Clinical trial NCT06459609: Effect of Protein Supplementation on Craving in Subjects Hospitalised for Addiction Treatment
Official title: Effect of Protein Supplementation on Craving in Subjects Hospitalised for Addiction Treatment. Monocentric Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Addiction
Keywords: addiction
craving
protein supplementation
Lead sponsor: Centre Hospitalier de PAU
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Moncentric pilot study conducted in the addictology department of the Pau Hospital, designed to demonstrate the benefit of protein supplementation on craving in patients with a substance use disorder at the start of their treatment for addiction.

This study will be conducted according a crossover design with a one-week phase with protein supplementation (P) and a one-week phase without protein supplementation (SP).

Detailed description: Addiction is a chronic psychiatric disorder characterised by the loss of control over the use of rewarding substances or behaviours, despite the accumulated damage. Craving, defined as an irrepressible, obsessive craving, is a key early symptom of addiction. Protein supplementation could reduce this craving. Nutritional abnormalities aggravate addictions but no study have directly assessed the impact of protein supplementation on craving. Evidence suggests that protein supplementation reduces cravings for sugary and hyperpalatable foods, which could extend to rewarding substances. The hypothesis is that this supplementation reduces the intensity, duration and frequency of craving in withdrawal patients by influencing dopaminergic reward circuits.

Protein supplementation takes the form of a powder sachet mixed with yoghurt or compote. It will be given twice a day, at the same time (8am and 4pm).

Patients will be enrolled at the admission to the addiction unit. They will be assessed psychologically, addictologically and nutritionally for one week and then will be randomised. Patients will be asked to assess their cravings, dietary needs, consumption of addictive substances and palatable foods.

Eligibility criteria: Inclusion Criteria:

* Male and female
* Aged 18 and over
* Admitted for complex care in the addictology department
* Person affiliated to or benefiting from a social security scheme
* Free, informed and written consent signed by the participant and the investigator

Exclusion Criteria:

* Allergy to milk protein
* Admitted to hospital for less than 3 weeks
* Severe somatic or psychiatric pathology incompatible with understanding assessment tools
* Difficulty understanding and/or writing French
* Presumed non-compliant in completing the patient diary
* Person participating in another research study with an exclusion period still in progress
* Person under legal protection (guardianship, curatorship)

Primary outcomes:
measure: Evolution of craving for the main substance
timeFrame: This outcome will be assessed twice a day (morning and afternoon) from day 8 to day 21, during the period with and without protein supplementation.
Secondary outcomes:
measure: Food craving evolution
timeFrame: This outcome will be assessed twice a day (morning and evening) from Day 8 to Day 21 during the period with and without protein supplementation.
measure: Consumption of hyperpalatable foods
timeFrame: This outcome will be assessed every day from Day 8 to Day 21 during the period with and without protein supplementation.
measure: Influence of the severity of addiction
timeFrame: Evaluation at the inclusion
measure: Influence of psychiatric comorbidities
timeFrame: Evaluation at the inclusion
Other outcomes:
Locations:
city: Pau
country: France
facility: CH de Pau
Study officials:
References: