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

Addiction Clinical Trial

— CRAVPROT  

Official title:

Effect of Protein Supplementation on Craving in Subjects Hospitalised for Addiction Treatment. Monocentric Pilot Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459609
• Other study ID #: 2024-A01230-47
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2024
• Source: Centre Hospitalier de PAU
• Contact: Alice SERIS
• Phone: 0559726997
• Email: alice.seris[@]ch-pau.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de PAU

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Food craving evolution	Food craving will be assessed by patient self-assessment 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 evening) from Day 8 to Day 21 during the period with and without protein supplementation.
Secondary	Consumption of hyperpalatable foods	Consumption of hyperpalatable foods will be assessed by patient self-evaluation, twice a day from D8 to D21 during the period with and without protein supplementation, using a visual scale assessing the extent to which the patient consumed hyperpalatable foods outside of meals, this scale ranging from 1 'not at all' to 7 'very much'.	This outcome will be assessed every day from Day 8 to Day 21 during the period with and without protein supplementation.
Secondary	Influence of the severity of addiction	Influence of the severity of addiction measured using the Addiction Severity Index (ASI) questionnaire	Evaluation at the inclusion
Secondary	Influence of psychiatric comorbidities	Influence of psychiatric comorbidities (mood disorders and anxiety disorders) assessed using the MINI (Mini International Neuropsychiatric Interview)	Evaluation at the inclusion