Effect of Protein Supplementation on Craving in Subjects Hospitalised for Addiction Treatment (CRAVPROT)

Centre Hospitalier de PAU

Status: Enrolling

Conditions: Addiction

Treatments: Dietary Supplement: protein supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06459609

2024-A01230-47

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

P - SP

Other group

Description:

1 week with protein supplementation (P) then one week without protein supplementation (SP)

Treatment:

Dietary Supplement: protein supplementation

SP - P

Other group

Description:

1 week without protein supplementation (SP) then one week with protein supplementation (P)

Treatment:

Dietary Supplement: protein supplementation