Trial reportJournal of addiction medicine
Ondansetron Does Not Reduce Withdrawal in Patients With Physical Dependence on Chronic Opioid Therapy.
Trial report in Journal of addiction medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01549652 (5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence), which is not on this map. Cited by 8 papers.
What it found
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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.
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.
5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence
Who cites it
8 citing papers in PubMed, 12 citations in OpenAlex.
- A Scoping Review of Non-Opioid Therapeutics for Opioid Withdrawal: Translational Relevance to Neonatal Opioid Withdrawal Syndrome (NOWS) Research.Clinical and translational science · 2026Article
- Xenon gas as a potential treatment for opioid use disorder, alcohol use disorder, and related disorders.Medical gas research · 2025Review
- Optimizing a therapy for opiate use disorders: Characterizing ondansetron pharmacokinetics in blood and brain.Clinical and translational science · 2023Article
- Tapping into 5-HTInternational journal of molecular sciences · 2021Review
- Kratom Alkaloids, Natural and Semi-Synthetic, Show Less Physical Dependence and Ameliorate Opioid Withdrawal.Cellular and molecular neurobiology · 2021Article
- Review
- Non-Opioid Neurotransmitter Systems that Contribute to the Opioid Withdrawal Syndrome: A Review of Preclinical and Human Evidence.The Journal of pharmacology and experimental therapeutics · 2019Review
- A Flawed Design Produces Flawed Results.Journal of addiction medicineArticle
Corrections and comments
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Authors and funding
13 authors at 2 institutions in 1 country.
Funding
Abstract
objectivesIndividuals taking opioids for an extended period of time may become physically dependent, and will therefore experience opioid withdrawal should they stop taking the medication. Previous work in animal and human models has shown that the serotonin (5-HT3) receptor may be implicated in opioid withdrawal. In this study, we investigated if ondansetron, a 5-HT3-receptor antagonist, could reduce the symptoms of opioid withdrawal after chronic opioid exposure in humans.
methodsIn this double-blinded, randomized, crossover study, 33 chronic back pain patients (N = 33) were titrated onto sustained-release oral morphine for 30 days. After titration, participants attended 2 study sessions, 1 week apart, in which opioid withdrawal was induced with intravenous naloxone, with or without 8 mg intravenous ondansetron pretreatment. Opioid withdrawal symptoms were assessed by a blinded research assistant (objective opioid withdrawal score [OOWS]) and by the research participant (subjective opioid withdrawal score [SOWS]).
resultsClinically significant signs of withdrawal were observed during both the ondansetron (ΔOOWS = 3.58 ± 2.22, P < 0.0001; ΔSOWS = 12.48 ± 11.18, P < 0.0001) and placebo sessions (ΔOOWS = 3.55 ± 2.39, P < 0.0001; ΔSOWS = 12.21 ± 10.72, P < 0.0001), but no significant differences were seen between the treatment sessions in either the OOWS or SOWS scores.
conclusionWe hypothesized that ondansetron would reduce opioid withdrawal symptoms in human subjects, but found no difference in withdrawal severity between ondansetron and placebo sessions. These findings suggest that more investigation may be necessary to determine if 5-HT3-receptor antagonists are suitable treatment options for opioid withdrawal.
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Registered trials
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 OpenQuestion graph.