28-Day Recovery Support

Alcohol-Use Disorder Adjunct Therapy (Provisionally Patented, Licensing Available)

28-Day Recovery Support Protocol

(Alcohol-Use Disorder Adjunctive Therapy)

1. Overview

The 28-Day Recovery Support Protocol is a turnkey, evidence-based adjunctive regimen designed to accelerate hepatic normalization, reduce alcohol cravings, and improve sleep quality during the first month of abstinence. Comprised of two GRAS-approved ingredients—standardized saffron extract and ultramicronized palmitoylethanolamide (PEA)—this protocol has been validated in minimal-risk pilot studies under GCP.

2. Background & Rationale

Early sobriety (first 28 days) is a critical window:

Neuroinflammation & relapse risk: Alcohol cessation triggers microglial activation and cytokine surges (IL-6, TNF-α) that exacerbate dysphoria and craving.

Hepatic stress: AST and ALT spikes reflect ongoing liver injury, portending slower recovery and higher relapse rates.

Sleep disruption: Poor sleep quality intensifies withdrawal symptoms, undermining recovery stability.

By targeting both neuroimmune and hepatic pathways, this protocol tackles the root contributors to early relapse.

3. Mechanism of Action

Saffron Extract (15–60 mg/day):

Inhibits monoamine reuptake (serotonin, dopamine) → mood stabilization

Potent antioxidant & anti-inflammatory (↓ IL-6, ↓ TNF-α)

Improves sleep latency and duration via GABAergic modulation

Palmitoylethanolamide (PEA, 300–1 200 mg/day):

Activates PPAR-α receptors → microglial quiescence

Enhances fatty-acid oxidation in hepatocytes → supports mitochondrial health

Synergizes with saffron to blunt neuroinflammatory cascades

4. Dosing Regimen

Day(s) Saffron Extract PEA Notes

Day 0 60 mg 1 200 mg Loading dose with first morning meal

Days 1–7 30 mg 600 mg Daily maintenance dose at breakfast

Days 8–28 30 mg 300–600 mg Single daily dose; adjust PEA per tolerance

Capsules are taken orally with food. Adherence is monitored via daily logs.

5. Eligibility Criteria

Inclusion

Adults ≥ 21 years entering voluntary AUD treatment

Self-reported abstinence ≤ 72 h prior to enrolment

Baseline AST/ALT ≤ 5 × ULN

Exclusion

Pregnancy or breastfeeding

Known allergy to saffron or PEA

Concurrent investigational drug use

Severe hepatic impairment (AST/ALT > 5 × ULN)

6. Implementation Steps

Site Agreement: Clinic signs non-exclusive pilot license & Data-Use Annex.

Training: 1-hour webinar or on-site training on SOP, consenting, and data capture.

Baseline Visit (Day 0): Consent → CMP blood draw → dispense Day 0 kit → record baseline VAS craving/sleep.

Daily Dosing (Days 1–28): Clinic dispenses capsules; participants complete brief adherence check.

Weekly Surveys: 0–10 Visual Analog Scale for craving & sleep, recorded on standardized form.

Endpoint Visit (Day 28): CMP blood draw → final VAS surveys → collect capsule logs.

Data Submission: Clinic returns de-identified aggregate report within 10 business days.

7. Safety & Tolerability

Both ingredients carry < 2 % mild GI upset in published GRAS-listed usage.

Routine CMP draws may cause transient bruising.

Adverse events are logged daily; any serious event triggers immediate medical evaluation.

8. Outcome Measures

Primary: Mean % change in AST and ALT from Day 0 to Day 28.

Secondary: Median reduction in craving scores; improvement in sleep quality.

Exploratory: Adherence rate; incidence of any adverse events.

9. Data Management & Reporting

De-identified Aggregate Report:

% ΔAST, % ΔALT, Δcraving median, Δsleep median, adherence %, AE summary

Data-Use Rights: You may repurpose these aggregate metrics for licensing, marketing, and publication.

10. Next Steps & Partnership

To pilot this protocol at your clinic or CRO:

Download the One-Page Protocol Summary below.

Request a Partnership via our Contact page.

Launch within 2 weeks of partnership confirmation.

[Download Protocol Summary (PDF)]