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NAlmefene versus placebo in addition to treatment as usual on craving in Behavioural Addictions (NABAb)
EU CTIS ID: 2022-500085-96-00
What this study is testing
To assess the efficacy of nalmefene versus placebo as an add-on to treatment as usual for reducing intensity of craving episodes in patients with Behavioural Addictions (Gambling Desorder, Sexual Addiction, Food Addiction), at the end of treatment at maximum dosage tolerated.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males and females ≥ 18 years old
- Patient already in care or newly initiating care in Addictology departments for a behavioural addiction, diagnosed with current : - Gambling disorder / - Food addiction / - Or Sexual addiction.
- Able to regularly assess and report their craving episodes on a weekly diary
- Who provide their written informed consent
- Affiliated with French social security system or beneficiary from such system
- Having presented at least one episode of craving with an intensity ≥ 4/10 at the NRS during the week prior to inclusion
You likely can't join if
- 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.)
- 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)
See the full eligibility criteria
Who can join
- Males and females ≥ 18 years old
- Patient already in care or newly initiating care in Addictology departments for a behavioural addiction, diagnosed with current : - Gambling disorder / - Food addiction / - Or Sexual addiction.
- Able to regularly assess and report their craving episodes on a weekly diary
- Who provide their written informed consent
- Affiliated with French social security system or beneficiary from such system
- 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, and have a negative pregnancy 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 and follicle stimulating hormone levels corresponding to post-menopausal levels; or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy.
What rules you out
- 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.)
- 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
- 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 / - 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.