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Psychopathological and cognitive effects of therapeutic cannabinoids in multiple sclerosis: a double-blind, placebo controlled, crossover study.

Abstract

OBJECTIVES

To study possible psychopathological symptoms and cognitive deficits, abuse induction, as well as general tolerability and effects on quality of life, fatigue and motor function in cannabis-naïve patients with multiple sclerosis (MS) treated with a free-dose cannabis plant extract (Sativex).

METHODS

In an 8-week, randomized, double-blind, placebo-controlled, parallel group crossover trial, 17 cannabis-naïve patients with MS were assessed at baseline and at the end of the cannabis and placebo phases of the trial (each of 3 weeks) by means of Symptom Checklist-90 Revised, Self-rating Anxiety Scale, Multiple Sclerosis Functional Composite (of which 1 dimension is the Paced Auditory Serial Additional Test that was used to evaluate cognition), Visual Analogue Scale on health-related quality of life, Multiple Sclerosis Impact Scale-29, and Fatigue Severity Scale.

RESULTS

Postplacebo versus postcannabinoid scores showed that no significant differences could be detected on all the variables under study. A significant positive correlation was found between Delta-9-tetrahydrocannabinol blood levels and scores at the General Symptomatic Index and at the "interpersonal sensitivity," "aggressive behaviour," and "paranoiac tendencies" subscales of the Symptom Checklist-90 Revised. No serious adverse events, abuse tendencies, or direct withdrawal symptoms were reported. Increased desire for Sativex with secondary depression was reported in 1 subject.

CONCLUSIONS

Cannabinoid treatment did not induce psychopathology and did not impair cognition in cannabis-naïve patients with MS. However, the positive correlation between blood levels of Delta-9-tetrahydrocannabinol and psychopathological scores suggests that at dosages higher than those used in therapeutic settings, interpersonal sensitivity, aggressiveness, and paranoiac features might arise, although greater statistical power would be necessary to confirm this finding.

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  • Authors+Show Affiliations

    ,

    "Sapienza" University, Rome, Italy.

    , , , , , , ,

    Source

    MeSH

    Adult
    Cannabidiol
    Cannabinoids
    Cognition Disorders
    Cross-Over Studies
    Disability Evaluation
    Double-Blind Method
    Dronabinol
    Female
    Humans
    Male
    Middle Aged
    Multiple Sclerosis
    Neuropsychological Tests
    Psychiatric Status Rating Scales
    Statistics as Topic
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    18978501

    Citation

    Aragona, Massimiliano, et al. "Psychopathological and Cognitive Effects of Therapeutic Cannabinoids in Multiple Sclerosis: a Double-blind, Placebo Controlled, Crossover Study." Clinical Neuropharmacology, vol. 32, no. 1, 2009, pp. 41-7.
    Aragona M, Onesti E, Tomassini V, et al. Psychopathological and cognitive effects of therapeutic cannabinoids in multiple sclerosis: a double-blind, placebo controlled, crossover study. Clin Neuropharmacol. 2009;32(1):41-7.
    Aragona, M., Onesti, E., Tomassini, V., Conte, A., Gupta, S., Gilio, F., ... Inghilleri, M. (2009). Psychopathological and cognitive effects of therapeutic cannabinoids in multiple sclerosis: a double-blind, placebo controlled, crossover study. Clinical Neuropharmacology, 32(1), pp. 41-7. doi:10.1097/WNF.0B013E3181633497.
    Aragona M, et al. Psychopathological and Cognitive Effects of Therapeutic Cannabinoids in Multiple Sclerosis: a Double-blind, Placebo Controlled, Crossover Study. Clin Neuropharmacol. 2009;32(1):41-7. PubMed PMID: 18978501.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Psychopathological and cognitive effects of therapeutic cannabinoids in multiple sclerosis: a double-blind, placebo controlled, crossover study. AU - Aragona,Massimiliano, AU - Onesti,Emanuela, AU - Tomassini,Valentina, AU - Conte,Antonella, AU - Gupta,Shiva, AU - Gilio,Francesca, AU - Pantano,Patrizia, AU - Pozzilli,Carlo, AU - Inghilleri,Maurizio, PY - 2008/11/4/pubmed PY - 2009/9/3/medline PY - 2008/11/4/entrez SP - 41 EP - 7 JF - Clinical neuropharmacology JO - Clin Neuropharmacol VL - 32 IS - 1 N2 - OBJECTIVES: To study possible psychopathological symptoms and cognitive deficits, abuse induction, as well as general tolerability and effects on quality of life, fatigue and motor function in cannabis-naïve patients with multiple sclerosis (MS) treated with a free-dose cannabis plant extract (Sativex). METHODS: In an 8-week, randomized, double-blind, placebo-controlled, parallel group crossover trial, 17 cannabis-naïve patients with MS were assessed at baseline and at the end of the cannabis and placebo phases of the trial (each of 3 weeks) by means of Symptom Checklist-90 Revised, Self-rating Anxiety Scale, Multiple Sclerosis Functional Composite (of which 1 dimension is the Paced Auditory Serial Additional Test that was used to evaluate cognition), Visual Analogue Scale on health-related quality of life, Multiple Sclerosis Impact Scale-29, and Fatigue Severity Scale. RESULTS: Postplacebo versus postcannabinoid scores showed that no significant differences could be detected on all the variables under study. A significant positive correlation was found between Delta-9-tetrahydrocannabinol blood levels and scores at the General Symptomatic Index and at the "interpersonal sensitivity," "aggressive behaviour," and "paranoiac tendencies" subscales of the Symptom Checklist-90 Revised. No serious adverse events, abuse tendencies, or direct withdrawal symptoms were reported. Increased desire for Sativex with secondary depression was reported in 1 subject. CONCLUSIONS: Cannabinoid treatment did not induce psychopathology and did not impair cognition in cannabis-naïve patients with MS. However, the positive correlation between blood levels of Delta-9-tetrahydrocannabinol and psychopathological scores suggests that at dosages higher than those used in therapeutic settings, interpersonal sensitivity, aggressiveness, and paranoiac features might arise, although greater statistical power would be necessary to confirm this finding. SN - 1537-162X UR - https://www.unboundmedicine.com/medline/citation/18978501/Psychopathological_and_cognitive_effects_of_therapeutic_cannabinoids_in_multiple_sclerosis:_a_double_blind_placebo_controlled_crossover_study_ L2 - http://Insights.ovid.com/pubmed?pmid=18978501 DB - PRIME DP - Unbound Medicine ER -