Evidence map›Paper›PMID 29776349›Full record

ArticleBMC psychiatry2018

Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: a study protocol.

Anjali K Bhardwaj, David J Allsop, Jan Copeland, Iain S McGregor, Adrian Dunlop, Marian Shanahan, Raimondo Bruno, Nghi Phung, Mark Montebello, Craig Sadler and 5 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
2.7field-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

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pharmacotherapies for cannabis use disorder.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Pharmacotherapies for cannabis dependence.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Trial
  5. Review
  6. THC and CBD: Villain versus Hero? Insights into Adolescent Exposure.International journal of molecular sciences · 2023
    Review
  7. Article
  8. Review
  9. Review
  10. 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

15 authors at 5 institutions in 1 country.

Anjali K BhardwajDiscipline of Addiction Medicine, Central Clinical School, University of Sydney, Sydney, NSW, Australia. anjali.bhardwaj@sydney.edu.au.
David J AllsopSchool of Psychology, University of Sydney, Sydney, NSW, Australia.
Jan CopelandNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.
Iain S McGregorSchool of Psychology, University of Sydney, Sydney, NSW, Australia.
Adrian DunlopDrug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle, NSW, Australia.
Marian ShanahanNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.
Raimondo BrunoNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.
Nghi PhungCentre for Addiction Medicine, Cumberland Hospital, Western Sydney Local Health District, Sydney, NSW, Australia.
Mark MontebelloThe Langton Centre, Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, NSW, Australia.
Craig SadlerDrug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle, NSW, Australia.
Jessica GugusheffDiscipline of Addiction Medicine, Central Clinical School, University of Sydney, Sydney, NSW, Australia.
Melissa JacksonDrug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle, NSW, Australia.
Jennifer LukszaCentre for Addiction Medicine, Cumberland Hospital, Western Sydney Local Health District, Sydney, NSW, Australia.
Nicholas LintzerisDiscipline of Addiction Medicine, Central Clinical School, University of Sydney, Sydney, NSW, Australia.
Agonist Replacement for Cannabis Dependence (ARCD) study group
The University of Sydney · AUSydney Local Health District · AUSouth Eastern Sydney Local Health District · AUUNSW Sydney · AUUniversity of Tasmania · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe cannabis extract nabiximols (Sativex®) effectively supresses withdrawal symptoms and cravings in treatment resistant cannabis dependent individuals, who have high relapse rates following conventional withdrawal treatments. This study examines the efficacy, safety and cost-effectiveness of longer-term nabiximols treatment for outpatient cannabis dependent patients who have not responded to previous conventional treatment approaches. METHODS/

designA phase III multi-site outpatient, randomised, double-blinded, placebo controlled parallel design, comparing a 12-week course of nabiximols to placebo, with follow up at 24 weeks after enrolment. Four specialist drug and alcohol outpatient clinics in New South Wales, Australia. One hundred forty-two treatment seeking cannabis dependent adults, with no significant medical, psychiatric or other substance use disorders. Nabiximols is an oromucosal spray prescribed on a flexible dose regimen to a maximum daily dose of 32 sprays; 8 sprays (total 21.6 mg tetrahydrocannabinol (THC) and 20 mg cannabidiol (CBD)) four times a day, or matching placebo, dispensed weekly. All participants will receive six-sessions of individual cognitive behavioural therapy (CBT) and weekly clinical reviews. Primary endpoints are use of non-prescribed cannabis (self-reported cannabis use days, urine toxicology), safety measures (adverse events and abuse liability), and cost effectiveness (incremental cost effectiveness in achieving additional Quality Adjusted Life Years). Secondary outcomes include, improvement in physical and mental health parameters, substance use other than cannabis, cognitive functioning and patient satisfaction measures. DISCUSSION: This is the first outpatient community-based randomised controlled study of nabiximols as an agonist replacement medication for treating cannabis dependence, targeting individuals who have not previously responded to conventional treatment approaches. The study and treatment design is modelled upon an earlier study with this population and more generally on other agonist replacement treatments (e.g. nicotine, opioids).

trial registrationAustralian and New Zealand Clinical Trial Registry: ACTRN12616000103460 (Registered 1st February 2016).

Indexed as

AdultAustraliaCannabidiolCannabinoidsCognitionCognitive Behavioral TherapyCombined Modality TherapyCravingDouble-Blind MethodDronabinolDrug CombinationsFemaleHumansMaleMarijuana AbuseNew South WalesCannabidiolCannabinoidsDronabinolDrug CombinationsnabiximolsAgonist replacementCannabisCannabis withdrawalMarijuanaNabiximolsStudy protocol

Identifiers

PMID29776349
PMCPMC5960200
OpenAlexW2807456978

What OpenQuestion 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 OpenQuestion graph.