Evaluation of the effects of CBD hemp extract on opioid use and quality of life indicators in chronic pain patients : a prospective cohort study

Alex Capano, Richard Weaver & Elisa Burkman

Postgraduate Medicine, 2019,

© 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Doi : 10.1080/00325481.2019.1685298

 

ABSTRACT

Context : Chronic pain is highly prevalent in most of the industrialized nations around the world. Despite the documented adverse effects, opioids are widely used for pain management. Cannabinoids, and specifically Cannabidiol, is proposed as an opioid alternative, having comparable efficacy with better safety profile.

Objectives : We aim to investigate the impact of full hemp extract cannabidiol (CBD) on opioid use and quality of life indicators among chronic pain patients.

Methods : An initial sample of 131 patients was recruited from a private pain management center’s investigative population. Ninety-seven patients completed the 8-week study. The primary inclusion criteria included patients between 30 and 65 years old with chronic pain who have been on opioids for at least 1 year. Data were collected at three different time points: baseline, 4, and 8 weeks. Opioid and other medication use were evaluated via the medication and psychiatric treatment receipt. Improvement was evaluated using four indices: Pain Disability Index (PDI-4); Pittsburgh Sleep Quality Index (PSQI), Pain Intensity and Interference (PEG); and Patient Health Questionnaire (PHQ-4).

Results : Over half of chronic pain patients (53%) reduced or eliminated their opioids within 8 weeks
after adding CBD-rich hemp extract to their regimens. Almost all CBD users (94%) reported quality of life improvements. The results indicated a significant relationship between CBD and PSQI (p = 0.003), and PEG (p = 0.006). There was a trend toward improvement but no significant relationship between CBD use and PHQ and PDI.

Conclusion : CBD could significantly reduce opioid use and improve chronic pain and sleep quality
among patients who are currently using opioids for pain management.

Key Message : This is a prospective, single-arm cohort study for the potential role of cannabinoids as an alternative for opioids. The results indicate that using the CBD-rich extract enabled our patients to
reduce or eliminate opioids with significant improvement in their quality of life indices.

KEYWORDS : Cannabinoid; chronic pain; opioids; cannabidiol; sleep; cannabis

 

Introduction

Chronic pain is a major cause of disability worldwide with a prevalence rate of 15% to 30% in the general adult population, and more than 500 billion dollars annual costs in the United States. Unfortunately, multiple reports are showing a lack of satisfactory results with available pharmacotherapy with less than 70% of patients having pain relief [1]. Currently, opioids are the mainstay for pain control for most cases
including, neuropathic and cancer pain. Nonetheless, the inherent adverse events of opioids are representing major concerns [2]. All too often, these patients become dependent on opioid medications, which carry a risk of tolerance and subsequent physical dependence and multiple adverse effects such as somnolence and constipation, and the potential of death from an overdose [3,4]. Therefore, enormous efforts are exerted to find additional approaches and to provide alternative options with a better safety profile and comparable efficacy.

Cannabis, the plant source of cannabinoids (CB), have been used for millennia for different purposes such as pain control and stress relief. Recently, the delineation of the endocannabinoid system and CB receptors in humans has paved the road for broader applications [5]. Their natural source and the widespread use besides its lower risk of addiction or dependency and relative safety have flagged them for in-depth investigation for potential therapeutic roles. Two molecules have been of high-interest : cannabidiol (CBD) and tetrahydrocannabidiol (THC) [6].

Recent evidence highlights cannabinoids’ efficacy and safety for pain control. Whiting et al. analyzed 28 clinical trials evaluating cannabinoids in pain control, concluding that there is a moderate-quality evidence that cannabinoids may result in marked pain reduction [7]. This was consistent with its effect on neuropathic pain where cannabinoids were effective in pain relief [8,9]. National Academies of Science, Engineering, and Medicine conducted an extensive systematic review to evaluate cannabinoids, stating that there is ‘extensive evidence’ of cannabinoids’ efficacy in pain relief with good tolerability [10].

Besides its potential direct effects on pain, cannabinoids are suggested to have a role in reducing opioid intake [11,12]. A recent report has highlighted the lower mortality from opioids’ overdose in states with medical cannabis legalization. Similarly, Medicare prescriptions’ reports revealed reduced opioids’ use and their consequent adverse events in the United States (U.S.) with legalized cannabis access [13]. In
addition, cannabinoids use may mitigate the escalation of opioid doses in patients with chronic pain with a substantial reduction in opioid intake [14].

The above studies reference the effects of both THC and CBD, the two most abundant and frequently used cannabinoids. THC is a psychogenic molecule responsible for eliciting a ‘high’ sought out in recreational marijuana use. CBD is not intoxicating and therefore possesses an arguably better safety profile than THC [15–17]. Because of these differences in intoxication and abuse potential, the THC and CBD experience varying regulatory paths. Despite increasing state-level legalization, cannabis plants with higher levels (>0.3%) of THC are considered ‘marijuana’ and are federally illegal in the U.S [18]. Low THC (<0.3%) cannabis plants, known as hemp, and its extracts have been recently deemed federally legal in the U.S. via pilot programs in Section 7606 of the 2014 Farm Bill, subsequently made permanent via the 2018 Farm Bill [19–21]. Therefore, hemp-derived cannabis extracts, low in THC and high in CBD, have become increasingly available as over-thecounter products and subject to widespread consumer use across diverse populations [22].

Aiming to control the opioid epidemic, CBD has been investigated for its potential to reduce the addiction risk and physiological dependence features of opioid use while subsequently managing pain [23]. Preclinical models demonstrate CBD’s ability to decrease relapse risk by reducing opioid seeking behavior [24]. Early human trials confirm CBD’s potential in reducing opioid withdrawal symptoms [25]. A recent survey study concluded that 44% of hemp CBD users reported it helped reduce the use of their opioid pain medication [25].

CBD was found to reduce the craving, anxiety and psychological manifestations significantly in drug-abstinent individuals with previous opioid dependency [26,27]. Emerging literature supports evidence for CBD in pain relief and opioid reduction, but no studies to date have evaluated the effects of readily available hemp CBD in chronic pain and opioid use in a single cohort.

In the present study, we aim at investigating the impact of hemp CBD use on opioid use in chronic pain, disability, physical and psychosocial symptoms, sleep, and motivation to taper opioids. We believe that such a study will fill the existing gap and highlight potentially applicable roles for CBD therapeutic indications.

Methods

Study design and ethical considerations

Our study is a prospective, single-arm cohort study that was carried out at Murphy Pain Center, U.S. The study was granted an Institutional Review Board approval from Advarra. All study procedures were conducted in accordance with the declaration of Helsinki. In addition, all enrolled participants had to sign an IRB approved informed consent form at a standard of care visit. For confidentiality, all participants’ data have been coded and stored separately from participants’ identifiers and contact information. The crosswalk between the study ID and participant identifiers has been stored separately from participant data in a password-protected file within a password protected folder on a secure server system.

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Evaluation of the effects of CBD hemp extract on opioid use and quality of life indicators in chronic pain patients a prospective cohort study