Evidence map›Paper›PMID 26925704›Full record

Trial reportDrug and alcohol dependence2016

Effects of fixed or self-titrated dosages of Sativex on cannabis withdrawal and cravings.

Jose M Trigo, Dina Lagzdins, Jürgen Rehm, Peter Selby, Islam Gamaleddin, Benedikt Fischer, Allan J Barnes, Marilyn A Huestis, Bernard Le Foll

Open 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. Cited by 43 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 5 pooled it
10.7field-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

43 citing papers in PubMed, 5 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pharmacotherapies for cannabis dependence.The Cochrane database of systematic reviews · 2019
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Pharmacotherapy for Cannabis Use Disorder: Preclinical and Clinical Models.Current topics in behavioral neurosciences · 2026
    Review
  11. Cannabis use disorder: from neurobiology to treatment.The Journal of clinical investigation · 2024
    Review
  12. Review
  13. Review
  14. Cannabis and Pregnancy: A Review.Obstetrical & gynecological survey · 2023
    Review
  15. THC and CBD: Villain versus Hero? Insights into Adolescent Exposure.International journal of molecular sciences · 2023
    Review
  16. Article
  17. Article
  18. Article
  19. Monitoring the impact of cannabis use.Trends in psychiatry and psychotherapy · 2022
    Article
  20. Clinical management of cannabis withdrawal.Addiction (Abingdon, England) · 2022
    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

9 authors at 3 institutions in 4 countries.

Jose M TrigoTranslational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada.
Dina LagzdinsTranslational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada.
Jürgen RehmSocial and Epidemiological Research Department, CAMH, Toronto, Canada; Addiction Policy, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada; Institute of Medical Science, University of Toronto, Faculty of Medicine, Toronto, Canada; Department of Psychiatry, University of Toronto, Canada; Institute of Clinical Psychology and Psychotherapy & Center of Clinical Epidemiology and Longitudinal Studies (CELOS), Technische Universität Dresden, Dresden, Germany.
Peter SelbyDepartment of Psychiatry, University of Toronto, Canada; Addictions Division, CAMH, Toronto, Canada; Department of Family and Community Medicine, University of Toronto, Canada.
Islam GamaleddinTranslational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada; Department of Medical Sciences, Institute of Environmental Studies and Research, Ain Shams University, Cairo, Egypt; Directorate of Poison Control Centres, MOH, Riyadh, Saudi Arabia.
Benedikt FischerSocial and Epidemiological Research Department, CAMH, Toronto, Canada; Department of Psychiatry, University of Toronto, Canada; Centre for Applied Research in Mental Health & Addiction, Faculty of Health Sciences, Simon Fraser University, Vancouver, Canada.
Allan J BarnesChemistry and Drug Metabolism, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Baltimore, USA.
Marilyn A HuestisChemistry and Drug Metabolism, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Baltimore, USA.
Bernard Le FollTranslational Addiction Research Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto, Canada; Addictions Division, CAMH, Toronto, Canada. Electronic address: bernard.lefoll@camh.ca.
Centre for Addiction and Mental Health · CANational Institutes of Health · USAin Shams University · EG

Funding

CIHR 115548-1
6 · The paper itself

Abstract

backgroundThere is currently no pharmacological treatment approved for cannabis dependence. In this proof of concept study, we assessed the feasibility/effects of fixed and self-titrated dosages of Sativex (1:1, Δ(9)-tetrahydrocannabinol (THC)/cannabidiol (CBD)) on craving and withdrawal from cannabis among nine community-recruited cannabis-dependent subjects.

methodsParticipants underwent an 8-week double-blind placebo-controlled trial (an ABACADAE design), with four smoke as usual conditions (SAU) (A) separated by four cannabis abstinence conditions (B-E), with administration of either self-titrated/fixed doses of placebo or Sativex (up to 108 mg THC/100 mg CBD). The order of medication administration during abstinence conditions was randomized and counterbalanced. Withdrawal symptoms and craving were assessed using the Cannabis Withdrawal Scale (CWS), Marijuana Withdrawal Checklist (MWC) and Marijuana Craving Questionnaire (MCQ). Medication use was assessed during the study by means of self-reports, vial weight control, toxicology and metabolite analysis. Cannabis use was assessed by means of self-reports.

resultsHigh fixed doses of Sativex were well tolerated and significantly reduced cannabis withdrawal during abstinence, but not craving, as compared to placebo. Self-titrated doses were lower and showed limited efficacy as compared to high fixed doses. Participants reported a significantly lower "high" following Sativex or placebo as compared to SAU conditions. Cannabis/medication use along the study, as per self-reports, suggests compliance with the study conditions.

conclusionsThe results found in this proof of concept study warrant further systematic exploration of Sativex as a treatment option for cannabis withdrawal and dependence.

Indexed as

AdultCannabidiolCannabisCravingDouble-Blind MethodDronabinolDrug CombinationsFemaleHumansMaleMarijuana AbuseMarijuana SmokingMiddle AgedPlant ExtractsSubstance-Related DisordersSubstance Withdrawal SyndromeCannabidiolDronabinolDrug CombinationsnabiximolsPlant ExtractsCannabidiolCannabisClinical trials.gov ID# NCT01748799MarijuanaTHCWithdrawal

Identifiers

PMID26925704
PMCPMC4878903
OpenAlexW2276226615

What OpenQuestion holds

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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.