Evidence map›Paper›PMID 27234658›Full record

Trial reportDrug and alcohol dependence2016

Opioid withdrawal suppression efficacy of oral dronabinol in opioid dependent humans.

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

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07148206 (Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial), which is not on this map. Cited by 41 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 6 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT07148206 phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial

TypeinterventionalSponsorMontefiore Medical CenterRan2026 to 2028Enrolled40ConditionsOpioid Use DisorderArmsDronabinol Capsules, Epidiolex 100 mg/mL Oral Solution, Placebo Dronabinol, Placebo Epidiolex
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 6 syntheses or guidelines pooled it, 63 citations in OpenAlex.

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  9. Ten-year outcomes of medical cannabis for chronic low back pain: opioid reduction, pain relief, and functional improvement in 1,000 patients.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
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  14. Effects of ΔThe Journal of pharmacology and experimental therapeutics · 2025
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  20. ΔJournal of clinical medicine · 2024
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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

5 authors at 2 institutions in 1 country.

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.
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.
Paul A NuzzoUK COM, Department of Behavioral Science, Lexington, KY 40536, United States.
Samy Claude ElayiUK COM, Department of Cardiology, Gill Heart Institute, Lexington, KY 40536, United States.
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: michelle.lofwall@uky.edu.
University of Kentucky HealthCare · USUniversity of Kentucky · 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 UL1 TR000117NIDA NIH HHS R01 DA033932
6 · The paper itself

Abstract

backgroundThe cannabinoid (CB) system is a rational novel target for treating opioid dependence, a significant public health problem around the world. This proof-of-concept study examined the potential efficacy of a CB1 receptor partial agonist, dronabinol, in relieving signs and symptoms of opioid withdrawal.

methodsTwelve opioid dependent adults participated in this 5-week, inpatient, double-blind, randomized, placebo-controlled study. Volunteers were maintained on double-blind oxycodone (30mg oral, four times/day) and participated in a training session followed by 7 experimental sessions, each testing a single oral test dose (placebo, oxycodone 30 and 60mg, dronabinol 5, 10, 20, and 30mg [decreased from 40mg]). Placebo was substituted for oxycodone maintenance doses for 21h before each session in order to produce measurable opioid withdrawal. Outcomes included observer- and participant-ratings of opioid agonist, opioid withdrawal and psychomotor/cognitive performance.

resultsOxycodone produced prototypic opioid agonist effects (i.e. suppressing withdrawal and increasing subjective effects indicative of abuse liability). Dronabinol 5 and 10mg produced effects most similar to placebo, while the 20 and 30mg doses produced modest signals of withdrawal suppression that were accompanied by dose-related increases in high, sedation, bad effects, feelings of heart racing, and tachycardia. Dronabinol was not liked more than placebo, showed some impairment in cognitive performance, and was identified as marijuana with increasing dose.

conclusionCB1 receptor activation is a reasonable strategy to pursue for the treatment of opioid withdrawal; however, dronabinol is not a likely candidate given its modest withdrawal suppression effects of limited duration and previously reported tachycardia during opioid withdrawal.

Indexed as

Administration, OralAdultAnalgesics, Non-NarcoticAnalgesics, OpioidDose-Response Relationship, DrugDouble-Blind MethodDronabinolFemaleHumansMaleMiddle AgedOpiate Substitution TreatmentOpioid-Related DisordersOxycodoneReceptor, Cannabinoid, CB1Substance Withdrawal SyndromeAnalgesics, Non-NarcoticAnalgesics, OpioidDronabinolOxycodoneReceptor, Cannabinoid, CB1Abuse liabilityDronabinolOpioid withdrawalTreatment

Identifiers

PMID27234658
PMCPMC4910823
OpenAlexW2392691276

What OpenQuestion holds

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Read underepoch 390

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.