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

Abstract The 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.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title plos one
Publication Year Start




PMID- 29385147
OWN - NLM
STAT- In-Process
LR  - 20180131
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 13
IP  - 1
DP  - 2018
TI  - Nabiximols combined with motivational enhancement/cognitive behavioral therapy
      for the treatment of cannabis dependence: A pilot randomized clinical trial.
PG  - e0190768
LID - 10.1371/journal.pone.0190768 [doi]
AB  - BACKGROUND: The 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
      Delta9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex(R)) 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. METHODS: Subjects 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. RESULTS:
      Medication 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. CONCLUSIONS: Nabiximols 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.
FAU - Trigo, Jose M
AU  - Trigo JM
AD  - Translational Addiction Research Laboratory, Campbell Family Mental Health
      Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto,
      Canada.
FAU - Soliman, Alexandra
AU  - Soliman A
AD  - Translational Addiction Research Laboratory, Campbell Family Mental Health
      Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto,
      Canada.
FAU - Quilty, Lena C
AU  - Quilty LC
AD  - Campbell Family Mental Health Research Institute, CAMH, Toronto, Canada.
AD  - Department of Psychiatry, University of Toronto, Toronto, Canada.
FAU - Fischer, Benedikt
AU  - Fischer B
AD  - Department of Psychiatry, University of Toronto, Toronto, Canada.
AD  - Institute of Medical Science, University of Toronto, Faculty of Medicine,
      Toronto, Canada.
AD  - Institute for Mental Health Policy Research, CAMH, Toronto, Canada.
AD  - Centre for Applied Research in Mental Health & Addiction, Faculty of Health
      Sciences, Simon Fraser University, Vancouver, Canada.
FAU - Rehm, Jurgen
AU  - Rehm J
AD  - Department of Psychiatry, University of Toronto, Toronto, Canada.
AD  - Institute of Medical Science, University of Toronto, Faculty of Medicine,
      Toronto, Canada.
AD  - Institute for Mental Health Policy Research, CAMH, Toronto, Canada.
AD  - Addiction Policy, Dalla Lana School of Public Health, University of Toronto,
      Toronto, Canada.
AD  - Institute of Clinical Psychology and Psychotherapy & Center of Clinical
      Epidemiology and Longitudinal Studies (CELOS), Technische Universitat Dresden,
      Dresden, Germany.
FAU - Selby, Peter
AU  - Selby P
AD  - Department of Psychiatry, University of Toronto, Toronto, Canada.
AD  - Addictions Division, CAMH, Toronto, Canada.
AD  - Department of Family and Community Medicine, University of Toronto, Toronto,
      Canada.
FAU - Barnes, Allan J
AU  - Barnes AJ
AD  - Chemistry and Drug Metabolism, National Institute on Drug Abuse (NIDA), National 
      Institutes of Health (NIH), Baltimore, United States of America.
FAU - Huestis, Marilyn A
AU  - Huestis MA
AD  - Chemistry and Drug Metabolism, National Institute on Drug Abuse (NIDA), National 
      Institutes of Health (NIH), Baltimore, United States of America.
FAU - George, Tony P
AU  - George TP
AD  - Department of Psychiatry, University of Toronto, Toronto, Canada.
AD  - Addictions Division, CAMH, Toronto, Canada.
AD  - Division of Brain and Therapeutics, CAMH, Toronto, Canada.
FAU - Streiner, David L
AU  - Streiner DL
AD  - Department of Psychiatry, University of Toronto, Toronto, Canada.
AD  - Department of Psychiatry & Behavioural Neurosciences, McMaster University,
      Hamilton, Canada.
FAU - Staios, Gregory
AU  - Staios G
AD  - Translational Addiction Research Laboratory, Campbell Family Mental Health
      Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto,
      Canada.
FAU - Le Foll, Bernard
AU  - Le Foll B
AUID- ORCID: 0000-0002-6406-4973
AD  - Translational Addiction Research Laboratory, Campbell Family Mental Health
      Research Institute, Centre for Addiction and Mental Health (CAMH), Toronto,
      Canada.
AD  - Addictions Division, CAMH, Toronto, Canada.
LA  - eng
GR  - R21DA031906 /NH/NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20180131
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
EDAT- 2018/02/01 06:00
MHDA- 2018/02/01 06:00
CRDT- 2018/02/01 06:00
PHST- 2017/05/12 00:00 [received]
PHST- 2017/12/12 00:00 [accepted]
PHST- 2018/02/01 06:00 [entrez]
PHST- 2018/02/01 06:00 [pubmed]
PHST- 2018/02/01 06:00 [medline]
AID - 10.1371/journal.pone.0190768 [doi]
AID - PONE-D-17-17894 [pii]
PST - epublish
SO  - PLoS One. 2018 Jan 31;13(1):e0190768. doi: 10.1371/journal.pone.0190768.
      eCollection 2018.