaires (AUQ), Penn Alcohol Craving Scale (PACS), Obsessive Compulsive Drinking Scale (OCDS) and Profile of Mood Status (POMS).
Hormonal responses to the ethanol challenge: plasma ACTH, cortisol, and beta-endorphin.
Subjective responses to the ethanol challenge as rated by stimulation, sedation, high, and intoxication questionnaires.
Cue-induced craving during the CR session.
- Conditions
- Alcohol Dependence, Alcoholism
- Being tested
- Naltrexone
- Keywords
- Alcohol, Naltrexone, fMRI, Alcoholism, Alcoholics, Alcohol Dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD response during the ethanol infusion challenge
Secondary outcomes (1)
Self-reported AUQ, PACS, OCDS, POMS and cue-induced craving during the CR session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study start22 Apr 2008
- Primary completion27 Dec 2010
- Study completion4 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667771
- Sponsor's protocol ID
- 080125
- Other IDs
- 08-AA-0125
- Status last verified
- 4 Apr 2011
- First submitted
- 25 Apr 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Appel SB, Wise L, McDaid J, Koyama S, McElvain MA, Brodie MS. The effects of long chain-length n-alcohols on the firing frequency of dopaminergic neurons of the ventral tegmental area. J Pharmacol Exp Ther. 2006 Sep;318(3):1137-45. doi: 10.1124/jpet.106.105148. Epub 2006 Jun 1.
PubMed 16740620Barr CS, Schwandt M, Lindell SG, Chen SA, Goldman D, Suomi SJ, Higley JD, Heilig M. Association of a functional polymorphism in the mu-opioid receptor gene with alcohol response and consumption in male rhesus macaques. Arch Gen Psychiatry. 2007 Mar;64(3):369-76. doi: 10.1001/archpsyc.64.3.369.
PubMed 17339526Bart G, Kreek MJ, Ott J, LaForge KS, Proudnikov D, Pollak L, Heilig M. Increased attributable risk related to a functional mu-opioid receptor gene polymorphism in association with alcohol dependence in central Sweden. Neuropsychopharmacology. 2005 Feb;30(2):417-22. doi: 10.1038/sj.npp.1300598.
PubMed 15525999Spagnolo PA, Ramchandani VA, Schwandt ML, Zhang L, Blaine SK, Usala JM, Diamond KA, Phillips MJ, George DT, Momenan R, Heilig M. Effects of naltrexone on neural and subjective response to alcohol in treatment-seeking alcohol-dependent patients. Alcohol Clin Exp Res. 2014 Dec;38(12):3024-32. doi: 10.1111/acer.12581.
PubMed 25581657
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Naltrexone on Craving and Ethanol-Induced Brain Activity
- ClinicalTrials.gov ID
- NCT00667771
- Acronym / sponsor ID
- 080125
- Conditions
- Alcohol Dependence, Alcoholism
- Keywords
- Alcohol, Naltrexone, fMRI, Alcoholism, Alcoholics, Alcohol Dependence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 22 Apr 2008
- Primary completion
- 27 Dec 2010 (actual)
- Study completion
- 4 Apr 2011 (actual)
- First posted
- 28 Apr 2008 (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.
This study will determine whether naltrexone, a medicine used to treat alcoholism, can lessen the craving for alcohol during alcohol withdrawal and examine how the drug affects brain activity during alcohol infusion.
People between 21 and 50 years of age who are right-handed, alcohol-dependent, and have at least one family member with a history of alcoholism, may be eligible for this study.
Participants are admitted to the NIH Clinical Center for 1 month for the following procedures:
Screening
- Medical history, alcohol-use history and family history of alcoholism
- Physical examination, psychological tests and blood tests
- Medicine to lessen alcohol withdrawal symptoms, if necessary
Days 1-7
- Alcohol detoxification
- Medical and psychological evaluations
- Assignment to naltrexone or placebo group
Days 7 through 28
- Drug treatment: Take naltrexone or placebo capsule every morning
- Additional alcohol-dependence treatment: Cognitive and behavioral therapies and participation in self-help groups, such as Alcoholics Anonymous
- Weekly questionnaires to measure mood and desire for alcohol
- Blood tests
- Alcohol craving stimulation test (day 7): Subjects handle and sniff water and then their favorite alcoholic beverage. They then rate their urge to drink alcohol and their level of anxiety and their heart rate is measured.
- Alcohol infusion test (day 9): Subjects have an MRI scan during infusion through a vein of saline (salt water), followed by infusion of alcohol. For this test, a catheter (plastic tube) is placed in a vein in each arm, one for administering the saline and then alcohol; the other for drawing blood samples to measure blood alcohol level and body chemistries. Before, during and after the infusion, subjects are asked to respond to questions about their feelings, cravings and mood changes.
Follow-up
Subjects are asked to participate in a 3-month outpatient assessment program involving five outpatient visits (at 1, 2, 4, 8 and 12 weeks after discharge). At each visit, they fill out questionnaires and to take a breathalyzer test and blood and urine tests for drugs. They may continue naltrexone therapy and weekly group therapy sessions during this time. Subjects who do not participate in the assessment program are contacted at home by phone once a week for 1 month and then every other week for the next 2 months to monitor alcohol abstinence.
...
Detailed description
Alcoholism is a chronic, progressive, brain disorder with a profound impact on individuals' lives and economic cost to society. The positive reinforcing effect of alcohol is a key element in the transitional development from alcohol intake to alcohol addiction. Findings from animal and human studies indicate that the rewarding properties of ethanol arise in part from a complex interaction between alcohol, endogenous opioids, and dopamine (DA) systems. Acute administration of ethanol increases the release of opioid peptides, which in turn, increases the release of DA in the mesocorticolimbic system. Naltrexone (NTX), an opioid receptor antagonist, has been studied widely in both preclinical and clinical research for the treatment of alcoholism. Numerous clinical studies have shown that short-term use of NTX on alcohol-dependent patients effectively prevents relapse and reduces the level of craving. Genetic studies have suggested that individuals with mu-opioid receptors (OPRMs) encoded by the 118G gain-of function variant allele experience a greater therapeutic response to NTX. There are no data utilizing functional Magnetic Resonance Imaging (fMRI) to study the effect of NTX on brain activity during an intravenous (IV) infusion of ethanol.
Objectives:
To study the effect of NTX on the blood oxygen level dependent (BOLD) response in the ventral striatum area of the brain in response to an ethanol infusion.
To study the effect of NTX on cue reactivity (CR) to alcohol-associated cues.
Study population:
Alcohol-dependent patients between the ages of 21-50 years.
Design:
All participants will complete a screening telephone interview before coming to the NIAAA Inpatient Unit. The interviewer will inform eligible participants about the requirements and procedures associated with current protocols. Following admission to NIAAA Inpatient Unit, all participants will be enrolled in the Assessment and Treatment of People with Alcohol Drinking Problems protocol (#05-AA-0121). Protocol 05-AA-0121 will allow us to evaluate each participant's general medical and psychiatric conditions and provide standard of care for treatment seeking alcoholics.
Participants, who fulfill the specific requirements of the NTX protocol, will be thoroughly informed about the nature of the study before obtaining an informed consent. Consented participants will be randomized, using a double-blind design, to receive either 50 mg of NTX per day or placebo. Medications will be administered at 8:00 AM on a daily basis by the nursing staff.
Prior to the challenge procedures (CR on Day 7 and fMRI/ethanol infusion on Day 9), a clinical nurse specialist who is not involved with the protocol will re-consent each participant when they are not in acute withdrawal. The re-consenting process will provide reassurance that participants understand the requirements and implications associated with participation in the CR and fMRI/ethanol infusion procedures. Individuals who elect not to participate in the CR and fMRI/ethanol infusion sessions will be discharged from the in-patient unit and encouraged to continue treatment in the NIAAA Outpatient Clinic for the next three months.
Participants who elect to remain in the study will take part in the CR session on Day 7 and fMRI/ethanol infusion session on Day 9 (procedures are described on Page 13 under study procedures). Following the fMRI/ethanol infusion session, participants will remain in the hospital for approximately three weeks to monitor their craving and take part in our inpatient treatment program for alcoholism. During the post-challenge hospitalization, all participants will be offered 50 mg of NTX once a day. Following discharge from the hospital, participants will be encouraged to continue treatment in NIAAA Outpatient Clinic for three months.
Outcome Measures:
BOLD response during the ethanol infusion challenge.
BOLD brain response to emotional facial stimuli.
Self-reported Alcohol Urge Questionnaires (AUQ), Penn Alcohol Craving Scale (PACS), Obsessive Compulsive Drinking Scale (OCDS) and Profile of Mood Status (POMS).
Hormonal responses to the ethanol challenge: plasma ACTH, cortisol, and beta-endorphin.
Subjective responses to the ethanol challenge as rated by stimulation, sedation, high, and intoxication questionnaires.
Cue-induced craving during the CR session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- be right-handed
- between 21 and 50 years of age
- meet the DSM-IV diagnostic criteria for alcohol dependence (polysubstance abuse is common in younger alcohol-dependent patients, and will not be exclusionary)
- have a positive family history of alcoholism (one or more first-degree relatives with alcohol problems)
- must have a negative urine pregnancy test (beta-hCG)
Key exclusion criteria (18 listed)
- people who present with complicated medical problems requiring intensive medical or diagnostic management, such as uncontrolled hypertension, gastro-intestinal (GI) bleeding, major organ or body system dysfunction or thyroid disease
- people who are infected with human immunodeficiency virus (HIV)
- serious neuro-psychiatric conditions which impair judgment or cognitive function to an extent that precludes them from providing informed consent or complying with study procedures, such as psychotic illness, or severe dementia (individuals not competent to give informed consent)
- people who are unlikely or unable to complete the study because they 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
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 |
|---|---|---|
| Naltrexone | Drug | – |
Primary outcome
BOLD response during the ethanol infusion challenge
1 secondary outcome
Self-reported AUQ, PACS, OCDS, POMS and cue-induced craving during the CR session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 16740620Appel SB, Wise L, McDaid J, Koyama S, McElvain MA, Brodie MS. The effects of long chain-length n-alcohols on the firing frequency of dopaminergic neurons of the ventral tegmental area. J Pharmacol Exp Ther. 2006 Sep;318(3):1137-45. doi: 10.1124/jpet.106.105148. Epub 2006 Jun 1.
- Background: PubMed 17339526Barr CS, Schwandt M, Lindell SG, Chen SA, Goldman D, Suomi SJ, Higley JD, Heilig M. Association of a functional polymorphism in the mu-opioid receptor gene with alcohol response and consumption in male rhesus macaques. Arch Gen Psychiatry. 2007 Mar;64(3):369-76. doi: 10.1001/archpsyc.64.3.369.
- Background: PubMed 15525999Bart G, Kreek MJ, Ott J, LaForge KS, Proudnikov D, Pollak L, Heilig M. Increased attributable risk related to a functional mu-opioid receptor gene polymorphism in association with alcohol dependence in central Sweden. Neuropsychopharmacology. 2005 Feb;30(2):417-22. doi: 10.1038/sj.npp.1300598.
- Derived from this study: PubMed 25581657Spagnolo PA, Ramchandani VA, Schwandt ML, Zhang L, Blaine SK, Usala JM, Diamond KA, Phillips MJ, George DT, Momenan R, Heilig M. Effects of naltrexone on neural and subjective response to alcohol in treatment-seeking alcohol-dependent patients. Alcohol Clin Exp Res. 2014 Dec;38(12):3024-32. doi: 10.1111/acer.12581.
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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 Early Phase 1 study testing Naltrexone in people with Alcohol Dependence and 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 8 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: finished, as of the sponsor's last update on 2 Jul 2017. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD response during the ethanol infusion challenge. 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 NCT00667771, 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 2 Jul 2017.