# Clinical Trial: Effect of Extended Cannabis Abstinence on PTSD Symptoms

> **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637)
> **Publisher:** CED Clinic (https://cedclinic.com)
> **Canonical URL:** https://cedclinic.com/ced-synthetic-cannabinoids-endometriosis-mental-h-2026-10-25/
> **Published:** 2026-10-25T21:19:07-04:00 | **Last Modified / Clinically Audited:** 2026-10-25T21:19:07-04:00
> **Clinical Summary:** cannabis news digest: CED Clinic analysis of 3 recent cannabis policy, science, and regulatory developments with Dr. Benjamin Caplan.

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CED Clinical Relevance #65 Verified Overview Curated multi-source overview preserving 3 verified developments.

Clinical Insight | CED Clinic
Patients presenting with chronic pelvic pain without surgical confirmation often navigate significant diagnostic uncertainty. This distress correlates directly with elevated rates of depression and increased reliance on cannabinoids for symptom relief. Clinicians should screen these individuals for mood symptoms and discuss standardized cannabis protocols rather than leaving them to unguided self-treatment. Simultaneously, cellular research on cannabichromene derivatives demonstrates potent apoptosis in prostate cancer lines at low micromolar concentrations. Understanding these therapeutic boundaries helps physicians distinguish early laboratory structural modifications from clinically actionable treatments while supporting complex patients seeking evidence-based relief.

DigestCannabis NewsRegulationPublic HealthClinical Practice

AudiencePatients, clinicians, healthcare professionals, regulators, and industry researchers.
Primary TopicClinical and policy analysis: Clinical Trial: Effect of Extended Cannabis Abstinence .
Source[Read the full source](https://pubmed.ncbi.nlm.nih.gov/42924954/)

Table of Contents

- [Clinical Trial: Effect of Extended Cannabis Abstinence on PTSD Symptoms](#Clinical_Trial_Effect_of_Extended_Cannabis_Abstinence_on_PTSD_Symptoms)[How to Interpret This Cannabis News & Regulatory Digest](#How_to_Interpret_This_Cannabis_News_Regulatory_Digest)[Three Rules for Critical Reading](#Three_Rules_for_Critical_Reading)
- [CED Perspective Lens: Eight Viewpoints on These Updates](#CED_Perspective_Lens_Eight_Viewpoints_on_These_Updates)[Understanding Pain and Self-Care Options](#Understanding_Pain_and_Self-Care_Options)
- [Addressing Complex Diagnostic Profiles](#Addressing_Complex_Diagnostic_Profiles)
- [Evaluating Product Purity and Dosing](#Evaluating_Product_Purity_and_Dosing)
- [Standardizing Access and Diagnostic Categories](#Standardizing_Access_and_Diagnostic_Categories)
- [Translating Preclinical Data to Human Trials](#Translating_Preclinical_Data_to_Human_Trials)
- [Examining Methodological Limits](#Examining_Methodological_Limits)
- [Supporting Family Members Through Diagnostic Uncertainty](#Supporting_Family_Members_Through_Diagnostic_Uncertainty)
- [Integrating Clinical Science and Patient Care](#Integrating_Clinical_Science_and_Patient_Care)
- [Frequently Asked Questions](#Frequently_Asked_Questions)[Related](#Related)

# Clinical Trial: Effect of Extended Cannabis Abstinence on PTSD Symptoms

A structured CED Clinic overview of 3 key developments in cannabis regulation, market milestones, and scientific research.

What This Study Teaches Us
Cannabichromene derivative compound 9 exhibited prostate cancer growth inhibition with GI50 values of 2.01 μM in PC-3 cells and 1.86 μM in DU-145 cells while inducing apoptosis. In a 454-patient cohort, individuals with clinically suspected endometriosis lacking pathological confirmation faced elevated depression risks (aOR 2.27, 95% CI 1.03-5.03) and reported higher cannabis use for depression (aOR 1.92, 95% CI 1.01-3.65) compared to patients with pathologically confirmed disease. A completed 12-week randomized trial evaluated motivational interviewing to achieve extended cannabis abstinence among outpatients diagnosed with co-occurring post-traumatic stress disorder and cannabis use disorder.

Why This Matters
Unconfirmed chronic pelvic pain creates psychological distress that drives self-directed cannabinoid use for mood stabilization. Synthetic minor cannabinoid structural modifications reveal targeted cellular cytotoxicity that informs future oncology drug design.

Study SnapshotPost TypeCannabis News & Regulatory Digest using canonical CED layoutItems Reviewed3 verified updatesPrimary DatesOctober 25, 2026Related Reading3 verified live CED Clinic internal linksUpdate 1Semi-Synthesis and Evaluation of Cannabichromene-Derived (Patra et al., Journal of natural products) [DOI: 10.1021/acs.jnatprod.6c00722 | PMID: 42924954]Update 2Association between clinically suspected endometriosis (Meyer et al., European journal of obstetrics & gynecology and reproductive biology: X) [DOI: 10.1016/j.eurox.2026.100500 | PMID: 42926793]Update 3Effect of Extended Cannabis Abstinence (Centre for Addiction and Mental Health Regulatory Analysis)

Clinical Bottom Line
This clinical and regulatory overview preserves key signals across 3 updates without overstatement, offering grounded guidance for patients and practitioners.

Context Across These 3 Updates

This curated cannabis news & regulatory digest brings together 3 key developments across policy movements, regulatory milestones, and public health communications. Reviewing these distinct updates side by side clarifies emerging patterns while preserving the specific clinical context of each report.

Examining these developments concurrently helps clinicians, patients, and families trace the broader trajectory of the field while grounding practical decisions in verified primary data.

Update 1: Semi-Synthesis and Evaluation of Cannabichromene-Derived Amine and Amide

**Title & Source:** [Semi-Synthesis and Evaluation of Cannabichromene-Derived Amine and Amide Analogues as Anticancer Agents.](https://pubmed.ncbi.nlm.nih.gov/42924954/) (*Journal of natural products*, 2026Oct23)

**Lead Authors & Identifiers:** Sandip Patra, Hari K Namballa, Daniel Okpattah, Ashok R Gudipally et al.. | **Primary Record:** DOI: 10.1021/acs.jnatprod.6c00722 | PMID: 42924954 Content lane: **Mechanism Watch**.

**Investigational Focus:** Researchers synthesized cannabichromene-derived amine and amide derivatives (compounds 4-13) to test their anticancer properties against the NCI-60 human tumor cell line panel. The study investigated structural modifications that optimize cellular toxicity against specific cancer subtypes.

**Key Findings & Primary Data:** Compound 9 demonstrated growth inhibition in prostate cancer lines, reaching GI50 values of 2.01 μM in PC-3 cells and 1.86 μM in DU-145 cells. The compound induced programmed cell death across tested malignant cell lines.

**Clinical Guidance:** Cell culture cytotoxicity indicates early chemical promise but does not justify clinical use in oncology patients. Physicians should direct patients toward established cancer treatments while monitoring synthetic cannabinoid developments.

**Study Boundaries:** Testing occurred exclusively in isolated cell cultures without evaluating animal toxicity, drug metabolism, or tissue bioavailability.

Update 2: Association between clinically suspected endometriosis lacking histologic evidence

**Title & Source:** [Association between clinically suspected endometriosis lacking histologic evidence and anxiety, depression and cannabidiol-containing products.](https://pubmed.ncbi.nlm.nih.gov/42926793/) (*European journal of obstetrics & gynecology and reproductive biology: X*, 2026Dec)

**Lead Authors & Identifiers:** Raanan Meyer, Jennifer Sun, Christina Lombardi, Maya Shats et al.. | **Primary Record:** DOI: 10.1016/j.eurox.2026.100500 | PMID: 42926793 Content lane: **Research Brief**.

**Investigational Focus:** A cohort study of 454 quaternary hospital patients evaluated psychological traits and cannabis use among individuals with clinically suspected endometriosis lacking pathologic confirmation. The project compared these metrics against pathologically confirmed cases and control groups.

**Key Findings & Primary Data:** Patients with negative pathology faced higher depression risks compared to confirmed cases (aOR 2.27, 95% CI 1.03-5.03). This cohort was also more likely to utilize cannabis specifically for depression management (aOR 1.92, 95% CI 1.01-3.65).

**Clinical Guidance:** Clinicians managing pelvic pain should actively screen for mood disorders, particularly when surgical confirmation is absent. Inquiring about self-directed cannabis use offers a valuable entry point for comprehensive mental health care.

**Study Boundaries:** Observational design prevents causal conclusions, and the study lacked objective data regarding cannabinoid dosing, product chemotypes, and consumption methods.

Update 3: Effect of Extended Cannabis Abstinence on PTSD Symptoms

**Title & Source:** [Clinical Trial: Effect of Extended Cannabis Abstinence on PTSD Symptoms](https://clinicaltrials.gov/study/NCT05162651) (*Centre for Addiction and Mental Health*, 2026-10-23)

**Lead Authors & Identifiers:** Centre for Addiction and Mental Health. Content lane: **Clinical Evidence Update**.

**Regulatory Context:** A completed 12-week randomized trial evaluated the impact of extended cannabis abstinence delivered via motivational interviewing among outpatients with post-traumatic stress disorder and co-occurring cannabis use disorder. The study examined symptom trajectories following reduced or halted cannabis consumption.

**Operative Findings:** The trial completed its 12-week protocol targeting structured cessation in a dual-diagnosis outpatient cohort. Specific numerical primary outcome metrics were omitted from the initial register release.

**Clinical Relevance:** Structured motivational interviewing provides a formal framework for patients attempting to reduce cannabis reliance during trauma therapy. Clinicians should closely monitor PTSD symptom stability when patients modify their cannabis consumption patterns.

**Practical Boundaries:** The brief registry entry lacks specific outcome numbers, cohort retention statistics, and statistical significance values.

How Strong Is This Evidence?
The gynecologic study evaluated a cohort of 454 patients using multivariable odds ratios, yielding observational data on psychiatric comorbidities. Laboratory synthesis of cannabichromene derivatives provided preliminary micromolar cytotoxicity metrics across standard cell lines. The PTSD trial offers randomized interventional design methodology, though specific sample sizes and numerical outcomes remain unlisted in the summary record.

Where This Paper Deserves Skepticism
Cell culture models lack physiological human metabolism, tissue distribution dynamics, and off-target organ toxicity data. The endometriosis cohort study relied on observational reporting without tracking precise cannabinoid doses, ratios, or administration methods. Potential unblinding biases and self-reported abstinence limitations affect behavioral trial completions involving cannabis use disorder.

What This Paper Does Not Show
These studies do not establish cannabichromene derivatives as active, safe human cancer treatments. The findings do not prove that cannabis cessation directly resolves underlying post-traumatic stress symptoms.

How This Fits With the Broader Clinical Conversation

Research into minor cannabinoids like cannabichromene reflects a broader shift toward isolated and modified chemical entities in pharmaceutical development. Synthetic modifications aim to enhance receptor binding affinity and cellular potency beyond what raw plant extractions achieve. Early preclinical testing on cancer cell lines provides baseline pharmacological parameters, though clinical translation requires extensive animal pharmacokinetics and safety profiling.

Concurrently, clinical research increasingly highlights how chronic pain syndromes intersect with mental health and patient self-medication strategies. Patients facing unconfirmed physical symptoms experience prolonged diagnostic delays, which compounds psychological strain. Recognizing self-directed cannabis use as a marker for unmanaged mood symptoms provides healthcare providers with actionable opportunities for comprehensive clinical care.

Editorial Commentary

*Diagnostic uncertainty exerts a heavy toll on patients. When individuals experience severe pelvic pain without clear pathological confirmation, their psychological distress rises significantly. It is logical that these patients turn to cannabinoids to manage mood symptoms alongside physical discomfort. Clinicians must meet these individuals with open, non-judgmental discussions about their self-treatment choices, validating their symptoms while offering clear guidance on safety and dosage.*

*At the laboratory bench, structural alterations to molecules like cannabichromene demonstrate how small chemical shifts alter cellular responses. Generating micromolar apoptosis in cancer lines provides valuable directional data for chemistry teams, but patients must understand that cell dish results are far removed from functional clinical therapy. Bridging the gap between early chemical discovery and real-world clinical care requires clear, honest communication about what the data currently supports.*

What a Careful Reader Should Take Away
Readers should recognize that unconfirmed chronic pain syndromes often drive mood distress and self-directed cannabis use. Preclinical minor cannabinoid research requires extensive clinical validation before translating into human medical treatments.

[https://cedclinic.com/ask](https://cedclinic.com/ask)Ask about this study:[🧠Anxiety and Mood](https://cedclinic.com/ask)[🛡️Use Disorder](https://cedclinic.com/ask)[🎗️Oncology](https://cedclinic.com/ask)[🔎This study's limits](https://cedclinic.com/ask)

Evidence Interpretation Guide

## How to Interpret This Cannabis News & Regulatory Digest

Navigating diverse cannabis studies requires balancing laboratory chemistry, observational patient cohorts, and clinical trial methodologies.

### Three Rules for Critical Reading

**Separate In Vitro Potency from Clinical Efficacy**Cell line cytotoxicity at micromolar levels indicates target binding in a dish, not human tumor clearance or safety.

**Evaluate Diagnostic Definitions in Observational Data**Distinguish between pathologically confirmed conditions and clinical suspicion to understand real symptom burdens.

**Differentiate Abstinence Protocols from Symptom Resolution**Stopping substance use in a trial evaluates behavioral intervention efficacy, not automatic disease cure.

Key Evaluation Question
How do specific chemical modifications of minor cannabinoids compare to full-spectrum plant preparations in cellular toxicity and patient outcomes?

The Patient Question
If I use cannabis to manage symptoms of unconfirmed chronic pain or mood distress, how can I safely coordinate this with my clinical team?

The Bottom Line
Objective clinical appraisal separates preliminary synthetic chemistry from validated human therapeutic applications.

CED Perspective Lens

## CED Perspective Lens: Eight Viewpoints on These Updates

Why these developments matter across clinical, patient, safety, and policy perspectives

Lens OverviewEight distinct clinical and regulatory perspectives on Clinical Trial: Effect of Extended Cannabis A.

#### Understanding Pain and Self-Care Options

Living with persistent pelvic pain without a pathologically confirmed surgical diagnosis creates severe ongoing frustration. Finding consistent relief often feels like an isolated journey, leading many individuals to explore self-directed cannabis products for mood support and physical discomfort management.

Openly sharing your complete symptom profile and daily cannabinoid choices with your healthcare provider ensures safer clinical care. Direct professional guidance helps balance mental health support while managing chronic physical pain effectively alongside conventional, evidence-based treatment options. In clinical practice, evaluating patient factors requires assessing individual tolerance, baseline functional capacity, and verifiable product testing rather than generalizing from preliminary reports alone.

Lens takeawayDiscussing self-directed cannabis use with your clinician ensures balanced care for both pain and underlying emotional distress.

#### Addressing Complex Diagnostic Profiles

Patients presenting with unconfirmed chronic pelvic pain demonstrate significantly elevated depression rates and frequent self-directed cannabinoid use. Routine clinical screening for affective symptoms provides vital direction when surgical or histopathologic evaluations yield completely negative findings during extensive diagnostic workups.

Incorporating non-judgmental inquiries regarding patient cannabis consumption helps clinicians identify individuals managing psychological distress independently. Concurrently, tracking emerging minor cannabinoid research allows physicians to answer complex patient inquiries regarding novel synthetic derivatives with objective, evidence-grounded clinical facts. In clinical practice, evaluating clinician factors requires assessing individual tolerance, baseline functional capacity, and verifiable product testing rather than generalizing from preliminary reports alone.

Lens takeawayActive mental health screening and non-judgmental cannabis history taking improve diagnostic outcomes for patients with unconfirmed pelvic pain.

#### Evaluating Product Purity and Dosing

Unregulated self-medication for chronic pelvic pain or emotional distress presents noticeable safety risks, including unverified product purity and unpredictable cannabinoid concentrations. Patients frequently consume unstudied constituent ratios without standardized clinical oversight, clear dosing parameters, or professional medical tracking.

Transitioning patients toward verified lab-tested preparations minimizes exposure to potential industrial contaminants while establishing consistent therapeutic monitoring. Structured clinical supervision allows safe evaluation of patient tolerance, potential adverse effects, and pharmaceutical drug interaction risks over extended periods. In clinical practice, evaluating safety factors requires assessing individual tolerance, baseline functional capacity, and verifiable product testing rather than generalizing from preliminary reports alone.

Lens takeawayClinical supervision and verified product testing protect self-medicating patients from contaminant exposure and adverse reactions.

#### Standardizing Access and Diagnostic Categories

Regulatory frameworks must address the gap between formal pathological disease diagnoses and symptom-based chronic pain conditions. Patients lacking pathology-confirmed diagnoses currently face administrative barriers accessing standardized medical cannabis programs, frequently encouraging unguided commercial marketplace purchasing instead.

Policy makers should align qualifying medical condition lists with real-world clinical presentations to ensure proper long-term physician oversight. Expanding regulatory research funding for synthetic minor cannabinoids further accelerates safety evaluations and standardized pharmaceutical development protocols across markets. In clinical practice, evaluating policy factors requires assessing individual tolerance, baseline functional capacity, and verifiable product testing rather than generalizing from preliminary reports alone.

Lens takeawayAligning qualifying condition policies with symptom presentation reduces unguided self-medication in commercial markets.

#### Translating Preclinical Data to Human Trials

In vitro cell culture evaluations provide valuable initial observations regarding novel synthetic cannabichromene derivatives. However, micromolar cytotoxicity assays in isolated tumor cell plates cannot predict systemic metabolic degradation, organ tissue delivery, or human therapeutic window safety parameters.

Observational human studies require detailed tracking of specific cannabinoid dosages, chemical ratios, and consumption methods to yield actionable clinical conclusions. Rigorous clinical trials remain necessary to differentiate genuine biological therapeutic responses from broader behavioral or placebo mechanisms. In clinical practice, evaluating research factors requires assessing individual tolerance, baseline functional capacity, and verifiable product testing rather than generalizing from preliminary reports alone.

Lens takeawayRigorous methodological controls and detailed dosage tracking are essential to convert preliminary cannabinoid chemistry into validated therapeutics.

#### Examining Methodological Limits

Enthusiastic claims surrounding synthetic minor cannabinoids often overlook the vast distance between dish cytotoxicity and clinical cancer therapy. Cell line mortality at micromolar concentrations frequently reflects generalized cellular toxicity rather than selective, targeted anti-tumor therapeutic efficacy.

Observational studies linking unconfirmed pelvic pain conditions to cannabis use cannot establish direct causality. Self-reported survey data lacking objective dosage verification and product verification leaves significant room for recall bias and residual confounding variables across clinical patient cohorts. In clinical practice, evaluating skeptic factors requires assessing individual tolerance, baseline functional capacity, and verifiable product testing rather than generalizing from preliminary reports alone.

Lens takeawayPreliminary bench assays and observational surveys require cautious interpretation to prevent premature therapeutic claims.

#### Supporting Family Members Through Diagnostic Uncertainty

Watching a loved one experience severe physical pain without clear medical test results creates significant emotional strain for entire families. Caregivers play an essential role in validating these ongoing struggles while encouraging formal, thorough medical evaluations from clinical specialists.

When family members turn to cannabis for mood or physical relief, caregivers should actively assist in tracking daily symptom changes and specific product usage. Encouraging open conversations with primary clinical providers ensures coordinated, safe medical care management overall. In clinical practice, evaluating caregiver factors requires assessing individual tolerance, baseline functional capacity, and verifiable product testing rather than generalizing from preliminary reports alone.

Lens takeawayCaregivers provide critical support by tracking symptom responses and facilitating open clinical communication for loved ones.

#### Integrating Clinical Science and Patient Care

Modern cannabinoid medicine requires integrating synthetic chemical discovery with compassionate, patient-centered clinical practice. Diagnostic challenges in chronic pain conditions directly impact patient mental health, overall daily wellbeing, and personal treatment choices across varied healthcare settings.

Healthcare teams must maintain rigorous scientific evaluation standards while acknowledging real-world patient self-treatment choices in clinical settings. Open communication, systematic symptom tracking, and structured evidence synthesis form the essential foundation for safe, personalized medical care. In clinical practice, evaluating takeaway factors requires assessing individual tolerance, baseline functional capacity, and verifiable product testing rather than generalizing from preliminary reports alone.

Lens takeawayBalancing rigorous scientific analysis with open patient communication delivers the safest, most effective clinical care.

Join the Conversation

Have a question about how this applies to your situation? [Ask Dr. Caplan](https://benjamincaplan.com/ask-dr-caplan)

Want to discuss this topic with other patients and caregivers? [Join the forum discussion](https://cedclinic.com/interact/discussion-forums/forum/cannabis-industry/)

 

 
 
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Source: [Primary Sources: Journal of natural products, European journal of obstetrics & gynecology and reproductive biology: X, Centre for Addiction and Mental Health](https://pubmed.ncbi.nlm.nih.gov/42924954/)

Related Reading at CED ClinicContinue exploring the evidence[Pancreatic Cancer Cannabis Trial Finds Modest THC Dose Signals for Anxiety and Sleep](https://cedclinic.com/ced-pancreatic-cancer-cannabis-trial-fi-2026-09-22/)

More on this topic: Physician appraisal of adjunctive cannabinoid therapies in oncology, symptom management, and anxiety.

[More on this topic: Cannabinoids in oncology](https://cedclinic.com/ced-pancreatic-cancer-cannabis-trial-fi-2026-09-22/)[Cannabinoids for Low Back Pain and Migraine: What Randomized Trials Actually Show](https://cedclinic.com/ced-cannabinoids-for-low-back-pain-and-2026-09-23/)

More on this topic: Rigorous physician appraisal of randomized trials investigating cannabinoid efficacy for chronic pain and migraines.

[More on this topic: Chronic pain & migraine](https://cedclinic.com/ced-cannabinoids-for-low-back-pain-and-2026-09-23/)[Cannabis Use Disorder Is Rising Among US Adults](https://cedclinic.com/cannabis-use-disorder-rising-us-adults-2026/)

More on this topic: Epidemiological evaluation of diagnostic trends, screening tools, and evidence-based patient counseling.

[More on this topic: CUD trends & screening](https://cedclinic.com/cannabis-use-disorder-rising-us-adults-2026/)

## Frequently Asked Questions

What is covered in this cannabis news & regulatory digest?

This edition reviews 3 verified developments across cannabis policy, regulatory oversight, and clinical science.

How are stories selected for CED digests?

Stories are curated from official primary sources, government agency dockets, and peer-reviewed journals, focusing on practical relevance for patients and clinicians.

Do preliminary reports establish medical efficacy?

No. Observational reports, preprints, and regulatory filings describe emerging trends and require formal clinical trials before treatment efficacy can be claimed.

How should clinicians use these updates?

Clinicians can use these updates to understand patient questions, stay current with state regulations, and maintain evidence-informed counseling.

Where can readers find Dr. Caplan's clinical insights?

Dr. Caplan provides comprehensive clinical perspectives, patient consultations, and educational resources at CEDclinic.com.

Why are multi-topic digests published instead of single stories?

Digests group related updates together to provide a broader thematic overview while preserving important nuances and methodological limits.

What is the primary role of laboratory testing in cannabis policy?

Laboratory testing verifies cannabinoid potency and screens for harmful contaminants like heavy metals, pesticides, and molds to protect consumer health.

How do state regulatory milestones impact patient access?

Administrative milestones establish the licensing rules, product categories, and retail standards that determine how and where registered patients obtain care.

What precautions should families take with medical cannabis at home?

Families should keep all medical cannabis products securely locked in child-resistant containers and clearly labeled to avoid accidental exposure.

How often does CED Clinic publish clinical and policy updates?

CED Clinic publishes regular morning, afternoon, and evening evidence reviews and news digests to keep the community informed.

 

### Related

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### Verification & Medical Governance

- **Lead Clinical Author:** Benjamin Caplan, MD
- **Credentials:** Board Certified in Family Medicine (ABFM), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House).
- **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`).
- **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/).
- **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637).
- **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).