Terpenes + THC for Pain
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of California, Los Angeles
Must not be taking: Prescription analgesics
Disqualifiers: Substance use disorder, Hypertension, Pregnancy, others
Trial Summary
What is the purpose of this trial?The purpose of this research is to assess the analgesic and subjective effects of terpenes administered alone and in combination of THC.
Will I have to stop taking my current medications?
Yes, if you are currently using prescription pain medications or any medications that might affect the study outcomes, you will need to stop taking them to participate in this trial.
What data supports the effectiveness of this drug for pain relief?
Research shows that β-caryophyllene (BCP), a component of the treatment, can reduce pain by interacting with cannabinoid and opioid systems in the body. This suggests that BCP might help in pain relief, which could support the effectiveness of the treatment for pain.
12345Is the combination of terpenes and THC safe for human use?
β-Caryophyllene (BCP), a terpene found in cannabis, is considered safe as it is approved by the FDA and European agencies as a food additive. It has been used for many years without significant safety concerns.
13456What makes the drug Terpenes + THC for Pain unique compared to other pain treatments?
This drug is unique because it combines terpenes like β-caryophyllene (BCP) and myrcene with THC, which may offer pain relief through a novel mechanism involving the activation of the CB2 receptor, potentially reducing inflammation without the psychoactive effects associated with CB1 receptor activation. BCP also has potential anticancer properties, making it particularly valuable for patients experiencing chronic pain related to cancer.
13457Eligibility Criteria
This trial is for adults aged 21-55 who use cannabis recreationally 1-7 times a week and are not seeking treatment for cannabis use. They must have a BMI of 18.5 - 34kg/m2, be able to do all study tasks, and use contraception. People with significant illnesses, pregnant women, those allergic to cannabis or on certain medications can't join.Inclusion Criteria
You are not currently using marijuana as part of your treatment plan.
I am between 21 and 55 years old and not pregnant.
Urine test positive for recent cannabis use
+4 more
Exclusion Criteria
You have a substance addiction, except for nicotine or caffeine.
I am experiencing pain.
Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive various combinations of terpenes and THC to assess analgesic and subjective effects
7 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1-2 weeks
Participant Groups
The study aims to evaluate the pain-relief and subjective effects of terpenes both alone and when combined with THC. Participants will receive varying levels of Beta-Caryophyllene (high/low), Myrcene (high/low), THC (high/low), or placebo in different sessions.
15Treatment groups
Active Control
Placebo Group
Group I: Low strength BCPActive Control1 Intervention
0 mg THC, 0 mg myrcene, 0.5 mg BCP
Group II: High strength myrceneActive Control1 Intervention
0 mg THC, 12.0 mg myrcene, 0 mg BCP
Group III: High THC + Low myrcerneActive Control2 Interventions
15 mg THC, 0.5 mg myrcene, 0 mg BCP
Group IV: High strength BCPActive Control2 Interventions
15 mg THC, 0 mg myrcene, 7.5 mg BCP
Group V: Low strength myrceneActive Control1 Intervention
0 mg THC, 0.5 mg myrcene, 0 mg BCP
Group VI: Higher strength THCActive Control1 Intervention
15 mg THC, 0 mg myrcene, 0 mg BCP
Group VII: High THC + High BCPActive Control2 Interventions
15 mg THC, 0 mg myrcene, 7.5 mg BCP
Group VIII: Low THC + Low myrceneActive Control2 Interventions
5 mg THC, 0.5 mg myrcene, 0 mg BCP
Group IX: Low THC + High myrceneActive Control2 Interventions
5 mg THC, 12.0 mg myrcene, 0 mg BCP
Group X: High THC + High myrceneActive Control2 Interventions
15 mg THC, 12.0 mg myrcene, 0 mg BCP
Group XI: Low THC + Low BCPActive Control2 Interventions
5 mg THC, 0 mg myrcene, 0.5 mg BCP
Group XII: Low THC + High BCPActive Control2 Interventions
5 mg THC, 0 mg myrcene, 7.5 mg BCP
Group XIII: High THC + Low BCPActive Control2 Interventions
15 mg THC, 0 mg myrcene, 0.5 mg BCP
Group XIV: Low strength THCActive Control1 Intervention
5 mg THC, 0 mg myrcene, 0 mg BCP
Group XV: PlaceboPlacebo Group1 Intervention
0 mg THC, 0 mg myrcene, 0 mg BCP
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, Los AngelesLos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)Collaborator
References
Polypharmacological Properties and Therapeutic Potential of β-Caryophyllene: A Dietary Phytocannabinoid of Pharmaceutical Promise. [2019]β-Caryophyllene (BCP) is a natural bicyclic sesquiterpene abundantly found in essential oils from various spices, fruits and medicinal as well as ornamental plants. It is approved by United States Food and Drug Administration and European agencies as food additive, taste enhancer and flavoring agent and termed as a phytocannabinoid.
β-Caryophyllene inhibits dextran sulfate sodium-induced colitis in mice through CB2 receptor activation and PPARγ pathway. [2021]Cannabinoid receptor 2 (CB2) activation is suggested to trigger the peroxisome proliferator-activated receptor-γ (PPARγ) pathway, and agonists of both receptors improve colitis. Recently, the plant metabolite (E)-β-caryophyllene (BCP) was shown to bind to and activate CB2. In this study, we examined the anti-inflammatory effect of BCP in dextran sulfate sodium (DSS)-induced colitis and analyzed whether this effect was mediated by CB2 and PPARγ. Oral treatment with BCP reduced disease activity, colonic macro- and microscopic damage, myeloperoxidase and N-acetylglucosaminidase activities, and levels and mRNA expression of colonic tumor necrosis factor-α, IL-1β, interferon-γ, and keratinocyte-derived chemokine. BCP treatment also inhibited the activation of extracellular signal-regulated kinase 1/2, nuclear factor κB, IκB-kinase α/β, cAMP response element binding and the expression of caspase-3 and Ki-67. Moreover, BCP enhanced IL-4 levels and forkhead box P3 mRNA expression in the mouse colon and reduced cytokine levels (tumor necrosis factor-α, keratinocyte-derived chemokine, and macrophage-inflammatory protein-2) in a culture of macrophages stimulated with lipopolysaccharide. The use of the CB2 antagonist AM630 or the PPARγ antagonist GW9662 significantly reversed the protective effect of BCP. Confirming our results, AM630 reversed the beneficial effect of BCP on pro-inflammatory cytokine expression in IEC-6 cells. These results demonstrate that the anti-inflammatory effect of BCP involves CB2 and the PPARγ pathway and suggest BCP as a possible therapy for the treatment of inflammatory bowel disease.
Effects of β -caryophyllene, A Dietary Cannabinoid, in Animal Models of Drug Addiction. [2023]β-caryophyllene (BCP) is a natural bicyclic sesquiterpene found in Cannabis and other plants. BCP is currently used as a food additive, although pharmacological studies suggest its potential therapeutic application for the treatment of certain brain disorders. The mechanisms of action of BCP remain uncertain, possibly including full agonism at the cannabinoid CB2 receptor (CB2R).
Involvement of peripheral cannabinoid and opioid receptors in β-caryophyllene-induced antinociception. [2019]β-caryophyllene (BCP) is a common constitute of the essential oils of numerous spice, food plants and major component in Cannabis. The present study investigated the contribution of peripheral cannabinoid (CB) and opioid systems in the antinociception produced by intraplantar (i.pl.) injection of BCP. The interaction between peripheral BCP and morphine was also examined.
β-Caryophyllene Mitigates Collagen Antibody Induced Arthritis (CAIA) in Mice Through a Cross-Talk between CB2 and PPAR-γ Receptors. [2020]β-caryophyllene (BCP) is a cannabinoid receptor 2 (CB2) agonist that tempers inflammation. An interaction between the CB2 receptor and peroxisome proliferator-activated receptor gamma (PPAR-γ) has been suggested and PPAR-γ activation exerts anti-arthritic effects. The aim of this study was to characterize the therapeutic activity of BCP and to investigate PPAR-γ involvement in a collagen antibody induced arthritis (CAIA) experimental model. CAIA was induced through intraperitoneal injection of a monoclonal antibody cocktail and lipopolysaccharide (LPS; 50 μg/100 μL/ip). CAIA animals were then randomized to orally receive either BCP (10 mg/kg/100 μL) or its vehicle (100 μL of corn oil). BCP significantly hampered the severity of the disease, reduced relevant pro-inflammatory cytokines, and increased the anti-inflammatory cytokine IL-13. BCP also decreased joint expression of matrix metalloproteinases 3 and 9. Arthritic joints showed increased COX2 and NF-ĸB mRNA expression and reduced expression of the PPARγ coactivator-1 alpha, PGC-1α, and PPAR-γ. These conditions were reverted following BCP treatment. Finally, BCP reduced NF-ĸB activation and increased PGC-1α and PPAR-γ expression in human articular chondrocytes stimulated with LPS. These effects were reverted by AM630, a CB2 receptor antagonist. These results suggest that BCP ameliorates arthritis through a cross-talk between CB2 and PPAR-γ.
β-Caryophyllene, a dietary terpenoid, inhibits nicotine taking and nicotine seeking in rodents. [2022]Label="BACKGROUND AND PURPOSE">β-Caryophyllene (BCP) is a plant-derived terpenoid used as a food additive for many decades. Recent studies indicate that BCP is a cannabinoid CB2 receptor agonist with medical benefits for a number of human diseases. However, little is known about its therapeutic potential for drug abuse and addiction.
β-caryophyllene and β-caryophyllene oxide-natural compounds of anticancer and analgesic properties. [2022]Natural bicyclic sesquiterpenes, β-caryophyllene (BCP) and β-caryophyllene oxide (BCPO), are present in a large number of plants worldwide. Both BCP and BCPO (BCP(O)) possess significant anticancer activities, affecting growth and proliferation of numerous cancer cells. Nevertheless, their antineoplastic effects have hardly been investigated in vivo. In addition, both compounds potentiate the classical drug efficacy by augmenting their concentrations inside the cells. The mechanisms underlying the anticancer activities of these sesquiterpenes are poorly described. BCP is a phytocannabinoid with strong affinity to cannabinoid receptor type 2 (CB2 ), but not cannabinoid receptor type 1 (CB1 ). In opposite, BCP oxidation derivative, BCPO, does not exhibit CB1/2 binding, thus the mechanism of its action is not related to endocannabinoid system (ECS) machinery. It is known that BCPO alters several key pathways for cancer development, such as mitogen-activated protein kinase (MAPK), PI3K/AKT/mTOR/S6K1 and STAT3 pathways. In addition, treatment with this compound reduces the expression of procancer genes/proteins, while increases the levels of those with proapoptotic properties. The selective activation of CB2 may be considered a novel strategy in pain treatment, devoid of psychoactive side effects associated with CB1 stimulation. Thus, BCP as selective CB2 activator may be taken into account as potential natural analgesic drug. Moreover, due to the fact that chronic pain is often an element of cancer disease, the double activity of BCP, anticancer and analgesic, as well as its beneficial influence on the efficacy of classical chemotherapeutics, is particularly valuable in oncology. This review is focused on anticancer and analgesic activities of BCP and BCPO, the mechanisms of their actions, and potential therapeutic utility.