Background
Endocannabinoid dysfunction in animal models of autism spectrum disorder (ASD) and accumulating, albeit anecdotal, evidence for efficacy in humans motivated this placebo-controlled double-blind comparison of two oral cannabinoid solutions in 150 participants (age 5–21 years) with ASD.
Methods
We tested (1) BOL-DP-O-01-W, a whole-plant cannabis extract containing cannabidiol and Δ9-tetrahydrocannabinol at a 20:1 ratio and (2) BOL-DP-O-01, purified cannabidiol and Δ9-tetrahydrocannabinol at the same ratio. Participants (N = 150) received either placebo or cannabinoids for 12-weeks (testing efficacy) followed by a 4-week washout and predetermined cross-over for another 12 weeks to further assess tolerability.
Registered primary efficacy outcome measures were improvement in behavioral problems (differences between whole-plant extract and placebo) on the Home Situation Questionnaire-ASD (HSQ-ASD) and the Clinical Global Impression-Improvement scale with disruptive behavior anchor points (CGI-I). Secondary measures were Social Responsiveness Scale (SRS-2) and Autism Parenting Stress Index (APSI).
Results
Changes in Total Scores of HSQ-ASD (primary-outcome) and APSI (secondary-outcome) did not differ among groups. Disruptive behavior on the CGI-I (co-primary outcome) was either much or very much improved in 49% on whole-plant extract (n = 45) versus 21% on placebo (n = 47; p = 0.005). Median SRS Total Score (secondary-outcome) improved by 14.9 on whole-plant extract (n = 34) versus 3.6 points after placebo (n = 36); p = 0.009). There were no treatment-related serious adverse events. Common adverse events included somnolence and decreased appetite, reported for 28% and 25% on whole-plant extract, respectively (n = 95); 23% and 21% on pure-cannabinoids (n = 93), and 8% and 15% on placebo (n = 94).
Limitations
Lack of pharmacokinetic data and a wide range of ages and functional levels among participants warrant caution when interpreting the results.
Conclusions
This interventional study provides evidence that BOL-DP-O-01-W and BOL-DP-O-01, administrated for 3 months, are well tolerated. Evidence for efficacy of these interventions are mixed and insufficient. Further testing of cannabinoids in ASD is recommended.
Trial registration ClinicalTrials.gov: NCT02956226. Registered 06 November 2016, https://clinicaltrials.gov/ct2/show/NCT02956226
This article explores the practices, discourses and dilemmas of the Israeli human rights NGOs that are working to protect and promote the human rights of Palestinians in the Occupied Territories. This case can shed light on the complex process of “triangular translation” of human rights, which is distinct from other forms of human rights localization studied thus far. In this process, human rights NGOs translate international human rights norms on the one hand, and the suffering of the victims on the other, into the conceptions and legal language commonly employed by the state that violates these rights. We analyze the dialectics of change and reproduction embedded in the efforts of Israeli activists to defend Palestinian human rights while at the same time depoliticizing their work and adopting discriminatory premises and conceptions hegemonic in Israeli society. The recent and alarming legislative proposals in Israel aimed at curtailing the work of human rights NGOs reinforce the need to reconsider the role of human rights NGOs in society, including their depoliticized strategies, their use of legal language and their relations with the diminishing peace movement.
The current study was designed to explore the delayed effect of participating in youth mentoring programs, training in civic engagement, and activism on a sample of 337 Israelis 5 to 10 years after serving as student mentors. Qualitative and quantitative findings showed that these former mentors' perception of the contribution of mentoring was correlated with their current civic engagement attitudes and activism. Further, the perceived quality of training during mentoring was correlated with the overall perceived contribution of mentoring and current civic engagement attitudes. A mediation model showed that the perceived quality of training was correlated with the former mentors' perceived mentoring contribution. This in turn was correlated with current civic engagement attitudes, which themselves were correlated with their current civic engagement activism. The former mentors' narratives revealed their attainment of new skills and abilities, including an increased ability to relate to and understand young children and disadvantaged populations.
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