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Cannabis clinical trials

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NCT ID: NCT04576507 Suspended - Pain Clinical Trials

Repeated Cannabis Administration on Experimental Pain and Abuse Liability

Start date: June 1, 2021
Phase: Phase 1
Study type: Interventional

Chronic pain is a significant public health concern in the U.S., for which prescription opioids have historically been the standard treatment. This has resulted in striking rates of opioid use disorders and fatal overdoses. Identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. More than 80% of medicinal cannabis users report pain as their primary medical indication. These patients tend to seek products that are low in delta-9-tetrahydrocannabinol (THC; the primary psychoactive, and thus intoxicating, component of cannabis), and high in cannabidiol (CBD), a cannabinoid that purportedly has therapeutic benefit for pain but does not produce intoxicating effects [1]. However, there are few well-controlled human laboratory studies assessing the efficacy of high-CBD cannabis for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability. The proposed randomized, within-subjects, placebo-controlled 16-day crossover inpatient human laboratory pilot study (N = 16 healthy cannabis users; 8 men, 8 women) will address important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) If repeated cannabis use can result in hyperalgesia; 2) If tolerance to the analgesic and abuse-related effects of cannabis develops and is reversible. Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS), and participants will smoke cannabis 3x/day. Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.

NCT ID: NCT04567238 Completed - Cannabis Use Clinical Trials

Impact of Reduced Cannabis Use on Functional Outcomes (R33 Phase)

FOCUS
Start date: March 19, 2021
Phase: N/A
Study type: Interventional

Nearly 20 million Americans report use of cannabis in the past month, and heavy cannabis use has increased by nearly 60% in the U.S. since 2007. Heavy cannabis use is associated with lower educational attainment, reduced physical activity, increased rates of addiction and unemployment, and neuropsychological deficits. Studies suggest that cannabis use is also associated with increased mental health symptoms, drugged driving, and traffic accidents. While there is evidence that sustained abstinence can lead to improvements in the functional outcomes of former users, the degree to which reductions alone (i.e., not sustained abstinence) in cannabis use might be associated with positive changes in functional outcomes is unknown. This is a critical gap in the literature, as many interventions for cannabis and other drugs are associated with decreases in frequency and quantity of use, but fail to achieve an effect on overall abstinence rates. The objective of the present research is to use ecological momentary assessment (EMA), a real-time, naturalistic data collection method, to prospectively study the impact of reduced cannabis use on functional outcomes in heavy cannabis users. Contingency management (CM) will be used to promote reductions in frequency and quantity of cannabis use. CM is an intensive behavioral therapy that is highly effective at producing short-term reductions in illicit drug use. We have recently developed a novel approach that leverages mobile technology and recent developments in cannabis testing. We have pilot-tested this approach with heavy cannabis users and found that it is an acceptable and feasible method. The present research will use this technology in conjunction with EMA methods to study the impact of reduced cannabis use on key functional outcomes. Our central hypothesis is that reductions in frequency and quantity of cannabis use will lead to positive changes in cannabis users' mental health, self-efficacy, physical activity, working memory, health-related quality of life, and driving behavior. The rationale for this research is that it will provide the first and only real-time data concerning the potential impact of reductions in cannabis use on functional outcomes. As such, the findings from the present research will directly inform ongoing efforts to include reductions in illicit drug use as a valid, clinically-meaningful outcome measure in clinical trials of pharmacotherapies for the treatment of substance use disorders.

NCT ID: NCT04429568 Recruiting - Nicotine Dependence Clinical Trials

THC Crossover Study

TRDRP
Start date: October 30, 2020
Phase: N/A
Study type: Interventional

This is a randomized, crossover study enrolling experienced dual cannabis-tobacco smokers (N=18) to describe the differences in THC and toxicant exposure, examining pharmacokinetic, subjective, and cardiovascular effects from smoking and vaping dry herb cannabis. This study will also examine the differences in toxicant exposure and cardiovascular disease risk between smoking cannabis and smoking tobacco cigarettes.

NCT ID: NCT04360044 Completed - Migraine Clinical Trials

Efficacy of Inhaled Cannabis for Acute Migraine Treatment

Start date: November 20, 2020
Phase: Phase 2
Study type: Interventional

This crossover study will evaluate 3 different treatments of vaporized cannabis (THC, THC/CBD mix, and CBD) and vaporized placebo cannabis for the acute treatment of migraine.

NCT ID: NCT04325958 Recruiting - Cannabis Clinical Trials

Age Differences in the Effects of Cannabis on Simulated Driving

ADCUF
Start date: March 27, 2024
Phase: N/A
Study type: Interventional

Epidemiological studies suggest that the use of cannabis is associated with an increase in the risk of motor vehicle collisions. It is also known that younger users may be at increased risk for motor vehicle collisions. Further, the frequency with which cannabis is used may be an important variable in determining the effects of cannabis on driving. The purpose of the present study will be to investigate the effects of cannabis on simulated driving in young as compared to middle-aged drivers. Half of the participants will be occasional users of cannabis and half will be frequent users of cannabis.

NCT ID: NCT04284813 Completed - Schizophrenia Clinical Trials

Families With Substance Use and Psychosis: A Pilot Study

Start date: September 24, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and evaluate an intervention that adapts Community Reinforcement and Family Training (CRAFT) for families experiencing first episode psychosis and substance use delivered via telemedicine (video conferencing). The intervention aims to improve treatment engagement and reduce distress, and it will be delivered via telemedicine (CRAFT-FT). To assess feasibility of the intervention, family members will complete the sessions and provide feedback to refine the treatment manual. Data on client relatives with psychosis will be collected for preliminary assessment purposes. Client relatives will not complete the research study intervention.

NCT ID: NCT04239469 Not yet recruiting - Fibromyalgia Clinical Trials

Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.

Start date: January 15, 2020
Phase: Phase 2
Study type: Interventional

A double blind randomized placebo controlled trial in 44 women with fibromyalgia and persistent symptoms in spite of use of conventional pharmacotherapy, will be performed in the city of Valparaiso. Patients will be randomized to either placebo or active principle and be followed for 3 months. Assesment of efficacy and safety will be done by measurement of changes in their Fibromyalgia Impact Questionnaire (FIQ) score, Insomnia Severity Index (ISI) score, pain Visual Analogue Scale (VAS) score, plasma cytokine levels and detection of adverse effects. The active principle will be a standardized extract of cannabis sativa containing 1 milligram of tetrahydrocannabinol (THC) and 0.45 milligrams cannabidiol (CBD) per drop.

NCT ID: NCT04199468 Completed - Cannabis Clinical Trials

THC and Ketamine Effects in Humans: Relation to Neural Oscillations and Psychosis

Start date: September 24, 2019
Phase: Phase 1
Study type: Interventional

The aim of the research protocol is to evaluate cannabinoid-glutamate interactions in humans. As part of this aim the investigators will assess the safety and tolerability of the combination of NMDA antagonist, ketamine, and the cannabinoid, delta-9-tetrahydrocannabinol (THC), in healthy adult subjects, and characterize the interactive effects of ketamine and THC on various electrophysiological (EEG), cognitive, and behavioral outcomes.

NCT ID: NCT04124432 Completed - Cannabis Clinical Trials

Behavioral Pharmacology of Cannabis and Nicotine

Start date: September 15, 2020
Phase: Phase 1
Study type: Interventional

This study will evaluate the individual and interactive pharmacokinetic and pharmacodynamic effects of smoked cannabis and nicotine.

NCT ID: NCT04036968 Completed - Pain Clinical Trials

Enhancing Medication-based Analgesia in Humans- STUDY 2

Start date: February 1, 2020
Phase: Phase 2
Study type: Interventional

This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of studies.