Binge-Eating DisorderNCT04077502
Repetitive Transcranial Magnetic Stimulation in Treatment of Binge Eating Disorder
A study testing Repetitive Transcranial Magnetic Stimulation in people with Binge-Eating Disorder, run by Charles University, Czech Republic.
Trial summary
Hypothesis: High-frequency rTMS can significantly reduce craving for food in patients with BED just after the stimulation and also over the one month observation period. Method: The study was designed as a randomized double blind and placebo controlled one. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 2014to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having binge eating disorder
- being over the age of 18
Who cannot join
- contraindications for rTMS such as: a history of epileptic seizur paroxysms, increased intracranial pressure, brain tumor, implanted metal devices in the cranium (except the oral cavity), and any implanted peacemaker or drug pump
- non-compliance - inability to complet 10 sessions of stimulation
About this study
Official title: Repetitive Transcranial Magnetic Stimulation in Treatment of Binge Eating Disorder. A Double Blind Placebo Controlled Study
Hypothesis: High-frequency rTMS can significantly reduce craving for food in patients with BED just after the stimulation and also over the one month observation period.
Method: The study was designed as a randomized double blind and placebo controlled one. The active group was stimulated by high-frequency rTMS, with the following stimulation parameters: frequency 10 Hz, 1500 pulses, 107 s inter-train, 100% minimal motor threshold and 10 stimulation session. The control group was stimulated by a sham rTMS coil. The FCQ-S and the FCQ-T questionnaires were used to evaluate the food craving.
Read the detailed description
The study was realized at Department of Psychiatry First Faculty of Medicine Charles University in Prague and General University Hospital in Prague during 2013 - 2018. The study was approved by the Ethics committee General University Hospital in Prague by a decision dated 23.1.2014, number 1867/13 S-IV (individual research). The study was registered on clinicaltrials.gov.
Two psychiatrists examined each patient who signed up for the study, in order to set the diagnoses. The DSM-5 diagnostic criteria were used for the purpose of the study. The exclusion criteria were mainly based upon contraindications for rTMS such as: a history of epileptic seizure paroxysms, increased intracranial pressure, brain tumor, implanted metal devices in the cranium (except the oral cavity), and any implanted peacemaker or drug pump. Also, patients who were not able to complete 10 sessions of rTMS were excluded for non-compliance. Inclusion criteria were: having BED and being over the age of 18. The study did not account for the hemispherical laterality.
After signing an informed consent form, subjects were included into the study and randomly divided into two groups: one group stimulated by a real rTMS coil (group A - active), and the second (control group), stimulated by a sham rTMS coil (group P - placebo).
Patients were also offered to participate in cognitive behavioral group therapy (CBT) simultaneously with the rTMS treatment. However, the attendance in the CBT was voluntary, and it was not a condition for inclusion into the study.
The study was conceived as randomized double blind placebo controlled clinical study. The randomization was performed by statistics independent of study. The investigators group achieved the study´s double blind characteristics by dividing the roles of the researchers. One author provided the examinations of the patients, CBT, data collection and evaluations of the questionnaires, while a second author administered the stimulations. The control group was "blind" thanks to the use of the sham coil.
Collection of data and statistical analysis Subjects were asked to fill out the set of questionnaires consisting of the EDE-Q (Eating Disorder Examination - Questionnaire), as well as the FCQ-S, and the FCQ-T before the first stimulation session. The EDE-Q served to collect demographfic data, and to evaluate the severity of the disorder. On the day of the last stimulation, and one month after the last stimulation, subjects filled out the FCQ-S and the FCQ-T again.
Statistical package R, version 3.4.2 was used for the statistical processing of the data. The two-sample t-test method was used to compare the differences in cravings between subjects stimulated by the real and sham coils in all situations: before stimulation, directly after the last stimulation, and one month after the last stimulation. The paired t-test method was used to evaluate the changes of craving over time, meaning the difference in craving before the stimulation and on the last day of stimulation, and difference in craving on the last day of stimulation and one month after the last stimulation.
Parameters of stimulation A MAGSTIM Super Rapid 2 device with eight flat shaped coil was used to provide the rTMS. The control group was stimulated by a sham coil with similar side effects regarding sound and a pain perception on the scalp. The left DLPFC was chosen as the stimulation target. The coil placement for the DLPFC stimulation was 5 cm anterior in the same parasagital line from the place of maximum musculus abductor pollicis brevis response. The stimulation site was outlined on a cap, which was repositioned during each rTMS session.
The number of sessions was set on 10. Each stimulation session consisted of 15 trains of 10 s and 107 s intertrain, at a frequency of 10 Hz. That meant 1500 pulses applied during one session taking cca 20 minutes. The intensity of stimulation was 100% of minimal motor threshold (MMT). MMT was identified as the minimum magnetic field strength required to produce a motoric response of right thenar muscle, which was determined by visual control and controlled by EMG measurement. Stimulations were realized throughout a two week period, excepting weekends.
- Conditions
- Binge-Eating Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- binge eating disorder, craving, repetitive transcranial magnetic stimulation
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Repetitive Transcranial Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| stimulated group | Active comparator | The group stimulated by real coil of rTMS. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| controle group | Sham comparator | The group stimulated by sham coil of rTMS. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of craving
For evaluation of craving the Food Craving Questionnaire-State (FCQ-S) was used. The degree of craving was rated from "never" (0 points), through "rarely", "sometimes", "often", "usually", to "always" (5 points). The FCQ-State (FCQ-S) consisted of 15 questions, which are focused on the craving being dependent on the actual psychological conditions of the subject. The degree of craving can range from 0 to 65 points.
Measured: one month
The degree of craving
For evaluation of craving the Food Craving Questionnaire-Trait (FCQ-t) was used. The degree of craving was rated from "never" (0 points), through "rarely", "sometimes", "often", "usually", to "always" (5 points). The FCQ-Trait (FCQ-T) consisted of 39 questions focused on the craving as a stable property over time. The degree of craving can range from 0 to 195 points.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start23 Jan 2014
- Primary completionAug 2018
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double blinde and placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarína Jaššová, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077502
- Sponsor's protocol ID
- CharlesUniversityPragueCR
- Status last verified
- Sep 2019
- First submitted
- 7 Aug 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baczynski TP, de Aquino Chaim CH, Nazar BP, Carta MG, Arias-Carrion O, Silva AC, Machado S, Nardi AE. High-frequency rTMS to treat refractory binge eating disorder and comorbid depression: a case report. CNS Neurol Disord Drug Targets. 2014;13(5):771-5. doi: 10.2174/1871527313666140307154823.
PubMed 24606720Nijs IM, Franken IH, Muris P. The modified Trait and State Food-Cravings Questionnaires: development and validation of a general index of food craving. Appetite. 2007 Jul;49(1):38-46. doi: 10.1016/j.appet.2006.11.001. Epub 2006 Dec 21.
PubMed 17187897Cepeda-Benito A, Gleaves DH, Fernandez MC, Vila J, Williams TL, Reynoso J. The development and validation of Spanish versions of the State and Trait Food Cravings Questionnaires. Behav Res Ther. 2000 Nov;38(11):1125-38. doi: 10.1016/s0005-7967(99)00141-2.
PubMed 11060941Downar J, Sankar A, Giacobbe P, Woodside B, Colton P. Unanticipated Rapid Remission of Refractory Bulimia Nervosa, during High-Dose Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex: A Case Report. Front Psychiatry. 2012 Apr 20;3:30. doi: 10.3389/fpsyt.2012.00030. eCollection 2012.
PubMed 22529822Gay A, Jaussent I, Sigaud T, Billard S, Attal J, Seneque M, Galusca B, Van Den Eynde F, Massoubre C, Courtet P, Guillaume S. A Lack of Clinical Effect of High-frequency rTMS to Dorsolateral Prefrontal Cortex on Bulimic Symptoms: A Randomised, Double-blind Trial. Eur Eat Disord Rev. 2016 Nov;24(6):474-481. doi: 10.1002/erv.2475. Epub 2016 Sep 15.
PubMed 27633286McClelland J, Bozhilova N, Nestler S, Campbell IC, Jacob S, Johnson-Sabine E, Schmidt U. Improvements in symptoms following neuronavigated repetitive transcranial magnetic stimulation (rTMS) in severe and enduring anorexia nervosa: findings from two case studies. Eur Eat Disord Rev. 2013 Nov;21(6):500-6. doi: 10.1002/erv.2266.
PubMed 24155247McClelland J, Kekic M, Bozhilova N, Nestler S, Dew T, Van den Eynde F, David AS, Rubia K, Campbell IC, Schmidt U. A Randomised Controlled Trial of Neuronavigated Repetitive Transcranial Magnetic Stimulation (rTMS) in Anorexia Nervosa. PLoS One. 2016 Mar 23;11(3):e0148606. doi: 10.1371/journal.pone.0148606. eCollection 2016.
PubMed 27008620Uher R, Yoganathan D, Mogg A, Eranti SV, Treasure J, Campbell IC, McLoughlin DM, Schmidt U. Effect of left prefrontal repetitive transcranial magnetic stimulation on food craving. Biol Psychiatry. 2005 Nov 15;58(10):840-2. doi: 10.1016/j.biopsych.2005.05.043. Epub 2005 Aug 8.
PubMed 16084855Van den Eynde F, Claudino AM, Mogg A, Horrell L, Stahl D, Ribeiro W, Uher R, Campbell I, Schmidt U. Repetitive transcranial magnetic stimulation reduces cue-induced food craving in bulimic disorders. Biol Psychiatry. 2010 Apr 15;67(8):793-5. doi: 10.1016/j.biopsych.2009.11.023. Epub 2010 Jan 8.
PubMed 20060105Jassova K, Albrecht J, Papezova H, Anders M. Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Depression and Anxiety in a Patient with Anorexia Nervosa. Med Sci Monit. 2018 Jul 30;24:5279-5281. doi: 10.12659/MSM.908250.
PubMed 30057403
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation in Treatment of Binge Eating Disorder. A Double Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04077502
- Acronym / sponsor ID
- CharlesUniversityPragueCR
- Conditions
- Binge-Eating Disorder
- Keywords
- binge eating disorder, craving, repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 23 Jan 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 4 Sep 2019 (actual)
- 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.
Hypothesis: High-frequency rTMS can significantly reduce craving for food in patients with BED just after the stimulation and also over the one month observation period.
Method: The study was designed as a randomized double blind and placebo controlled one. The active group was stimulated by high-frequency rTMS, with the following stimulation parameters: frequency 10 Hz, 1500 pulses, 107 s inter-train, 100% minimal motor threshold and 10 stimulation session. The control group was stimulated by a sham rTMS coil. The FCQ-S and the FCQ-T questionnaires were used to evaluate the food craving.
Detailed description
The study was realized at Department of Psychiatry First Faculty of Medicine Charles University in Prague and General University Hospital in Prague during 2013 - 2018. The study was approved by the Ethics committee General University Hospital in Prague by a decision dated 23.1.2014, number 1867/13 S-IV (individual research). The study was registered on clinicaltrials.gov.
Two psychiatrists examined each patient who signed up for the study, in order to set the diagnoses. The DSM-5 diagnostic criteria were used for the purpose of the study. The exclusion criteria were mainly based upon contraindications for rTMS such as: a history of epileptic seizure paroxysms, increased intracranial pressure, brain tumor, implanted metal devices in the cranium (except the oral cavity), and any implanted peacemaker or drug pump. Also, patients who were not able to complete 10 sessions of rTMS were excluded for non-compliance. Inclusion criteria were: having BED and being over the age of 18. The study did not account for the hemispherical laterality.
After signing an informed consent form, subjects were included into the study and randomly divided into two groups: one group stimulated by a real rTMS coil (group A - active), and the second (control group), stimulated by a sham rTMS coil (group P - placebo).
Patients were also offered to participate in cognitive behavioral group therapy (CBT) simultaneously with the rTMS treatment. However, the attendance in the CBT was voluntary, and it was not a condition for inclusion into the study.
The study was conceived as randomized double blind placebo controlled clinical study. The randomization was performed by statistics independent of study. The investigators group achieved the study´s double blind characteristics by dividing the roles of the researchers. One author provided the examinations of the patients, CBT, data collection and evaluations of the questionnaires, while a second author administered the stimulations. The control group was "blind" thanks to the use of the sham coil.
Collection of data and statistical analysis Subjects were asked to fill out the set of questionnaires consisting of the EDE-Q (Eating Disorder Examination - Questionnaire), as well as the FCQ-S, and the FCQ-T before the first stimulation session. The EDE-Q served to collect demographfic data, and to evaluate the severity of the disorder. On the day of the last stimulation, and one month after the last stimulation, subjects filled out the FCQ-S and the FCQ-T again.
Statistical package R, version 3.4.2 was used for the statistical processing of the data. The two-sample t-test method was used to compare the differences in cravings between subjects stimulated by the real and sham coils in all situations: before stimulation, directly after the last stimulation, and one month after the last stimulation. The paired t-test method was used to evaluate the changes of craving over time, meaning the difference in craving before the stimulation and on the last day of stimulation, and difference in craving on the last day of stimulation and one month after the last stimulation.
Parameters of stimulation A MAGSTIM Super Rapid 2 device with eight flat shaped coil was used to provide the rTMS. The control group was stimulated by a sham coil with similar side effects regarding sound and a pain perception on the scalp. The left DLPFC was chosen as the stimulation target. The coil placement for the DLPFC stimulation was 5 cm anterior in the same parasagital line from the place of maximum musculus abductor pollicis brevis response. The stimulation site was outlined on a cap, which was repositioned during each rTMS session.
The number of sessions was set on 10. Each stimulation session consisted of 15 trains of 10 s and 107 s intertrain, at a frequency of 10 Hz. That meant 1500 pulses applied during one session taking cca 20 minutes. The intensity of stimulation was 100% of minimal motor threshold (MMT). MMT was identified as the minimum magnetic field strength required to produce a motoric response of right thenar muscle, which was determined by visual control and controlled by EMG measurement. Stimulations were realized throughout a two week period, excepting weekends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blinde and placebo controlled
| Arm | Type | Receives |
|---|---|---|
| stimulated group | Active comparator | Device: Repetitive Transcranial Magnetic StimulationThe group stimulated by real coil of rTMS. |
| controle group | Sham comparator | Device: Repetitive Transcranial Magnetic StimulationThe group stimulated by sham coil of rTMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- having binge eating disorder
- being over the age of 18
Key exclusion criteria (2 listed)
- contraindications for rTMS such as: a history of epileptic seizur paroxysms, increased intracranial pressure, brain tumor, implanted metal devices in the cranium (except the oral cavity), and any implanted peacemaker or drug pump
- non-compliance - inability to complet 10 sessions of stimulation
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationRepetitive Transcranial Magnetic Stimulation | Device | controle group, stimulated group |
Primary outcome
The degree of craving
Time frame: one month
For evaluation of craving the Food Craving Questionnaire-State (FCQ-S) was used. The degree of craving was rated from "never" (0 points), through "rarely", "sometimes", "often", "usually", to "always" (5 points). The FCQ-State (FCQ-S) consisted of 15 questions, which are focused on the craving being dependent on the actual psychological conditions of the subject. The degree of craving can range from 0 to 65 points.
The degree of craving
Time frame: one month
For evaluation of craving the Food Craving Questionnaire-Trait (FCQ-t) was used. The degree of craving was rated from "never" (0 points), through "rarely", "sometimes", "often", "usually", to "always" (5 points). The FCQ-Trait (FCQ-T) consisted of 39 questions focused on the craving as a stable property over time. The degree of craving can range from 0 to 195 points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Background: PubMed 24606720Baczynski TP, de Aquino Chaim CH, Nazar BP, Carta MG, Arias-Carrion O, Silva AC, Machado S, Nardi AE. High-frequency rTMS to treat refractory binge eating disorder and comorbid depression: a case report. CNS Neurol Disord Drug Targets. 2014;13(5):771-5. doi: 10.2174/1871527313666140307154823.
- Background: PubMed 17187897Nijs IM, Franken IH, Muris P. The modified Trait and State Food-Cravings Questionnaires: development and validation of a general index of food craving. Appetite. 2007 Jul;49(1):38-46. doi: 10.1016/j.appet.2006.11.001. Epub 2006 Dec 21.
- Background: PubMed 11060941Cepeda-Benito A, Gleaves DH, Fernandez MC, Vila J, Williams TL, Reynoso J. The development and validation of Spanish versions of the State and Trait Food Cravings Questionnaires. Behav Res Ther. 2000 Nov;38(11):1125-38. doi: 10.1016/s0005-7967(99)00141-2.
- Background: PubMed 22529822Downar J, Sankar A, Giacobbe P, Woodside B, Colton P. Unanticipated Rapid Remission of Refractory Bulimia Nervosa, during High-Dose Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex: A Case Report. Front Psychiatry. 2012 Apr 20;3:30. doi: 10.3389/fpsyt.2012.00030. eCollection 2012.
- Background: PubMed 27633286Gay A, Jaussent I, Sigaud T, Billard S, Attal J, Seneque M, Galusca B, Van Den Eynde F, Massoubre C, Courtet P, Guillaume S. A Lack of Clinical Effect of High-frequency rTMS to Dorsolateral Prefrontal Cortex on Bulimic Symptoms: A Randomised, Double-blind Trial. Eur Eat Disord Rev. 2016 Nov;24(6):474-481. doi: 10.1002/erv.2475. Epub 2016 Sep 15.
- Background: PubMed 24155247McClelland J, Bozhilova N, Nestler S, Campbell IC, Jacob S, Johnson-Sabine E, Schmidt U. Improvements in symptoms following neuronavigated repetitive transcranial magnetic stimulation (rTMS) in severe and enduring anorexia nervosa: findings from two case studies. Eur Eat Disord Rev. 2013 Nov;21(6):500-6. doi: 10.1002/erv.2266.
- Background: PubMed 27008620McClelland J, Kekic M, Bozhilova N, Nestler S, Dew T, Van den Eynde F, David AS, Rubia K, Campbell IC, Schmidt U. A Randomised Controlled Trial of Neuronavigated Repetitive Transcranial Magnetic Stimulation (rTMS) in Anorexia Nervosa. PLoS One. 2016 Mar 23;11(3):e0148606. doi: 10.1371/journal.pone.0148606. eCollection 2016.
- Background: PubMed 16084855Uher R, Yoganathan D, Mogg A, Eranti SV, Treasure J, Campbell IC, McLoughlin DM, Schmidt U. Effect of left prefrontal repetitive transcranial magnetic stimulation on food craving. Biol Psychiatry. 2005 Nov 15;58(10):840-2. doi: 10.1016/j.biopsych.2005.05.043. Epub 2005 Aug 8.
- Background: PubMed 20060105Van den Eynde F, Claudino AM, Mogg A, Horrell L, Stahl D, Ribeiro W, Uher R, Campbell I, Schmidt U. Repetitive transcranial magnetic stimulation reduces cue-induced food craving in bulimic disorders. Biol Psychiatry. 2010 Apr 15;67(8):793-5. doi: 10.1016/j.biopsych.2009.11.023. Epub 2010 Jan 8.
- Results publication: PubMed 30057403Jassova K, Albrecht J, Papezova H, Anders M. Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Depression and Anxiety in a Patient with Anorexia Nervosa. Med Sci Monit. 2018 Jul 30;24:5279-5281. doi: 10.12659/MSM.908250.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Binge-Eating Disorder, run by Charles University, Czech Republic.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
The degree of craving (time frame: one month). The study lists 2 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 NCT04077502, which also lists 10 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 4 Sep 2019.