Evidence map›Paper›PMID 39204082›Full record

ArticlePharmaceuticals (Basel, Switzerland)2024

A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Effectiveness and Safety of Melatonin and Three Formulations of Floraworks Proprietary TruCBN™ for Improving Sleep.

Antonija Kolobaric, Jessica Saleska, Susan J Hewlings, Corey Bryant, Christopher S Colwell, Christopher R D'Adamo, Jeff Chen, Emily K Pauli

Abstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. A sleepy cannabis constituent: cannabinol and its active metabolite influence sleep architecture in rats.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Antonija KolobaricRadicle Science, Inc., Del Mar, CA 92014, USA.ORCID 0000-0001-7326-585X
Jessica SaleskaRadicle Science, Inc., Del Mar, CA 92014, USA.
Susan J HewlingsRadicle Science, Inc., Del Mar, CA 92014, USA.
Corey BryantRadicle Science, Inc., Del Mar, CA 92014, USA.
Christopher S ColwellDepartment of Psychiatry & Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, CA 90095, USA.
Christopher R D'AdamoDepartment of Family and Community Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA.ORCID 0000-0002-2415-8158
Jeff ChenRadicle Science, Inc., Del Mar, CA 92014, USA.
Emily K PauliRadicle Science, Inc., Del Mar, CA 92014, USA.ORCID 0009-0005-3700-814X

Funding

Floraworks 00000000
6 · The paper itself

Abstract

The phytocannabinoid cannabinol (CBN) has a potential mechanism of action as an alternative sleep aid but there is minimal evidence to support its effectiveness. The aim of this randomized, double-blind, placebo-controlled study was to assess the safety and effects of three formulations of a hemp-derived CBN sleep aid, TruCBN™ [25 mg (n = 206), 50 mg (n = 205), 100 mg (n = 203)], on sleep quality (PROMIS Sleep Disturbance 8A), relative to placebo (n = 204). The effectiveness and safety of these formulations relative to 4 mg of melatonin (n = 202) was assessed. Exploratory measures were stress (PROMIS Stress 4A), anxiety (Anxiety 4A), pain (PROMIS™ PEG), and well-being (WHO 5). All groups and the 4 mg melatonin group experienced significant improvement in sleep quality relative to the placebo group with no significant differences between any group and the melatonin group. Participants taking 100 mg showed a larger decrease in stress compared to the placebo group. There were no significant differences in anxiety, pain, well-being, or the frequency of side effects between any group and the placebo group. There was no significant difference in improvements in sleep quality between any of the treatment groups and the 4 mg melatonin group. Orally ingested CBN, at 25 mg, 50 mg, and 100 mg, is a safe and effective alternative for the improvement of sleep.

Indexed as

cannabinol (CBN)decentralized clinical trialphytocannabinoidsPROMISsleep

Identifiers

PMID39204082
PMCPMC11357382

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.