Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05540288 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: NABAb
StatusRecruiting
PhasePhase 3
Started2023-03-31
View on ClinicalTrials.gov ↗

Amendment history

2025-02-10
minor
Study Status, Oversight, Contacts/Locations v2
Primary completion date2025-07→2027-07
Completion date2025-07→2027-07
Study sites11→13
2023-11-07
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-02→2025-07
Completion date2025-02→2025-07
Start dateestimated 2022-11→confirmed 2023-03-31
Eligibility criteria+78 characters
[...] een 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 [...] test for women of childbearing age) or breastfeeding woman; Patient refusing contraceptive measures; Trusteeship; Major cognitive impairment; Not fluent in Frenc [...]
Study sites11 entries, revised
CHRUCHU de LilleBesançon
2022-09-09
minor
Original filing
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.
Trial Details
NCT Number NCT05540288
Lead Sponsor Nantes University Hospital
Conditions Behavioural Addiction
Enrollment 266 participants
Start Date 2023-03-31
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-02-12