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Compares treatment options for Behavioural Addiction
Official title NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions
ClinicalTrials.gov ID: NCT05540288
What this study is testing
What is Nalmefene?
Nalmefene is an investigational medicine, being studied as a potential treatment for behavioural addiction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pre-
- Males and females ≥ 18 years old
- Patient already in care or newly initiating care in Addictology departments for a beharioural addiction, diagnosed with current:
- Gambling disorder [NORC DSM Screen for Gambling Problems (NODS), revised for DSM-5]
- Food addiction [Yale Food Addiction Scale (YFAS), revised for DSM-5]
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...
- 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...
- 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;
See the full eligibility criteria
- Pre-
- Males and females ≥ 18 years old
- Patient already in care or newly initiating care in Addictology departments for a beharioural addiction, diagnosed with current:
- Gambling disorder [NORC DSM Screen for Gambling Problems (NODS), revised for DSM-5]
- Food addiction [Yale Food Addiction Scale (YFAS), revised for DSM-5]
- Or Sexual addiction [interview adapted from the NODS to explore the diagnostic criteria proposed by Carnes et al. (2012): NODS-SA]
- 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 (Recommendations related to contraception and pregnancy testing in clinical trials v1.1), and have a negative pregnancy test (urine test) prior to receiving...
- 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...
- or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented).
- 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;
- 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...
- 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 treatment study during the last month or expected participation to another treatment study during participation to the NABAB study.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Brest, France
- Clermont-Ferrand, France
- Dijon, France
- La Rochelle, France
- Lyon, France
- Montpellier, France
- Nantes, France
- Nîmes, France
- Strasbourg, France
- Tours, France
- Villejuif, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Brest, France; Clermont-Ferrand, France; Dijon, France; La Rochelle, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.