Canna~Fangled Abstracts

Clinical Trials of Cannabidiol for Substance Use Disorders: Outcome Measures, Surrogate Endpoints, and Biomarkers

By February 22, 2021March 16th, 2021No Comments
The outcome measures and biomarkers assessed in the ongoing CBD trials for substance use disorders are improving.
Review
. 2021 Feb 22;12:565617.

doi: 10.3389/fpsyt.2021.565617. eCollection 2021.

Alix Morel 1, Pierre Lebard 1, Alexandra Dereux 1 2 3, Julien Azuar 1 2 3, Frank Questel 1 2 3, Frank Bellivier 1 2 3 4, Cynthia Marie-Claire 2 3, Mélina Fatséas 5 6 7, Florence Vorspan 1 2 3 4, Vanessa Bloch 2 3 8
Affiliations 

Free PMC article

Abstract

Background: Cannabidiol (CBD) is a cannabinoid of potential interest for the treatment of substance use disorders. Our aim was to review the outcome measures, surrogate endpoints, and biomarkers in published and ongoing randomized clinical trials.

Methods: We conducted a search in PubMed, Web of Science, PMC, PsycINFO, EMBASE, CENTRAL Cochrane Library, “clinicalTrials.gov,” “clinicaltrialsregister.eu,” and “anzctr.org.au” for published and ongoing studies. Inclusion criteria were randomized clinical trials (RCTs) examining the use of CBD alone or in association with other cannabinoids, in all substance use disorders. The included studies were analyzed in detail and their qualities assessed by a standardized tool (CONSORT 2010). A short description of excluded studies, consisting in controlled short-term or single administration in non-treatment-seeking drug users, is provided.

Findings: The screening retrieved 207 published studies, including only 3 RCTs in cannabis use disorder. Furthermore, 12 excluded studies in cannabis, tobacco, and opioid use disorders are described.

Interpretation: Primary outcomes were validated withdrawal symptoms scales and drug use reduction in the three RCTs. In the short-term or crossover studies, the outcome measures were visual analog scales for subjective states; self-rated scales for withdrawal, craving, anxiety, or psychotomimetic symptoms; and laboratory tasks of drug-induced craving, effort expenditure, attentional bias for substance, impulsivity, or anxiety to serve as surrogate endpoints for treatment efficacy. Of note, ongoing studies are now adding peripheral biomarkers of the endocannabinoid system status to predict treatment response.

Conclusion: The outcome measures and biomarkers assessed in the ongoing CBD trials for substance use disorders are improving.

 

Keywords: biomarker, cannabidiol, cannabinoids, cannabis, clinical trials, efficacy, opioid, tobacco

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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