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

NCT06459609 | Completed

• 1 other identifier: 2024-A01230-47
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Addiction

Keywords

addiction; craving; protein supplementation

Outcome Measures

Primary Outcomes (1)

• Evolution of craving for the main substance

  Evaluation of the evolution of craving for the main substance in patients with a substance use disorder in association with protein supplementation. It will be a self-assessment by the patient, using a visual analogue craving scale ranging from 1 'no craving' to 7 'extreme craving'.

  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 (4)

• Food craving evolution

  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.

• Consumption of hyperpalatable foods

  This outcome will be assessed every day from Day 8 to Day 21 during the period with and without protein supplementation.

• Influence of the severity of addiction

  Evaluation at the inclusion

• Influence of psychiatric comorbidities

  Evaluation at the inclusion

Study Arms (2)

P - SP

OTHER

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

Dietary Supplement: protein supplementation

SP - P

OTHER

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

Dietary Supplement: protein supplementation

Interventions

protein supplementation 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.

P - SP; SP - P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 under legal protection (guardianship, curatorship)

Sponsors & Collaborators

• Centre Hospitalier de PAU: lead

Study Sites (1)

CH de Pau

Pau, 64000, France

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 14, 2024
• Study Start: October 1, 2024
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)