Evidence map›Paper›PMID 29385147›Full record

Trial reportPloS one2018

Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

Jose M Trigo, Alexandra Soliman, Lena C Quilty, Benedikt Fischer, Jürgen Rehm, Peter Selby, Allan J Barnes, Marilyn A Huestis, Tony P George, David L Streiner and 2 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 11 pooled it
10.2field-weighted citation impact, top 1% 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

53 citing papers in PubMed, 11 syntheses or guidelines pooled it, 117 citations in OpenAlex.

  1. Guideline
  2. Pharmacotherapies for cannabis use disorder.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Pooled it
  4. Multinational Association of Supportive Care in Cancer (MASCC) guidelines: cannabis for psychological symptoms including insomnia, anxiety, and depression.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pharmacotherapies for cannabis dependence.The Cochrane database of systematic reviews · 2019
    Pooled it
  11. Pooled it
  12. Trial
  13. Trial
  14. Trial
  15. Review
  16. Article
  17. Cannabidiol alleviates methamphetamine addictionActa pharmaceutica Sinica. B · 2025
    Article
  18. Cannabis use disorder: from neurobiology to treatment.The Journal of clinical investigation · 2024
    Review
  19. Review
  20. The Use of Compounds Derived fromInternational journal of molecular sciences · 2024
    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

12 authors at 4 institutions in 3 countries.

Jose M TrigoTranslational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada.
Alexandra SolimanTranslational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada.
Lena C QuiltyCampbell Family Mental Health Research Institute, CAMH, Toronto, Canada.
Benedikt FischerDepartment of Psychiatry, University of Toronto, Toronto, Canada.
Jürgen RehmDepartment of Psychiatry, University of Toronto, Toronto, Canada.
Peter SelbyDepartment of Psychiatry, University of Toronto, Toronto, Canada.
Allan J BarnesChemistry and Drug Metabolism, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Baltimore, United States of America.
Marilyn A HuestisChemistry and Drug Metabolism, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Baltimore, United States of America.
Tony P GeorgeDepartment of Psychiatry, University of Toronto, Toronto, Canada.
David L StreinerDepartment of Psychiatry, University of Toronto, Toronto, Canada.
Gregory StaiosTranslational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada.
Bernard Le FollTranslational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada.ORCID 0000-0002-6406-4973
Centre for Addiction and Mental Health · CAUniversity of Toronto · CANational Institutes of Health · USSimon Fraser University · CA

Funding

Sativex associated with behavioural-relapse prevention strategy as treatment for cannabis dependenceR21DA031906 · NIDA · CENTRE FOR ADDICTION AND MENTAL HEALTH · PI LE FOLL, BERNARD · 2011 to 2016
$334k
NIDA NIH HHS R21 DA031906NIH HHS R21DA031906
6 · The paper itself

Abstract

backgroundThe current lack of pharmacological treatments for cannabis use disorder (CUD) warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex®) can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants.

methodsSubjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time.

resultsMedication was well tolerated and no serious adverse events (SAEs) were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS). There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS). Cannabis use was reduced in the nabiximols (70.5%) and placebo groups (42.6%). Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores.

conclusionsNabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

Indexed as

Cognitive Behavioral TherapyMotivationAdultCannabidiolCravingDouble-Blind MethodDronabinolDrug CombinationsFemaleHumansMaleMarijuana AbuseMiddle AgedPilot ProjectsPlacebosSubstance Withdrawal SyndromeCannabidiolDronabinolDrug CombinationsnabiximolsPlacebos

Identifiers

PMID29385147
PMCPMC5791962
OpenAlexW2789276845

What OpenQuestion holds

Textmetadata
LicenceCC0
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.