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NAlmefene versus placebo in addition to treatment as usual on craving in Behavioural Addictions (NABAb)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500085-96-00
Acronym
RC21_0336
Enrollment
266
Registered
2022-08-05
Start date
2023-03-31
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with gambling disorder or sexual addiction or food addiction

Brief summary

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).

Detailed description

Variation of averaged weekly frequency (number of episodes) and duration (cumulative duration of all episodes) of craving episodes between start and end of treatment., Variation of averaged weekly intensity, frequency and duration of craving episodes between start of treatment and 4 weeks after the end of treatment., Variation of averaged weekly frequency, duration and intensity (assessed through a NRS) 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., Overall clinical improvement, assessed though the Clinical Global Impression – Improvement (CGI-I) scale and the GGI – Efficacy Index (CGI-EI)., 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., 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., Mutation(s) associated with non-response to nalmefene treatment; such mutations will be identified using a NGS (Next-Generation Sequencing) panel., 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

Interventions

DRUGPlacebo for therapeutic use (capsule #3)
DRUG99
DRUG90mg of cellulose microcristaline and 0
DRUG10mg of sillice colloïde anhydre
DRUGform ARROW Génériques
DRUGSelincro 18 mg film-coated tablets

Sponsors

Centre Hospitalier Universitaire De Nantes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
Variation of averaged weekly frequency (number of episodes) and duration (cumulative duration of all episodes) of craving episodes between start and end of treatment., Variation of averaged weekly intensity, frequency and duration of craving episodes between start of treatment and 4 weeks after the end of treatment., Variation of averaged weekly frequency, duration and intensity (assessed through a NRS) 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., Overall clinical improvement, assessed though the Clinical Global Impression – Improvement (CGI-I) scale and the GGI – Efficacy Index (CGI-EI)., 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., Number, type and severity of self-reported adverse side effects, during either weeks of treatment at a d

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026