AlcoholismPhase 1NCT01738867

To Evaluate the Influence of the A118G Polymorphism in the mu Opioid Receptor Gene (OPRM1) on Effects of GSK1521498 and Naltrexone on Physiological and Behavioural Markers of Brain Function in Healthy Social Drinkers

A Phase 1 study testing GSK1521498 and Naltrexone (NTX) in people with Alcoholism, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A total of at least 48 healthy subjects with a history of social drinking will be recruited into this single-centre, randomized, double-blind, cross-over study. Subjects will be genetically stratified to result in equal numbers of A118G 'AA' homozygotes (n=24) and A118G 'G' carriers (n=24). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Alcoholism
What is being tested?: GSK1521498 and Naltrexone (NTX)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteUnited Kingdom
Study dates: 12 Dec 2012to 27 May 2014
Phase: 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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Caucasian male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent
BMI in the normal range or greater, which is equal to 22 kilogram (kg) per meter square (m^2) or above, but otherwise healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Self reported alcohol drinking frequency of 3 or more drinks for men (2 or more drinks for women) at least two days per week, on average or a score of 6 or higher on the Alcohol-Use-Disorders-Identification Test (AUDIT).
Aspartate aminotransferase (AST) and alanine transaminase (ALT) <2xUpper Limit of Normal (ULN); alkaline phosphatase and bilirubin <=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
A female subject is eligible to participate if she is of child-bearing potential and is abstinent or agrees to use one of the accepted contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 14 days after receiving the last dose of study medication.
Male subjects with female partners of child-bearing potential must agree to use one of the acceptable contraception methods. This criterion must be followed from the time of the first dose of study medication until 14 days after receiving the last dose of study medication.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form, and capacity to participate in all aspects of the assessment.

Who cannot join

Psychiatric illness and substance abuse:
Current or past history of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) alcohol or substance dependence or abuse, including treatment-seeking behaviour, as determined by the Investigator or Mini-international neuropsychiatric interview (MINI).
Self administered Beck Depression Inventory II scale total score greater than 13 or suicide question score greater than zero at screening.
Current or past chronic history of neurological disorders.
Current or past history of Axis 1 psychiatric disorders including eating disorders such as anorexia nervosa, bulimia nervosa and binge eating disorder, including treatment seeking behaviour using the MINI.
Subject who, in the investigator/designee's judgement, poses a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any evidence of suicidal ideation on any questionnaires e.g. type 4 or 5 on the C-SSRS in the last 5 years.

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Concomitant drug use: Positive urine screen for amphetamines, barbiturates, cocaine, opiates, cannabinoids or benzodiazepines at screening.
Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
Miscellaneous:
Special dietary requirements (e.g. vegetarians, vegans, religious, food -intolerantdiets), cannot be accommodated by the experimental design - it is important that all participants are offered the same test meals and snack choices during their in-unit assessments - so people with special dietary requirements will be excluded.
Subjects unsuitable for cannulation.
Any contraindications or logistical complications anticipated in relation to magnetic resonance imaging (MRI) scanning or other endpoint assessments, in the judgment of the Principal Investigator, including: presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies as assessed by a standard pre-MRI questionnaire, claustrophobia, inability to lie still on back for approximately an hour.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
QTcB or QTcF >450 milliseconds (msec). Note that if the initial QTc value is prolonged, the ECG should be repeated two more times (with 5 minutes between ECG readings) and the average of the 3 QTc values used to determine eligibility.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody or HIV tests result within 3 months of screening.
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within a 56 day period.
Pregnant or lactating females.
Occupational use of heavy machinery.
Heavy smokers i.e >15 cigarettes per day.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Cambridge, CB2 2GG

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Influence of the A118G Polymorphism in the mu Opioid Receptor Gene (OPRM1) on Effects of GSK1521498 and Naltrexone on Physiological and Behavioural Markers of Brain Function in Healthy Social Drinkers

Subjects will participate in all three treatment periods and will be randomized to receive each of the following for 5 days: Treatment A: Placebo, Treatment B: Naltrexone (NTX) 50 mg once daily (25 mg once daily for the first two days) and Treatment C: GSK1521498 10 mg once daily. A washout period will be of at least 14 days between treatments. Subjects will return for a follow-up visit 7-10 days after the final treatment session washout period has been completed.

Subjects will attend the clinical research unit on days 1, 2, 3, 4 and 5 to monitor safety and tolerability for both drugs. Subjects will attend the clinical unit on days 4 and 5 for a two day assessment, using a series of pharmacodynamic measurements known to be sensitive to the effects of GSK1521498 and/or NTX: Functional brain response to alcohol and food cues; plasma cortisol; hedonic and consummatory eating behaviors; subjective response to an ethanol challenge; experimental pain threshold; and cognitive tests of attention bias towards alcohol and food cues.

Conditions: Alcoholism
Being tested: GSK1521498, Naltrexone (NTX), Placebo
Keywords: Pharmacogenetics, OPRM1, Pharmacodynamics, Addiction, mu opioid receptors
Medical subject headings: Alcoholism, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK1521498Drug
White HPMC capsule containing 10 mg of GSK1521498
Naltrexone (NTX)Drug
Swedish orange gelatin capsule containing 25mg of NTX or 50mg of NTX
PlaceboDrug
Matching placebo capsules to GSK1521498 or NTX

Study groups in NCT01738867
Study group	Role	What they receive
Treatment A	Placebo comparator	Subject will receive oral dose of matching placebo once daily for 5 days in one of the 3 treatment periods. Receives: Drug: Placebo
Treatment B	Experimental	Subject will receive 25 mg orally once daily for the first two days and 50 mg once daily for 3 days in one of the 3 treatment periods. Receives: Drug: Naltrexone (NTX)
Treatment C	Experimental	Subject will receive 10 mg orally once daily for 5 days in one of the 3 treatment periods. Receives: Drug: GSK1521498

What is being measured

The primary outcome is the main question the study is designed to answer.

Brain activation within the reward circuitry in response to consumption of food and alcohol cues, as measured by functional magnetic resonance imaging (fMRI)
To test that the OPRM1 A118G polymorphism modulates the effects of GSK1521498 10 mg on brain reward function and processing
Measured: Day 5 in each treatment period
Adverse events as a measure of safety and tolerability
Number of subjects with any adverse events during the treatment periods
Measured: Throughout the study, from Day 1 to Day 67
Blood pressure (BP) as a measure of safety and tolerability
Systolic and diastolic BP will be measured
Measured: Screening (Up to 30 days prior to Day 1), Day 1, Day 2, Day 5 in each treatment period and Follow-up visit.
12-lead ECG and heart rate as a measure of safety and tolerability
12-lead electrocardiograph (ECG) will be measured
Measured: Screening (Up to 30 days prior to Day 1), Day 1, Day 2, Day 5 in each treatment period and Follow-up visit.
Clinical chemistry including liver enzymes and hematology as a measure of safety and tolerability
Hematology/Chemistry assessments to be done at screening (fasted) and day 5 for each treatment session (un-fasted).
Measured: Screening (Up to 30 days prior to Day 1), Day 5 of each of the 3 treatment periods and Follow-up visit
Psychiatric symptom questionnaires-Becks Depression & Anxiety Inventory (BDI-II & BAI)
Mood anxiety will be assessed by The Beck Anxiety Inventory (BAI), The Beck Depression Inventory (BDI-II).
Measured: Screening (Up to 30 days prior to Day 1), Day 1 (pre-dose and approximately 4 hours post dose), Day 2 (prior to discharge), Day 3 (prior to discharge), Day 5 (prior to discharge), in each treatment period and Follow-up visit
Psychiatric symptom questionnaires- Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidality will be assessed by C-SSRS.
Measured: Screening (Up to 30 days prior to Day 1), Day 1 (pre-dose and approximately 4 hours post dose), Day 2 (prior to discharge), Day 5 (prior to discharge), in each treatment period and Follow-up visit
Psychiatric symptom questionnaires- Bond and Lader Visual Analogue Scales (VAS).
Mood anxiety and suicidality will be assessed by VAS.
Measured: Screening (Up to 30 days prior to Day 1), Day 1 (pre-dose and approximately 4 hours post dose), Day 2 (prior to discharge), Day 3 (prior to discharge), Day 4 (prior to discharge), Day 5 (prior to discharge), in each treatment period and Follow-up visit
Computerized tests of reaction time (CANTAB)
CANTAB attention tasks comprising of Simple Reaction Time (SRT), Choice Reaction Time (CRT) and Rapid Visual Information Processing (RVP) will be done to measure the power of attention
Measured: Approximately 1 hour pre-dose on Day 1 and approximately 4 hours post dose on Day 1, Day 2 and Day 5 in each treatment period

Secondary outcomes (6)

Plasma cortisol concentrations
Plasma cortisol concentrations will be measured under fasting conditions to test that the OPRM1 A118G polymorphism modulates the effect of GSK1521498 10mg on plasma cortisol
Measured: Day 1 and Day 5 pre-dose, at approximately the same time, and on Day 5 post dose in each treatment period.
Pressure pain threshold and sensitivity
Pressure pain threshold and sensitivity will be measured in response to cutaneous pressure. Pressure pain thresholds and tolerance will be assessed at two tender points (left and right trapezius points, as defined by American College of Rheumatology)
Measured: Day 4 in each treatment period.
Consummatory eating behaviour
Eating behaviour will be assessed by ad libitum snacking , Menu choices and ad libitum intake of test buffet meals, Appetite Visual Analogue Scales (A-VAS) and Binge Eating Scale (BES)
Measured: Day 5 in each treatment period.
Hedonic taste preference
Response to sweet and high fat samples (tasting sweetened dairy products), will be performed in a fasted state. The Hedonic 9 point preference scale and Sensory Stimuli Scale will be performed after each sample has been tasted.
Measured: Day 5 in each treatment period.
Subjective responses to intravenous doses of ethanol
It will be measured using self-report questionnaires Biphasic alcohol effects scale (BAES), Subjective High Assessment Scale (SHAS), Profile of Mood States (POMS-B), and Alcohol Rating Scale (ARS)
Measured: Day 4 in each treatment period
To compare the placebo-controlled effects of GSK1521498 10 mg to the placebo-controlled effects of NTX 50 mg
The comparison will be done for the all efficacy endpoints as mentioned earlier which include Plasma cortisol; fMRI and cognitive measures of reward processing; pain threshold; hedonic and consummatory eating behaviour, subjective response to ethanol
Measured: Day 5 in each treatment period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 201227 May 2014

First posted30 Nov 2012 (estimated)
Study start12 Dec 2012
Primary completion27 May 2014
Study completion27 May 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AlcoholismStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01738867
Sponsor's protocol ID: 116753
Status last verified: May 2017
First submitted: 28 Nov 2012
Last updated: 10 May 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Influence of the A118G Polymorphism in the mu Opioid Receptor Gene (OPRM1) on Effects of GSK1521498 and Naltrexone on Physiological and Behavioural Markers of Brain Function in Healthy Social Drinkers
ClinicalTrials.gov ID: NCT01738867
Acronym / sponsor ID: 116753
Conditions: Alcoholism
Keywords: Pharmacogenetics, OPRM1, Pharmacodynamics, Addiction, mu opioid receptors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 12 Dec 2012 (actual)
Primary completion: 27 May 2014 (actual)
Study completion: 27 May 2014 (actual)
First posted: 30 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Treatment A	Placebo comparator	Drug: PlaceboSubject will receive oral dose of matching placebo once daily for 5 days in one of the 3 treatment periods.
Treatment B	Experimental	Drug: Naltrexone (NTX)Subject will receive 25 mg orally once daily for the first two days and 50 mg once daily for 3 days in one of the 3 treatment periods.
Treatment C	Experimental	Drug: GSK1521498Subject will receive 10 mg orally once daily for 5 days in one of the 3 treatment periods.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Caucasian male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent
BMI in the normal range or greater, which is equal to 22 kilogram (kg) per meter square (m^2) or above, but otherwise healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Self reported alcohol drinking frequency of 3 or more drinks for men (2 or more drinks for women) at least two days per week, on average or a score of 6 or higher on the Alcohol-Use-Disorders-Identification Test (AUDIT).
Aspartate aminotransferase (AST) and alanine transaminase (ALT) <2xUpper Limit of Normal (ULN); alkaline phosphatase and bilirubin <=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
A female subject is eligible to participate if she is of child-bearing potential and is abstinent or agrees to use one of the accepted contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 14 days after receiving the last dose of study medication.

Key exclusion criteria (21 listed)

Psychiatric illness and substance abuse:
Current or past history of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) alcohol or substance dependence or abuse, including treatment-seeking behaviour, as determined by the Investigator or Mini-international neuropsychiatric interview (MINI).
Self administered Beck Depression Inventory II scale total score greater than 13 or suicide question score greater than zero at screening.
Current or past chronic history of neurological disorders.
Current or past history of Axis 1 psychiatric disorders including eating disorders such as anorexia nervosa, bulimia nervosa and binge eating disorder, including treatment seeking behaviour using the MINI.

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
GSK1521498White HPMC capsule containing 10 mg of GSK1521498	Drug	Treatment C
Naltrexone (NTX)Swedish orange gelatin capsule containing 25mg of NTX or 50mg of NTX	Drug	Treatment B
PlaceboMatching placebo capsules to GSK1521498 or NTX	Drug	Treatment A

Primary outcome

Brain activation within the reward circuitry in response to consumption of food and alcohol cues, as measured by functional magnetic resonance imaging (fMRI)
Time frame: Day 5 in each treatment period
To test that the OPRM1 A118G polymorphism modulates the effects of GSK1521498 10 mg on brain reward function and processing
Adverse events as a measure of safety and tolerability
Time frame: Throughout the study, from Day 1 to Day 67
Number of subjects with any adverse events during the treatment periods
Blood pressure (BP) as a measure of safety and tolerability
Time frame: Screening (Up to 30 days prior to Day 1), Day 1, Day 2, Day 5 in each treatment period and Follow-up visit.
Systolic and diastolic BP will be measured
12-lead ECG and heart rate as a measure of safety and tolerability
Time frame: Screening (Up to 30 days prior to Day 1), Day 1, Day 2, Day 5 in each treatment period and Follow-up visit.
12-lead electrocardiograph (ECG) will be measured
Clinical chemistry including liver enzymes and hematology as a measure of safety and tolerability
Time frame: Screening (Up to 30 days prior to Day 1), Day 5 of each of the 3 treatment periods and Follow-up visit
Hematology/Chemistry assessments to be done at screening (fasted) and day 5 for each treatment session (un-fasted).
Psychiatric symptom questionnaires-Becks Depression & Anxiety Inventory (BDI-II & BAI)
Time frame: Screening (Up to 30 days prior to Day 1), Day 1 (pre-dose and approximately 4 hours post dose), Day 2 (prior to discharge), Day 3 (prior to discharge), Day 5 (prior to discharge), in each treatment period and Follow-up visit
Mood anxiety will be assessed by The Beck Anxiety Inventory (BAI), The Beck Depression Inventory (BDI-II).
Psychiatric symptom questionnaires- Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Screening (Up to 30 days prior to Day 1), Day 1 (pre-dose and approximately 4 hours post dose), Day 2 (prior to discharge), Day 5 (prior to discharge), in each treatment period and Follow-up visit
Suicidality will be assessed by C-SSRS.
Psychiatric symptom questionnaires- Bond and Lader Visual Analogue Scales (VAS).
Time frame: Screening (Up to 30 days prior to Day 1), Day 1 (pre-dose and approximately 4 hours post dose), Day 2 (prior to discharge), Day 3 (prior to discharge), Day 4 (prior to discharge), Day 5 (prior to discharge), in each treatment period and Follow-up visit
Mood anxiety and suicidality will be assessed by VAS.
Computerized tests of reaction time (CANTAB)
Time frame: Approximately 1 hour pre-dose on Day 1 and approximately 4 hours post dose on Day 1, Day 2 and Day 5 in each treatment period
CANTAB attention tasks comprising of Simple Reaction Time (SRT), Choice Reaction Time (CRT) and Rapid Visual Information Processing (RVP) will be done to measure the power of attention

6 secondary outcomes

Plasma cortisol concentrations
Time frame: Day 1 and Day 5 pre-dose, at approximately the same time, and on Day 5 post dose in each treatment period.
Pressure pain threshold and sensitivity
Time frame: Day 4 in each treatment period.
Consummatory eating behaviour
Time frame: Day 5 in each treatment period.
Hedonic taste preference
Time frame: Day 5 in each treatment period.
Subjective responses to intravenous doses of ethanol
Time frame: Day 4 in each treatment period
To compare the placebo-controlled effects of GSK1521498 10 mg to the placebo-controlled effects of NTX 50 mg
Time frame: Day 5 in each treatment period.

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 10 May 2017.
Results for study 116753 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1521498 and Naltrexone (NTX) in people with Alcoholism, run by GlaxoSmithKline at 1 site in United Kingdom.

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 7 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 10 May 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 Kingdom. 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 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.

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?

Brain activation within the reward circuitry in response to consumption of food and alcohol cues, as measured by functional magnetic resonance imaging (fMRI) (time frame: Day 5 in each treatment period). The study lists 9 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 NCT01738867.

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 10 May 2017.