# PP-01 for Cannabis Withdrawal: What a 14-Person Trial Found > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/pp01-cannabis-withdrawal-proof-of-concept/ > **Published:** 2026-09-13T12:00:08-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T10:45:00-04:00 > **Clinical Summary:** PP-01 for cannabis withdrawal improved several outcomes in a 14-person randomized trial, but the evidence remains preliminary and sponsor funded. --- CED Clinical Relevance #76 High Clinical Relevance A randomized, double-blind, placebo-controlled crossover trial directly addresses cannabis withdrawal and an important treatment gap. The evidence remains preliminary because only 14 adults completed a five-night inpatient proof-of-concept study, and the sponsor funded the work. Search-demand and engagement components are editorially inferred because current GSC data were unavailable. Clinical Insight | CED Clinic A Phase 1b/2a crossover trial tested PP-01, an investigational combination of nabilone and gabapentin, against placebo in 14 adults with moderate to severe cannabis use disorder during a five-night inpatient stay. The PubMed abstract reports statistically significant improvements in withdrawal severity, withdrawal bothersomeness, sleep quality, cravings, and objective withdrawal measures. It also reports mild adverse events and no serious adverse events. These findings justify further study, but the very small, short, sponsor-funded trial does not establish routine effectiveness, long-term safety, relapse prevention, or a place in clinical practice. Cannabis WithdrawalCannabis Use DisorderRandomized TrialNabiloneGabapentin AudienceAdults considering treatment for cannabis use disorder, clinicians, addiction-care teams, caregivers, and cannabis-science readers Primary TopicPP-01 for cannabis withdrawal syndrome Source[Read the full source](https://pubmed.ncbi.nlm.nih.gov/42717263/) A randomized crossover trial in 14 adults found that investigational PP-01 was associated with improved cannabis withdrawal measures, sleep, and craving during a five-night inpatient stay. The result is promising but far too preliminary to establish routine treatment effectiveness. What This Study Teaches Us This study provides an early controlled signal that a fixed investigational combination of nabilone and gabapentin may reduce several cannabis withdrawal measures under closely supervised inpatient conditions. It also shows why larger, longer, independently scrutinized trials are needed before the combination can be considered established care. Why This Matters Cannabis withdrawal can interfere with attempts to stop or reduce use, and there is no FDA-approved medication specifically for cannabis use disorder. A controlled medication signal is clinically relevant, especially when withdrawal, sleep disruption, and craving reinforce return to use. The question is whether the signal survives larger trials and translates beyond a short inpatient setting. Study SnapshotStudy TypePhase 1b/2a randomized, double-blind, placebo-controlled crossover trialSettingFive-night inpatient studyParticipants14 adults with moderate to severe cannabis use disorderCannabis HistoryDaily or near-daily use of at least 1 gram per day and a history of cannabis withdrawalInterventionPP-01, an investigational combination of nabilone and gabapentinComparatorPlaceboPrimary Reported MeasuresPatient-diary ratings of withdrawal symptom severity and bothersomenessReported FindingsLower withdrawal severity and bothersomeness, with improvements in sleep, craving, and objective withdrawal measuresReported SafetyMild adverse events and no serious adverse events during the short studyFundingPleoPharma, Inc.; three authors listed PleoPharma affiliationsPublished OnlineSeptember 9, 2026PMID42717263DOI10.1111/ajad.70202 Clinical Bottom Line PP-01 produced an encouraging withdrawal signal in a tightly controlled 14-person trial, but the study is an early proof of concept, not evidence that the combination is ready for routine prescribing. What the Trial Reported The PubMed abstract reports that PP-01 reduced the severity and bothersomeness of cannabis withdrawal symptoms compared with placebo. The reported p values were .0222 for severity and .0063 for bothersomeness. Sleep quality and cannabis craving reportedly improved after the first dose through discharge, and the abstract also describes statistically significant improvement in objective withdrawal measures. The accessible record does not provide the effect sizes or confidence intervals needed to judge the magnitude and precision of those changes. Why the Controlled Design Matters Randomization, blinding, placebo control, and crossover exposure make this more informative than an uncontrolled case series or sponsor announcement. Each participant could contribute information under both treatment conditions, which can be useful in a small early-phase study. The design still operated within a five-night inpatient setting and enrolled only 14 adults. A controlled design reduces some biases, but it cannot compensate fully for a very small sample, brief observation, or uncertainty about how treatment performs in ordinary outpatient care. The Sponsor Context Belongs in the Result The authoritative PubMed record lists PleoPharma as the funder and identifies three authors with PleoPharma affiliations. Sponsor involvement does not invalidate a study, and early product development commonly involves the company developing the intervention. It does increase the importance of complete methods, prespecified outcomes, transparent adverse-event reporting, larger replication, and independent review. Because the full article could not be retrieved here, this report does not infer unreported protocol details, analytic choices, or conflicts beyond what PubMed explicitly lists. What Would Make the Evidence Clinically Persuasive Larger parallel-group trials should test whether PP-01 produces clinically meaningful withdrawal relief across diverse patients and care settings. Outcomes should include retention, abstinence or reduced use, return to use, sleep, craving, function, adverse effects, discontinuation, and longer follow-up. The field also needs clarity about which component contributes benefit, how the combination compares with behavioral treatment and other medication strategies, and whether any short-term symptom improvement helps patients sustain their goals after the supervised withdrawal period ends. How Strong Is This Evidence? The study used a randomized, double-blind, placebo-controlled crossover design in adults with moderate to severe cannabis use disorder. That design supports a credible early efficacy signal under controlled conditions. Its strength is limited by the 14-person sample, five-night inpatient duration, early development phase, incomplete effect-size information in the accessible abstract, and sponsor funding. Where This Paper Deserves Skepticism Statistical significance in a 14-person proof-of-concept trial does not establish a stable or clinically important treatment effect. The accessible abstract does not report confidence intervals, absolute changes, crossover sequence details, washout adequacy, carryover analyses, attrition, individual adverse events, or longer outcomes. Those omissions reflect unavailable full text, not claims that the paper failed to address them. What This Paper Does Not Show The trial does not show that PP-01 is FDA approved, appropriate for self-treatment, superior to behavioral care, effective for maintaining abstinence, or safe over months of use. It does not establish which patients are most likely to benefit, whether either component is necessary, or whether the findings generalize beyond 14 adults in a short inpatient protocol. How This Fits With the Broader Clinical Conversation Cannabis withdrawal can include irritability, sleep disturbance, anxiety, appetite change, restlessness, depressed mood, and physical discomfort. Symptom burden varies, and treatment planning should also consider co-occurring psychiatric conditions, other substance use, medication risks, social supports, and the patient’s own goals. Medication development for cannabis use disorder has produced signals from several agents without an FDA-approved pharmacotherapy. Behavioral interventions remain central to care. A new medication candidate should be judged by clinically meaningful outcomes, reproducibility, safety, and whether it helps people function and sustain change outside a research unit. Dr. Caplan’s Take *This is a genuinely interesting result because it tested a medication strategy against placebo in people experiencing a clinically important barrier to change. Withdrawal, poor sleep, and craving can make a planned reduction or quit attempt feel impossible, so relief during that window could matter.* *The proportionate response is curiosity, not adoption. Fourteen participants and five inpatient nights can justify the next trial, but they cannot define routine treatment. I would want larger samples, clear effect sizes, longer follow-up, careful safety data, and evidence that short-term relief improves outcomes patients actually value.* What a Careful Reader Should Take Away PP-01 deserves further controlled study for cannabis withdrawal, while current clinical decisions should recognize that this evidence remains preliminary and sponsor-linked. Evidence Interpretation Guide Table of Contents - [How to Interpret an Early Cannabis Withdrawal Medication Signal](#How_to_Interpret_an_Early_Cannabis_Withdrawal_Medication_Signal)[A Four-Step Reading Frame](#A_Four-Step_Reading_Frame) - [Eight Ways to Read the PP-01 Withdrawal Trial](#Eight_Ways_to_Read_the_PP-01_Withdrawal_Trial)[An Encouraging Signal Is Not a Do-It-Yourself Protocol](#An_Encouraging_Signal_Is_Not_a_Do-It-Yourself_Protocol) - [Withdrawal Relief Must Connect to Meaningful Recovery Outcomes](#Withdrawal_Relief_Must_Connect_to_Meaningful_Recovery_Outcomes) - [Crossover Control Helps, but Fourteen Participants Still Limit Certainty](#Crossover_Control_Helps_but_Fourteen_Participants_Still_Limit_Certainty) - [Five Nights Cannot Define a Long-Term Safety Profile](#Five_Nights_Cannot_Define_a_Long-Term_Safety_Profile) - [Support the Withdrawal Plan Without Treating One Medication as the Plan](#Support_the_Withdrawal_Plan_Without_Treating_One_Medication_as_the_Plan) - [This Publication Adds Results to Earlier Development News](#This_Publication_Adds_Results_to_Earlier_Development_News) - [Sponsor Involvement Requires Transparency, Not Automatic Dismissal](#Sponsor_Involvement_Requires_Transparency_Not_Automatic_Dismissal) - [The Next Trial Must Test Durability and Real-World Value](#The_Next_Trial_Must_Test_Durability_and_Real-World_Value) - [Frequently Asked Questions](#Frequently_Asked_Questions)[Related](#Related) ## How to Interpret an Early Cannabis Withdrawal Medication Signal The study is stronger than an uncontrolled announcement because it used randomized, blinded, placebo-controlled methods. It is still a 14-person, five-night proof-of-concept trial, so the result should guide research rather than routine prescribing. ### A Four-Step Reading Frame **Evidence type**Recognize this as an early Phase 1b/2a crossover trial, not a definitive effectiveness trial. **Population and setting**Keep the findings anchored to 14 adults with moderate to severe cannabis use disorder during a five-night inpatient protocol. **Outcome meaning**Separate statistically significant withdrawal ratings from evidence about long-term abstinence, reduced use, relapse, or daily function. **Independence and safety**Read sponsor involvement, limited accessible safety detail, and the need for larger replication as part of the evidence. The Research Question Can investigational PP-01 reduce cannabis withdrawal symptoms during a short supervised abstinence period? The Patient Question Does this small trial mean PP-01 is an available or proven treatment for cannabis use disorder? The Bottom Line No. The findings support continued research, but PP-01 remains investigational and the trial does not establish routine clinical effectiveness. CED Perspective Lens ## Eight Ways to Read the PP-01 Withdrawal Trial Patient, clinical, methods, safety, caregiver, evidence, ethics, and research perspectives Lens OverviewEach perspective stays within the peer-reviewed PubMed record and treats the result as an early controlled signal. The central task is to distinguish symptom improvement during five supervised nights from proof of long-term recovery benefit. #### An Encouraging Signal Is Not a Do-It-Yourself Protocol For someone struggling with cannabis withdrawal, a medication signal involving sleep, craving, and symptom burden may feel immediately relevant. The trial suggests that PP-01 could reduce several withdrawal measures during a closely monitored inpatient stay, but only 14 adults participated and the observation period lasted five nights. PP-01 combines nabilone and gabapentin and remains investigational. The study does not provide a basis for combining available medications without supervision. Both agents can affect alertness and coordination, and individual risks depend on health history, other medications, other substance use, and the clinical goal being pursued. Lens takeawayTreat the result as research progress, not instructions for unsupervised medication use. #### Withdrawal Relief Must Connect to Meaningful Recovery Outcomes The trial addresses a practical treatment target. Irritability, sleep disruption, craving, and other withdrawal symptoms can destabilize a reduction or quit attempt. A medication that reliably reduces that burden could support engagement during an early high-risk period. The available abstract does not establish effects on sustained abstinence, reduced use, relapse, retention, function, or outpatient adherence. Until larger trials report those outcomes, clinicians should continue evidence-based behavioral care, assess co-occurring psychiatric and substance-use conditions, plan for sleep and safety, and avoid presenting PP-01 as established treatment. Lens takeawayShort-term symptom relief matters only if it safely supports outcomes patients value. #### Crossover Control Helps, but Fourteen Participants Still Limit Certainty A randomized, double-blind, placebo-controlled crossover design can improve efficiency because participants contribute information under both conditions. This structure is useful for early signal detection and is more rigorous than comparing an open treatment group with historical expectations. The accessible abstract does not report the crossover sequence, washout details, carryover assessment, effect sizes, confidence intervals, missing-data handling, or individual participant patterns. With 14 adults, a few observations can materially affect estimates. Statistical significance therefore needs to be read alongside sample size, precision, reproducibility, and the clinical importance of the measured change. Lens takeawayThe design supports a signal, while the sample and missing detail limit confidence. #### Five Nights Cannot Define a Long-Term Safety Profile The abstract reports mild adverse events and no serious adverse events. That is reassuring within the observed inpatient window, but a 14-person, five-night study has little power to detect uncommon events, delayed effects, discontinuation problems, or risks that emerge with longer exposure. Nabilone and gabapentin can both affect the central nervous system. The abstract does not provide event-by-event safety detail or establish safety with alcohol, sedatives, other medications, driving, pregnancy, major medical illness, or complex psychiatric conditions. Those unanswered questions should remain explicit until larger trials provide more complete evidence. Lens takeawayShort-term tolerability is useful, but it is not a comprehensive safety conclusion. #### Support the Withdrawal Plan Without Treating One Medication as the Plan Caregivers often see the sleep disruption, irritability, anxiety, and craving that can accompany a cannabis reduction or quit attempt. This trial validates withdrawal as a meaningful treatment target and suggests that medication research may eventually add options to structured support. For now, practical support still includes calm communication, predictable routines, attention to hydration and nutrition, reduced access to triggers, connection with professional care, and urgent evaluation when severe depression, suicidal thinking, psychosis, dangerous agitation, or other acute concerns appear. One preliminary medication result should not replace a broader plan. Lens takeawayWithdrawal support works best as a coordinated plan, not a single-product promise. #### This Publication Adds Results to Earlier Development News Earlier CED coverage described PP-01 Phase 3 enrollment and grant support. Those milestones showed that development was advancing, but they did not provide peer-reviewed clinical results from the newly indexed paper. The September 2026 publication adds a randomized proof-of-concept dataset. The distinction matters. Trial registration, first-patient dosing, and funding are signals about a research program. They are not evidence of efficacy. This paper supplies early controlled outcome data, while the ongoing larger program will need to show whether the signal is reproducible, clinically meaningful, durable, and safe across a broader population. Lens takeawayNew peer-reviewed results add evidence that earlier development announcements could not provide. #### Sponsor Involvement Requires Transparency, Not Automatic Dismissal PleoPharma funded the study, and PubMed lists three authors with company affiliations. Commercial sponsorship is common in drug development because the sponsor owns the program and finances trials. The ethical requirement is transparent reporting, prespecification, complete safety disclosure, and results that can be independently evaluated. Readers should neither reject the findings solely because a company was involved nor treat sponsor-reported conclusions as settled. The appropriate response is proportionate scrutiny. Larger studies, accessible protocols, complete statistical reporting, regulatory review, and independent replication can show whether the early result is robust enough to inform care. Lens takeawayTransparent sponsorship context helps readers judge evidence without reflexive trust or dismissal. #### The Next Trial Must Test Durability and Real-World Value The proof-of-concept signal now needs confirmation in a substantially larger sample. Prespecified primary outcomes, clinically interpretable effect sizes, confidence intervals, participant flow, detailed adverse events, and transparent handling of crossover or missing data will be important for judging reproducibility. Longer studies should follow withdrawal symptoms into outpatient care and measure retention, abstinence, reduced use, relapse, sleep, craving, quality of life, function, and treatment burden. Comparative or factorial designs could help separate the contributions of nabilone and gabapentin. Diverse recruitment would also clarify whether benefits and risks differ across patient groups. Lens takeawayReplication should connect early symptom change to durable, patient-important outcomes. 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/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Physician-Led, Whole-Person Care A doctor who takes the time to truly understand you. Personal care that starts with listening and is guided by experience and ingenuity. Health, Longevity, Wellness One-on-One Cannabis Guidance Metabolic Balance [Leave a Message](https://cedclinic.com/contact/) [Metabolic Care](https://cedclinic.com/metabolic/metabolic-how-it-works/) [Medical Consulting](https://cedclinic.com/book/) [Cannabis Care](https://cedclinic.com/book/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Share this Evidence Watch [X](https://twitter.com/intent/tweet?text=PP-01+for+Cannabis+Withdrawal%3A+What+a+14-Person+Trial+Found&url=https%3A%2F%2Fcedclinic.com%2Fpp01-cannabis-withdrawal-proof-of-concept%2F) [LinkedIn](https://www.linkedin.com/sharing/share-offsite/?url=https%3A%2F%2Fcedclinic.com%2Fpp01-cannabis-withdrawal-proof-of-concept%2F) [BlueSky](https://bsky.app/intent/compose?text=PP-01+for+Cannabis+Withdrawal%3A+What+a+14-Person+Trial+Found%20https%3A%2F%2Fcedclinic.com%2Fpp01-cannabis-withdrawal-proof-of-concept%2F) [Instagram](https://www.instagram.com/drcaplan/) [Substack](https://doctorapprovedcannabis.substack.com/) [RSS](https://cedclinic.com/feed/) Source: [Proof-of-concept trial of PP-01 for mitigating cannabis withdrawal syndrome in participants with cannabis use disorder](https://pubmed.ncbi.nlm.nih.gov/42717263/) Related Reading at CED ClinicContinue exploring the evidence[Cannabis Use Disorder Risk, Internet Use, and Depression](https://cedclinic.com/cannabis-use-disorder-internet-use-depression/) A recent CED study review on mental-health context among adults at high risk for cannabis use disorder. [Review the clinical context](https://cedclinic.com/cannabis-use-disorder-internet-use-depression/)[Cannabinoids in Mental Health Treatment](https://cedclinic.com/cannabinoids-in-mental-health-treatment-a-systematic-review-of-efficacy-and-safety/) A broader systematic-review discussion of cannabinoid efficacy and safety across mental-health and substance-use conditions. [Compare the evidence](https://cedclinic.com/cannabinoids-in-mental-health-treatment-a-systematic-review-of-efficacy-and-safety/)[Cannabis Use in Cocaine Dependence Treatment](https://cedclinic.com/cannabis-use-in-cocaine-dependence-treatment-a-randomized-trial-of-buprenorphine-and-naltrexone/) Related trial context on cannabis use within treatment for another substance-use disorder. [Read the treatment context](https://cedclinic.com/cannabis-use-in-cocaine-dependence-treatment-a-randomized-trial-of-buprenorphine-and-naltrexone/) Similar Studies on CEDClinic.comEarlier coverage on closely related evidence When a new paper overlaps with earlier CED Clinic coverage, we preserve the chain instead of hiding the overlap. These links point to older related posts so readers can compare what is new, what is repeated, and how the evidence has moved. Related digest item [PleoPharma Secures NIH Grant for Phase 3 Cannabis Use](https://cedclinic.com/pleopharma-nih-grant-phase-3-trial-cannabis-treatment/) PleoPharma has been awarded a significant NIH grant to conduct a Phase 3 trial focused on cannabis use disorder. This trial aims to develop effective treatments for cannabis withdrawal, addressing a critical gap in clin… Covers a closely related topic; this CED post is older by about 11 days and gives earlier context. 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[Compare earlier coverage](https://cedclinic.com/advancing-the-first-potential-fda-approved-treatment-for-cannabis-withdrawal/) Related digest item [PleoPharma Announces 1st Patient Dosed in Phase 3 Clinical Trial for Cannabis Use Disorder](https://cedclinic.com/pleopharma-announces-1st-patient-dosed-in-phase-3-clinical-trial-for-cannabis-use-disorder/) ✦ New CED Clinical Relevance #67 Notable Clinical Interest Emerging findings or policy developments worth monitoring closely. ResearchMental HealthSafetyCBDDosingHempIndustry Why This Matters This Phase 3 trial represen… Covers a closely related topic; this CED post is older by about 82 days and gives earlier context. 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[Compare earlier coverage](https://cedclinic.com/pleopharma-announces-1st-patient-dosed-in-phase-3-clinical-trial-for-cannabis-use-disorder/) Related digest item [PleoPharma Announces First Patient Dosed in Pivotal Phase 3 Clinical Trial](https://cedclinic.com/cannabis-withdrawal-syndrome-treatment-phase-3-trial/) Cannabis withdrawal syndrome treatment is advancing with PleoPharma’s Phase 3 trial of PP-01. This medication targets withdrawal symptoms that hinder recovery. The trial aims to improve treatment outcomes for cannabis u… Covers a closely related topic; this CED post is older by about 82 days and gives earlier context. [Compare earlier coverage](https://cedclinic.com/cannabis-withdrawal-syndrome-treatment-phase-3-trial/) Related digest item [What’s in My Weed?](https://cedclinic.com/whats-in-my-weed/) ✦ New CED Clinical Relevance #67 Notable Clinical Interest Emerging findings or policy developments worth monitoring closely. ResearchSafetyCBDTHCHempIndustryDosing Clinical Summary This article examines the results of… Covers a closely related topic; this CED post is older by about 82 days and gives earlier context. [Compare earlier coverage](https://cedclinic.com/whats-in-my-weed/) Related digest item [PleoPharma, Inc. Announces First Patient Dosed in Pivotal Phase 3 Clinical Trial of PP-01 …](https://cedclinic.com/pleopharma-inc-announces-first-patient-dosed-in-pivotal-phase-3-clinical-trial-of-pp-01/) ✦ New CED Clinical Relevance #72 Notable Clinical Interest Emerging findings or policy developments worth monitoring closely. ResearchSafetyMental HealthAnxietyNeurologyDosingIndustry Why This Matters This Phase 3 trial… Covers a closely related topic; this CED post is older by about 82 days and gives earlier context. [Compare earlier coverage](https://cedclinic.com/pleopharma-inc-announces-first-patient-dosed-in-pivotal-phase-3-clinical-trial-of-pp-01/) ## Frequently Asked Questions What is PP-01? PP-01 is an investigational combination of nabilone and gabapentin being studied for cannabis withdrawal syndrome and cannabis use disorder. How many people were in the trial? The Phase 1b/2a randomized crossover trial included 14 adults with moderate to severe cannabis use disorder. What did the study compare? It compared PP-01 with placebo during a five-night inpatient crossover study. What withdrawal outcomes improved? The abstract reports improvements in withdrawal severity, withdrawal bothersomeness, sleep quality, cannabis craving, and objective withdrawal measures. Was PP-01 proven effective for cannabis use disorder? No. The trial provides an early controlled signal, but 14 participants and five inpatient nights are not enough to establish routine effectiveness or durable recovery benefit. Is PP-01 FDA approved? No. PP-01 is investigational, and there is currently no FDA-approved medication specifically for cannabis use disorder. What did the study report about safety? The abstract reports mild adverse events and no serious adverse events during the short trial. It does not establish long-term or uncommon-event safety. Who funded the study? The PubMed record lists PleoPharma, Inc. as the funder and lists three authors with PleoPharma affiliations. Can patients combine nabilone and gabapentin on their own? No. This small supervised trial does not provide instructions for unsupervised use, and medication decisions require individualized clinical assessment. Was the full article reviewed for this report? No. The Wiley article body was not retrievable through the available access routes. Study-specific claims are confined to the peer-reviewed PubMed abstract and authoritative PubMed metadata. ### Related --- ### 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).