Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05540288

NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions

Led by Nantes University Hospital · Updated on 2025-02-12

266

Participants Needed

13

Research Sites

221 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Pre-inclusion Criteria:

  • 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 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).
Not Eligible

You will not qualify if you...

  • 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 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.

AI-Screening

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Trial Site Locations

Total: 13 locations

1

CHU de Besançon

Besançon, France

Not Yet Recruiting

2

CHU de Bordeaux

Bordeaux, France, 33000

Actively Recruiting

3

CHRU de Brest

Brest, France, 29200

Actively Recruiting

4

CHU de Clermont Ferrand

Clermont-Ferrand, France, 63000

Actively Recruiting

5

CHU de Dijon

Dijon, France, 21000

Not Yet Recruiting

6

CH de La Rochelle

La Rochelle, France, 17000

Actively Recruiting

7

Hospices Civils de Lyon

Lyon, France, 69000

Actively Recruiting

8

CHU de Montpellier

Montpellier, France, 34295

Not Yet Recruiting

9

CHU de Nantes

Nantes, France

Actively Recruiting

10

CHU de Nîmes

Nîmes, France, 30000

Actively Recruiting

11

Hôpitaux Universitaires de Strasbourg

Strasbourg, France, 67000

Actively Recruiting

12

CHRU de Tours

Tours, France, 37000

Actively Recruiting

13

Hôpital Paul Brousse

Villejuif, France, 94800

Actively Recruiting

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Research Team

M

Marie GRALL-BRONNEC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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