Behavioural AddictionPhase 3NABAbNCT05540288
NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions
A Phase 3 study testing Nalmefene in people with Behavioural Addiction, run by Nantes University Hospital at 13 sites in France.
Trial summary
Behavioural addictions (BAs) [gambling disorder (GD), food addiction (FA), sexual addiction (SA)] may lead to disastrous consequences. They are often associated with other addictive or psychiatric disorders, and high rates of suicide attempts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavioural Addiction
- What is being tested?
- Nalmefene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 13 sitesFrance
- Study dates
- 31 Mar 2023to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having presented at least one episode of craving with an intensity ≥ 4/10 at the NRS during the week prior to inclusion
- Women must meet one of the following criteria at the time of inclusion:
- use adequate contraceptive measures as recommended by the CTFG (Recommendations related to contraception and pregnancy testing in clinical trials v1.1), and have a negative pregnancy test (urine test) prior to receiving the first dose of study drug;
- or be post-menopausal (over 50 years of age with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal therapy)
- or (if under 50 years of age) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal therapy and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels
- or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented).
Who cannot join
- Being currently treated by another anti-craving drug that have been already tested for craving reduction in BAs (naltrexone, acamprosate, baclofène, topiramate, bupropion, N-acetyl-cystéine, disulfiram, etc.);
- Presenting a contraindication for the use of nalmefene (listed in the SmPC):
- Known hypersensitivity to the active substance or to any of the excipients. In particular, intolerance to galactose or deficiency in Lapp lactase or glucose-galactose malabsorption (rare hereditary diseases);
- Treatment by opioid agonists (full or partial) (opioid pain relievers, opioid substitution drugs);
- Recent history of opioid dependence or current opioid dependence;
- Current symptoms of the acute opioid withdrawal syndrome;
Show all 22Show fewer
- Suspected recent consumption of opioid (necessity to consider the half-life);
- Severe hepatic impairment (Child-Pugh stage B or C);
- Severe renal impairment (estimated glomerular filtration rate [TFGe] <30 mL/min/1.73 m2);
- History of recent acute alcohol withdrawal syndrome (including hallucinations, convulsions and delirium tremens).
- Predictable opioid treatment during the study period;
- Unstable psychiatric disorders (meaning disorders for which the treatment was modified since less than a month (corresponding to the instauration of a new treatment, or the increase in dosage of a treatment already being taken)), including severe risk of suicide (i.e. necessity to engage specific medication or hospitalization; psychotropic medication engaged since less than 1 month; absence of improvement after one month of medication) (because nalmefene has not been studied in patients with unstable psychiatric disorders). Patients with a food addiction diagnosed with eating disorders marked by the presence of binge eating can be included;
- Anorexia nervosa-restricting type (because food addiction concept is poorly established among patients with AN-R, who do not have binge eating episodes induced by craving);
- Extreme leanness (body mass index < 16.5) (because loss of appetite and/or weight loss are frequent adverse effects of nalmefene);
- Current treatment with potent inhibitor drugs of the UGT2B7 (UDP-Glucuronosyltransferase-2B7); for example: diclofenac, fluconazole, medroxyprogesterone acetate, meclofenamic acid;
- Current treatment with UGT inducing drugs; for example: dexamethasone, phenobarbital, rifampicin, omeprazole;
- Inability to indicate the time of day of the most intense craving episode (because this information will determine the time of day the treatment should be taken);
- Pregnancy (attested by a pregnancy urinary test for women of childbearing age) or breastfeeding woman;
- Trusteeship;
- Major cognitive impairment;
- Not fluent in French;
- Participation to another interventional study during the last month or expected participation to another interventional study during participation to the NABAB study.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites, 13 recruiting
- Not yet recruiting
CHU de Besançon
Besançon
Julie GIUSTINIANI, jgiustiniani@chu-besancon.fr
Julie GIUSTINIANI, Dr
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Mélina FATSEAS-LOPEZ, melina.fatseas@chu-bordeaux.fr
Mélina FATSEAS-LOPEZ
- Recruiting
CHRU de Brest
Brest, 29200
Morgane GUILLOU-LANDREAT, morgane.guillou@chu-brest.fr
Morgane GUILLOU-LANDREAT
- Recruiting
CHU de Clermont Ferrand
Clermont-Ferrand, 63000
Georges BROUSSE, gbrousse@chu-clermontferrand.fr
Georges BROUSSE
- Not yet recruiting
CHU de Dijon
Dijon, 21000
Benoit TROJAK, Pr, +333.80.29.37.69, benoit.trojak@chu-dijon.fr
Benoit TROJAK, Pr
- Recruiting
CH de La Rochelle
La Rochelle, 17000
Patrick BENDIMERAD, patrick.bendimerad@ght-atlantique17.fr
Patrick BENDIMERAD
- Recruiting
Hospices Civils de Lyon
Lyon, 69000
Véronique FONTEILLE, veronique.fonteille@chu-lyon.fr
Véronique FONTEILLE
- Not yet recruiting
CHU de Montpellier
Montpellier, 34295
Hélène DONNADIEU, Pr, +334.67.33.70.20, h-donnadieu@chu-montpellier.fr
Hélène DONNADIEU, Pr
- Recruiting
CHU de Nantes
Nantes
Marie GRALL-BRONNEC, marie.bronnec@chu-nantes.fr
Marie GRALL-BRONNEC
- Recruiting
CHU de Nîmes
Nîmes, 30000
Amandine LUQUIENS, amandineluquiens@gmail.com
Amandine LUQUIENS
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Louis-Marie D'USSEL, louis-marie.dussel@chru-strasbourg.fr
Louis-Marie D'USSEL
- Recruiting
CHRU de Tours
Tours, 37000
Paul BRUNAULT, paul.brunault@univ-tours.fr
Paul BRUNAULT
- Recruiting
Hôpital Paul Brousse
Villejuif, 94800
Amine BENYAMINA, amine.benyamina@aphp.fr
Amine BENYAMINA
About this study
Behavioural addictions (BAs) [gambling disorder (GD), food addiction (FA), sexual addiction (SA)] may lead to disastrous consequences. They are often associated with other addictive or psychiatric disorders, and high rates of suicide attempts. Epidemiological studies report prevalence reaching 2.7% for GD, 5% for SA, and up to 7.9% for FA.
Many similarities have been highlighted between BAs, as well as with substance use disorders. One core clinical similarity between those disorders is craving (uncontrollable urge to engage in rewarding behaviours), which has been consistently associated with diminished control over the behaviour and relapse.
Read more
At present, no pharmacological treatment has been approved for BAs, but several medications have been tested. Among them, two opioid receptor antagonists - naltrexone and nalmefene - appear the most promising. By decreasing dopamine neurotransmission in the reward circuitry, they reduce both excitement for rewarding behaviours and craving.
Compared to naltrexone, nalmefene seems to have a better safety. To date, no study investigated the efficacy of nalmefene as a pan-addiction treatment for BAs. Two clinical trials have demonstrated its efficacy for the treatment of GD, but no clinical trial was conducted for FA and SA.
The investigators hypothesise that nalmefene (36 mg/d), compared to a placebo, can have a therapeutic effect as an add-on to usual treatment for decreasing craving in several BAs.
- Conditions
- Behavioural Addiction
- Being tested
- Nalmefene, Placebo
- Keywords
- Nalmefene, Craving, Behavioural addiction, Gambling disorder, Food addiction, Sexual addiction
- Medical subject headings
- Gambling, Food Addiction, Compulsive Sexual Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalmefeneDrug
Week 1: 18 mg/d
Week 2:
- In the absence of ARs or in the presence of grade 1 or 2 ARs, 36 mg/d
- In the presence of grade 3 ARs, 18 mg/d
- In the presence of grade 4 ARs, treatment will be stopped immediately.
Week 3 to week 5:
- In case of acceptable safety profile at the 18mg/d dosage during week 2, the treatment will be maintained at the same dosage
- In the presence of sustained grade 3 ARs at the 18mg/d dosage during week 2, the treatment will be stopped.
- In case of acceptable safety profile at the 36mg/d dosage during week 2, the treatment will be maintained at the same dosage
- In the presence of grade 3 ARs at the 36mg/d dosage during week 2, the treatment dosage will be decreased at 18mg/d
- Whatever the dosage during week 2, in the presence of grade 4 ARs, the treatment will be stopped immediately.
PlaceboDrug
Week 1: 1 tablet/d
Week 2:
- In the absence of ARs or in the presence of grade 1 or 2 ARs, 2 tablets/d
- In the presence of grade 3 ARs, 1 tablet/d
- In the presence of grade 4 ARs, the treatment will be stopped immediately.
Week 3 to week 5:
- In case of acceptable safety profile at the dosage of 1 tablet/d during week 2, the treatment will be maintained at the same dosage
- In the presence of sustained grade 3 ARs at the dosage of 1 tablet/d during week 2, the treatment will be stopped.
- In case of acceptable safety profile at the dosage of 2 tablets/d during week 2, the treatment will be maintained at the same dosage
- In the presence of grade 3 ARs at the dosage of 2 tablets/d during week 2, the treatment dosage will be decreased at 1 tablet/d
- Whatever the dosage during week 2, in the presence of grade 4 ARs, the treatment will be stopped immediately.
| Study group | Role | What they receive |
|---|---|---|
| Nalmefene | Experimental | Not described Receives: Drug: Nalmefene |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of averaged intensity of craving episodes between start and end of treatment.
Variation of averaged intensity of craving episodes between start (during the week preceding initiation of treatment) and end (during the week preceding end of treatment) of treatment. Each craving episode will be reported by the patient on a weekly diary, with intensity assessed through a Numerical Rating Scale (NRS) form 0 to 10 (0=lowest intensity and 10= highest intensity).
Measured: 5 weeks
Secondary outcomes (12)
Variation of averaged weekly frequency (number of episodes) of craving episodes between start and end of treatment.
Measured: 5 weeks
Variation of averaged weekly duration (cumulative duration of all episodes) of craving episodes between start and end of treatment.
Measured: 5 weeks
Variation of averaged weekly intensity, frequency and duration of craving episodes between start of treatment and 4 weeks after the end of treatment.
Measured: 9 weeks (5 weeks of treatment +4 weeks of follow up after treatment)
Variation of averaged weekly frequency of the BA episodes: (i) between start and end of treatment and (ii) between start of treatment and 4 weeks after the end of treatment.
Measured: 9 weeks
Variation of averaged weekly duration of the BA episodes: (i) between start and end of treatment and (ii) between start of treatment and 4 weeks after the end of treatment.
Measured: 9 weeks
Variation of averaged weekly intensity of the BA episodes: (i) between start and end of treatment and (ii) between start of treatment and 4 weeks after the end of treatment.
Assessed through a Numerical Rating Scale (NRS) form 0 (lowest intensity) to 10 (highest intensity)
Measured: 9 weeks
Overall clinical improvement, assessed though the Clinical Global Impression - Improvement (CGI-I) scale.
Measured: 9 weeks
Overall clinical improvement, assessed though the GGI - Efficacy Index (CGI-EI).
Measured: 9 weeks
Variation of averaged weekly use of psychoactive substances (including nicotine) and daily life behaviors of interest (gambling, sex, food) between start of treatment and 4 weeks after the end of treatment
Measured: 9 weeks
Number, type and severity of self-reported adverse side effects, during either weeks of treatment at a dosage of 18 mg/d or 36 mg/d.
Measured: 9 weeks
Mutation(s) associated with non-response to nalmefene treatment
Measured: 9 weeks
Sociodemographic, medical and clinical data, especially psychiatric and addictive co-morbidities assessed with the Mini International Neuropsychiatric Interview - Simplified (MINI-S) and the age of the BA
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start31 Mar 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioural AddictionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie GRALL-BRONNEC, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540288
- Sponsor's protocol ID
- RC21_0336
- Acronym
- NABAb
- Status last verified
- Feb 2025
- First submitted
- 6 Sep 2022
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions
- ClinicalTrials.gov ID
- NCT05540288
- Acronym / sponsor ID
- NABAb / RC21_0336
- Conditions
- Behavioural Addiction
- Keywords
- Nalmefene, Craving, Behavioural addiction, Gambling disorder, Food addiction, Sexual addiction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Sep 2022 (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.
Behavioural addictions (BAs) [gambling disorder (GD), food addiction (FA), sexual addiction (SA)] may lead to disastrous consequences. They are often associated with other addictive or psychiatric disorders, and high rates of suicide attempts. Epidemiological studies report prevalence reaching 2.7% for GD, 5% for SA, and up to 7.9% for FA.
Many similarities have been highlighted between BAs, as well as with substance use disorders. One core clinical similarity between those disorders is craving (uncontrollable urge to engage in rewarding behaviours), which has been consistently associated with diminished control over the behaviour and relapse.
At present, no pharmacological treatment has been approved for BAs, but several medications have been tested. Among them, two opioid receptor antagonists - naltrexone and nalmefene - appear the most promising. By decreasing dopamine neurotransmission in the reward circuitry, they reduce both excitement for rewarding behaviours and craving.
Compared to naltrexone, nalmefene seems to have a better safety. To date, no study investigated the efficacy of nalmefene as a pan-addiction treatment for BAs. Two clinical trials have demonstrated its efficacy for the treatment of GD, but no clinical trial was conducted for FA and SA.
The investigators hypothesise that nalmefene (36 mg/d), compared to a placebo, can have a therapeutic effect as an add-on to usual treatment for decreasing craving in several BAs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalmefene | Experimental | Drug: Nalmefene |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having presented at least one episode of craving with an intensity ≥ 4/10 at the NRS during the week prior to inclusion
- use adequate contraceptive measures as recommended by the CTFG (Recommendations related to contraception and pregnancy testing in clinical trials v1.1), and have a negative pregnancy test (urine test) prior to receiving the first dose of study drug;
- or be post-menopausal (over 50 years of age with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal therapy)
- or (if under 50 years of age) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal therapy and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels
- or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented).
Key exclusion criteria (22 listed)
- Being currently treated by another anti-craving drug that have been already tested for craving reduction in BAs (naltrexone, acamprosate, baclofène, topiramate, bupropion, N-acetyl-cystéine, disulfiram, etc.);
- Presenting a contraindication for the use of nalmefene (listed in the SmPC):
- Predictable opioid treatment during the study period;
- Unstable psychiatric disorders (meaning disorders for which the treatment was modified since less than a month (corresponding to the instauration of a new treatment, or the increase in dosage of a treatment already being taken)), including severe risk of suicide (i.e. necessity to engage specific medication or hospitalization; psychotropic medication engaged since less than 1 month; absence of improvement after one month of medication) (because nalmefene has not been studied in patients with unstable psychiatric disorders). Patients with a food addiction diagnosed with eating disorders marked by the presence of binge eating can be included;
- Anorexia nervosa-restricting type (because food addiction concept is poorly established among patients with AN-R, who do not have binge eating episodes induced by craving);
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 |
|---|---|---|
| NalmefeneWeek 1: 18 mg/d Week 2: 1. In the absence of ARs or in the presence of grade 1 or 2 ARs, 36 mg/d 2. In the presence of grade 3 ARs, 18 mg/d 3. In the presence of grade 4 ARs, treatment will be stopped immediately. Week 3 to week 5: 1. In case of acceptable safety profile at the 18mg/d dosage during week 2, the treatment will be maintained at the same dosage 2. In the presence of sustained grade 3 ARs at the 18mg/d dosage during week 2, the treatment will be stopped. 3. In case of acceptable safety profile at the 36mg/d dosage during week 2, the treatment will be maintained at the same dosage 4. In the presence of grade 3 ARs at the 36mg/d dosage during week 2, the treatment dosage will be decreased at 18mg/d 5. Whatever the dosage during week 2, in the presence of grade 4 ARs, the treatment will be stopped immediately. | Drug | Nalmefene |
| PlaceboWeek 1: 1 tablet/d Week 2: 1. In the absence of ARs or in the presence of grade 1 or 2 ARs, 2 tablets/d 2. In the presence of grade 3 ARs, 1 tablet/d 3. In the presence of grade 4 ARs, the treatment will be stopped immediately. Week 3 to week 5: 1. In case of acceptable safety profile at the dosage of 1 tablet/d during week 2, the treatment will be maintained at the same dosage 2. In the presence of sustained grade 3 ARs at the dosage of 1 tablet/d during week 2, the treatment will be stopped. 3. In case of acceptable safety profile at the dosage of 2 tablets/d during week 2, the treatment will be maintained at the same dosage 4. In the presence of grade 3 ARs at the dosage of 2 tablets/d during week 2, the treatment dosage will be decreased at 1 tablet/d 5. Whatever the dosage during week 2, in the presence of grade 4 ARs, the treatment will be stopped immediately. | Drug | Placebo |
Primary outcome
Variation of averaged intensity of craving episodes between start and end of treatment.
Time frame: 5 weeks
Variation of averaged intensity of craving episodes between start (during the week preceding initiation of treatment) and end (during the week preceding end of treatment) of treatment. Each craving episode will be reported by the patient on a weekly diary, with intensity assessed through a Numerical Rating Scale (NRS) form 0 to 10 (0=lowest intensity and 10= highest intensity).
12 secondary outcomes
Variation of averaged weekly frequency (number of episodes) of craving episodes between start and end of treatment.
Time frame: 5 weeks
Variation of averaged weekly duration (cumulative duration of all episodes) of craving episodes between start and end of treatment.
Time frame: 5 weeks
Variation of averaged weekly intensity, frequency and duration of craving episodes between start of treatment and 4 weeks after the end of treatment.
Time frame: 9 weeks (5 weeks of treatment +4 weeks of follow up after treatment)
Variation of averaged weekly frequency of the BA episodes: (i) between start and end of treatment and (ii) between start of treatment and 4 weeks after the end of treatment.
Time frame: 9 weeks
Variation of averaged weekly duration of the BA episodes: (i) between start and end of treatment and (ii) between start of treatment and 4 weeks after the end of treatment.
Time frame: 9 weeks
Variation of averaged weekly intensity of the BA episodes: (i) between start and end of treatment and (ii) between start of treatment and 4 weeks after the end of treatment.
Time frame: 9 weeks
Overall clinical improvement, assessed though the Clinical Global Impression - Improvement (CGI-I) scale.
Time frame: 9 weeks
Overall clinical improvement, assessed though the GGI - Efficacy Index (CGI-EI).
Time frame: 9 weeks
Variation of averaged weekly use of psychoactive substances (including nicotine) and daily life behaviors of interest (gambling, sex, food) between start of treatment and 4 weeks after the end of treatment
Time frame: 9 weeks
Number, type and severity of self-reported adverse side effects, during either weeks of treatment at a dosage of 18 mg/d or 36 mg/d.
Time frame: 9 weeks
Mutation(s) associated with non-response to nalmefene treatment
Time frame: 9 weeks
Sociodemographic, medical and clinical data, especially psychiatric and addictive co-morbidities assessed with the Mini International Neuropsychiatric Interview - Simplified (MINI-S) and the age of the BA
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Marie GRALL-BRONNEC principal investigator
Nantes University Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nalmefene in people with Behavioural Addiction, run by Nantes University Hospital at 13 sites in France.
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 6 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie GRALL-BRONNEC (+33240847620, marie.bronnec@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of averaged intensity of craving episodes between start and end of treatment. (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.