Evidence map›Paper›PMID 26483357›Full record

Trial reportDrug and alcohol dependence2015

Safety of oral dronabinol during opioid withdrawal in humans.

Crystal J Jicha, Michelle R Lofwall, Paul A Nuzzo, Shanna Babalonis, Samy Claude Elayi, Sharon L Walsh

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 4 pooled it
3.1field-weighted citation impact, top 10% of its field
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

25 citing papers in PubMed, 4 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Article
  7. Article
  8. Effects of ΔThe Journal of pharmacology and experimental therapeutics · 2025
    Article
  9. Article
  10. Review
  11. ΔJournal of clinical medicine · 2024
    Review
  12. Article
  13. The endocannabinoid system and breathing.Frontiers in neuroscience · 2023
    Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Therapeutic potential of opioid/cannabinoid combinations in humans: Review of the evidence.European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2020
    Review
  20. Review
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

6 authors at 2 institutions in 1 country.

Crystal J JichaUniversity of Kentucky College of Medicine (UK COM), Center on Drug and Alcohol Research, 845 Angliana Ave., Lexington, KY 40508, United States. Electronic address: crystal.jicha@uky.edu.
Michelle R LofwallUniversity of Kentucky College of Medicine (UK COM), Center on Drug and Alcohol Research, 845 Angliana Ave., Lexington, KY 40508, United States; UK COM, Department of Behavioral Science, Lexington, KY 40536, United States; UK COM, Department of Psychiatry, Lexington, KY 40509, United States. Electronic address: michelle.lofwall@uky.edu.
Paul A NuzzoUK COM, Department of Behavioral Science, Lexington, KY 40536, United States. Electronic address: pnuzz2@uky.edu.
Shanna BabalonisUniversity of Kentucky College of Medicine (UK COM), Center on Drug and Alcohol Research, 845 Angliana Ave., Lexington, KY 40508, United States; UK COM, Department of Behavioral Science, Lexington, KY 40536, United States. Electronic address: babalonis@uky.edu.
Samy Claude ElayiUK COM, Department of Cardiology, Gill Heart Institute, Lexington, KY 40536, United States. Electronic address: samy-claude.elayi@uky.edu.
Sharon L WalshUniversity of Kentucky College of Medicine (UK COM), Center on Drug and Alcohol Research, 845 Angliana Ave., Lexington, KY 40508, United States; UK COM, Department of Behavioral Science, Lexington, KY 40536, United States; UK COM, Department of Psychiatry, Lexington, KY 40509, United States. Electronic address: sharon.walsh@uky.edu.
University of Kentucky · USUniversity of Kentucky HealthCare · US

Funding

Kentucky Center for Clinical and Translational ScienceUL1TR000117 · NCATS · UNIVERSITY OF KENTUCKY · PI KERN, PHILIP A · 2012 to 2015
$13.3M
Kentucky Center for Clinical and Translational ScienceKL2TR000116 · NCATS · UNIVERSITY OF KENTUCKY · PI KERN, PHILIP A · 2012 to 2015
$1.9M
Evaluation of Novel Pharmacotherapies for the Treatment of Opioid DependenceR01DA033932 · NIDA · UNIVERSITY OF KENTUCKY · PI WALSH, SHARON L. · 2013 to 2014
$984k
NCATS NIH HHS KL2 TR000116NCATS NIH HHS TR000117NCATS NIH HHS UL1 TR000117NIDA NIH HHS DA033932NIDA NIH HHS R01 DA033932
6 · The paper itself

Abstract

backgroundOpioid dependence remains a significant public health problem worldwide with only three FDA-approved treatments, all targeting the mu-opioid receptor. Dronabinol, a cannabinoid (CB) 1 receptor agonist, is currently under investigation as a novel opioid withdrawal treatment. This study reports on safety outcomes of dronabinol among adults in opioid withdrawal.

methodsTwelve adults physically dependent on short-acting opioids participated in this 5-week within-subject, randomized, double blind, placebo-controlled inpatient study. Volunteers were maintained on oral oxycodone 30 mg qid. Double-blind placebo substitutions occurred for 21 h before each of 7 experimental sessions in order to produce opioid withdrawal. A single oral test dose was administered each session (placebo, oxycodone 30 and 60 mg, dronabinol 5, 10, 20, and 30 mg [decreased from 40 mg]). Heart rate, blood pressure, respiratory outcomes and pupil diameter were assessed repeatedly.

resultsDronabinol 40 mg produced sustained sinus tachycardia accompanied by anxiety and panic necessitating dose reduction to 30 mg. Sinus tachycardia and anxiety also occurred in one volunteer after dronabinol 20mg. Compared to placebo, dronabinol 20 and 30 mg produced significant increases in heart rate beginning 1h after drug administration that lasted approximately 2h (p<0.05). Dronabinol 5 and 10mg produced placebo-like effects. Oxycodone produced prototypic mu-opioid agonist effects (e.g., miosis).

conclusionDronabinol 20mg and higher increased heart rate among healthy adults at rest who were in a state of opioid withdrawal, raising concern about its safety. These results have important implications for future dosing strategies and may limit the utility of dronabinol as a treatment for opioid withdrawal.

Indexed as

Administration, OralAdolescentAdultAnalgesics, OpioidBlood PressureCannabinoid Receptor AgonistsDose-Response Relationship, DrugDouble-Blind MethodDronabinolFemaleHeart RateHumansMaleMiddle AgedOpioid-Related DisordersOxycodoneAnalgesics, OpioidCannabinoid Receptor AgonistsDronabinolOxycodoneDronabinolOpioid dependenceOpioid withdrawalSafetyTreatment

Identifiers

PMID26483357
PMCPMC4663169
OpenAlexW1875095310

What OpenQuestion holds

Textmetadata
LicenceTDM
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 OpenQuestion graph.