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

NCT ID: NCT06459609

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-10-01

Brief Summary

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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

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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.

Conditions

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Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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P - SP

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

Group Type OTHER

protein supplementation

Intervention Type DIETARY_SUPPLEMENT

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.

SP - P

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

Group Type OTHER

protein supplementation

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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protein supplementation

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de PAU

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CH de Pau

Pau, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Alice SERIS

Role: CONTACT

0559726997

Facility Contacts

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Emmanuel Augeraud

Role: primary

Other Identifiers

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2024-A01230-47

Identifier Type: -

Identifier Source: org_study_id

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