Systematically Testing the Evidence on Marijuana

The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.

First Posted: September 20, 2021

Condition(s): Cannabis

Intervention(s): CBD 1mg/Kg, CBD 2mg/Kg, CBD 4mg/Kg, Placebo CBD

Status: Completed

Enrollment (expected or actual): 21

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): June 1, 2023

CT.gov Identifier: NCT05049733

Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreationally, may indicate disease severity, impart therapeutic benefits, or adverse consequences. In fact, cannabis is recommended to those with HIV to alleviate nausea, improve appetite, relieve pain, and lift mood. To-date, the consequences of cannabis use in PWH remain unclear as do potential interactions with HIV treatments. In healthy participants, heavy cannabis use is associated with cognitive deficits e.g., risky decision-making, response disinhibition and inattention, but pro-cognitive effects in PWH may exist at mild use levels due to its anti-inflammatory and anti-excitotoxic properties. Furthermore, little has been done to determine the effects of cannabis use on the endocannabinoid (EC) system in general or in PWH. This study will determine the effects of the two primary cannabis constituents (Δ9-tetrahydrocannabinol [THC], cannabidiol [CBD]) vs. placebo on risky decision-making, response inhibition, reward learning, temporal perception, and motivation, plus EC and homovanillic acid (HVA; a surrogate for dopamine activity) levels in HIV+ and HIV- subjects. Participants with infrequent cannabis use will undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified. They will be randomized to a 5-day course of either THC, CBD, or placebo and return for follow-up testing and re-assaying of ECs and HVA levels.

First Posted: May 12, 2021

Condition(s): HIV-1-infection

Intervention(s): 10 mg Δ9-tetrahydrocannabinol (THC), 600 mg cannabidiol (CBD), Placebo

Status: Recruiting

Enrollment (expected or actual): 138

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Arpi Minassian, Clinical Professor of Psychiatry

Completion Date (primary or actual): January 31, 2026

CT.gov Identifier: NCT04883255

Chronic inflammation, which is defined as a persistent, low-grade inflammatory response within the body, is associated with many of the negative health conditions which are prevalent in our society today. It is most well-known for its role in the progression of diseases including obesity, metabolic syndrome, cancer, cardiovascular disease, and diabetes. Chronic inflammation is also linked to many of the underlying factors associated with disease development including perturbations in sleep, and mental health status such as depression, anxiety, fatigue, and quality of life. Natural killer cells, commonly referred to as NK cells, are a subset of white blood cells that play an important role in the coordination of inflammation in the body. Although many interventions aimed at controlling chronic inflammation and enhancing NK cell number and activity have been explored, relatively few have been administered without significant barriers. Cannabidiol (CBD), a non-psychoactive hemp derivative, is a potential, attractive therapeutic target. However, there is very little information in humans that addresses the potential of CBD to improve your health and immune function. The overall goal of this study is to explore the effects of 8-weeks of CBD supplementation on mental and physical health, sleep measures, and NK cell number and cytotoxic function. Specific Aim 1. Explore the effect of 8-weeks of CBD administration on sleep measures as well as measures of mental and physical health in conjunction with measurements of NK cell number and function.

First Posted: May 11, 2021

Condition(s): Healthy

Intervention(s): Cannabidiol (CBD)

Status: Completed

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: University of Northern Colorado

Principal Investigator: Laura Stewart, Professor

Completion Date (primary or actual): March 18, 2022

CT.gov Identifier: NCT04881539

The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma. A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls. This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.

First Posted: May 4, 2021

Condition(s): Intrusive Memories

Intervention(s): Dronabinol, Placebo

Status: Recruiting

Enrollment (expected or actual): 291

Allocation: Randomized

Sponsor: Charite University, Berlin, Germany

Principal Investigator: Stefan Roepke, Prof. Dr.

Completion Date (primary or actual): October 31, 2023

CT.gov Identifier: NCT04871269

No studies of cannabidiol (CBD) have focused on Anorexia Nervosa (AN). Dose, side effects, tolerability, acceptability of pure CBD in AN must be established. The current study is an important first step in the investigation of CBD for AN. Cannabis products have been recently legalized in many states, and CBD in particular has been shown to reduce anxiety. Therefore, CBD may represent a promising new treatment for AN. The endocannabinoid system is involved in the regulation of functions relevant to eating disorders. Furthermore, data suggest that eating disorders are associated with alterations of the endocannabinoid system. Prior attempts to target the endocannabinoid system in AN have focused on CB1 receptor agonists that can increase anxiety. Moreover, CBD may be particularly beneficial in decreasing anxiety in AN via its action at serotonin receptors. Lastly, the impact of CBD on eating behavior and weight in AN must be determined. The current study seeks to explore these hypotheses using the aims in the following section.

First Posted: May 7, 2021

Condition(s): Anorexia Nervosa

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Guido Frank, Professor

Completion Date (primary or actual): May 2024

CT.gov Identifier: NCT04878627

Cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. Validated care has limited effectiveness in this population and development of new management strategies seems necessary. Transcranial direct current stimulation (tDCS) has shown beneficial effects in both schizophrenia, substance use disorder and, in a less extent, in nicotine addiction in schizophrenic subjects. It is interesting to test if that 10 sessions of anodal stimulation of the right dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation of the medial prefrontal cortex (MPFC) (by increasing control and modulating reward system), will reduce, in 110 schizophrenic subjects, cannabis consumption, and secondly craving, addiction severity, schizophrenic symptoms and improve global functioning. It is possible that these clinical effects will be associated with changes in certain cognitive functions and cerebral connectivity.

First Posted: May 4, 2021

Condition(s): Schizophrenia, Cannabis-Induced Disorder

Intervention(s): Transcranial direct current stimulation (tDCS) active, Transcranial direct current stimulation (tDCS) non active

Status: Recruiting

Enrollment (expected or actual): 110

Allocation: Randomized

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Principal Investigator:

Completion Date (primary or actual): September 1, 2025

CT.gov Identifier: NCT04871048

The purpose of this study is to determine the feasibility and impact of 28-days of monitored abstinence from cannabis use on symptoms of depression and anxiety, pain, sleep, cannabis use withdrawal, HIV viral load and biomarkers of systemic inflammation among PLWH and who use cannabis regularly (weekly or more often). This will be a single arm pilot feasibility trial involving a contingency management program to induce cannabis abstinence. Specifically, the contingency management program will provide motivational (monetary) incentives to participants who achieve biochemically verified cannabis abstinence. Over the 28-days of this pilot feasibility trial, participants will attend seven study visits. During these visits, participants will complete survey questionnaires to assess sociodemographic, psychosocial, and behavioral factors. In addition, participants will provide blood and urine specimens for testing and quantitation of HIV viral load, biomarkers of systemic inflammation and for the detection of cannabis and other drugs of abuse.

First Posted: April 29, 2021

Condition(s): Marijuana, HIV Infections

Intervention(s): Contingency Management - Cannabis

Status: Recruiting

Enrollment (expected or actual): 45

Allocation: N/A

Sponsor: The University of Texas Health Science Center at San Antonio

Principal Investigator: Chukwuemeka Okafor, Assistant Professor

Completion Date (primary or actual): February 1, 2024

CT.gov Identifier: NCT04866004

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.

First Posted: May 5, 2021

Condition(s): Alcohol Use Disorder

Intervention(s): Cannabidiol, Placebo

Status: Completed

Enrollment (expected or actual): 45

Allocation: Randomized

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): May 31, 2023

CT.gov Identifier: NCT04873453

Alcohol and Cannabis (CNB) are two of the most widely used intoxicants. The effects of driving while intoxicated on alcohol are well documented, resulting in numerous drunken driving laws and regulations. As CNB begins to be decriminalized, medical CNB use allowed in multiple U.S. states, and perception of harmfulness falls, CNB use is predicted to rise and it will become increasingly common to publicly encounter persons who recently used the drug. An area of potentially high concern is if ever-greater numbers of CNB users and its legalization will increase the risk of driving while intoxicated from recent CNB use, thereby increasing the risks to public safety. This study aims to examine the combined effects of smoking marijuana and drinking alcohol on simulated driving.

First Posted: April 23, 2021

Condition(s): Marijuana Impairment, Alcohol Impairment

Intervention(s): Low Marijuana, Hash, THC, or Grass, High Marijuana, Hash, THC, or Grass, Placebo, 0.05 BAC Alcohol, 0.08 BAC Alcohol

Status: Active, not recruiting

Enrollment (expected or actual): 12

Allocation: Randomized

Sponsor: Yale University

Principal Investigator: Godfrey Pearlson, Principal Investigator

Completion Date (primary or actual): April 2024

CT.gov Identifier: NCT04856566

Memory deficits are one of the most consistently observed cognitive effects of marijuana use. There is evidence that some decrements attributable to the primary psychoactive ingredient, delta-9-tetrahydrocannabinol (THC), may be attenuated by cannabidiol (CBD). This study will help us learn more about the relationship between THC and CBD consumption with memory processes. A combination of MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure the neurocognitive and behavioral impacts of THC and CBD use.

First Posted: April 22, 2021

Condition(s): Marijuana Use, Cannabis Use, Cannabis Intoxication

Intervention(s): High THC/No CBD Marihuana, High THC/High CBD Marihuana, No THC/No CBD Marihuana

Status: Not yet recruiting

Enrollment (expected or actual): 9

Allocation: Randomized

Sponsor: Hartford Hospital

Principal Investigator: Godfrey Pearlson, Founding Director Olin Neuropsychiatry Research Center; Professor Yale University

Completion Date (primary or actual): June 30, 2022

CT.gov Identifier: NCT04855526

This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.

First Posted: April 26, 2021

Condition(s): Pain, Appetite Loss, Abuse, Drug

Intervention(s): Placebo, Low CBG, High CBG, Low THC, High THC

Status: Recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: University of California, Los Angeles

Principal Investigator: Ziva D. Cooper, PhD, Associate Professor

Completion Date (primary or actual): December 22, 2024

CT.gov Identifier: NCT04859296

This was a study investigating RAD011 in participants diagnosed with Prader-Willi Syndrome (PWS). The primary objective of the Phase 2 part of this study was to assess the safety and tolerability of multiple dose levels of RAD011 in order to select 1 or 2 dose level(s) for further evaluation in the Phase 3 part of the study. In Phase 3, the primary objective was to assess the effect of RAD011 on hyperphagia-related behavior in participants with PWS.

First Posted: October 28, 2021

Condition(s): Prader-Willi Syndrome

Intervention(s): RAD011, Placebo

Status: Terminated

Enrollment (expected or actual): 4

Allocation: Randomized

Sponsor: Radius Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): October 6, 2022

CT.gov Identifier: NCT05098509

The acute effects of cannabis may differ between adolescents and adults. Furthermore, these effects may be tempered by the presence of cannabidiol. This double-blind, placebo-controlled, crossover experiment investigates the acute effects of cannabis (with and without cannabidiol) on subjective effects, behavioural responses and neural functioning in 16-17 year-olds and 26-29 year-olds who regularly use cannabis (0.5-3 days per week).

First Posted: April 20, 2021

Condition(s): Cannabis, Cannabis Intoxication, Cannabis Use, Cannabis Dependence, Marijuana, THC, CBD, Adolescent Development

Intervention(s): Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), Cannabis with THC without CBD, Placebo cannabis

Status: Completed

Enrollment (expected or actual): 48

Allocation: Randomized

Sponsor: University College, London

Principal Investigator:

Completion Date (primary or actual): June 16, 2021

CT.gov Identifier: NCT04851392

This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. We will study how varying ratios of THC and CBD in medical cannabis impact neuropathic pain, inflammation and adverse events.

First Posted: April 26, 2021

Condition(s): HIV Infections, Neuropathic Pain, Cannabis

Intervention(s):

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation:

Sponsor: Montefiore Medical Center

Principal Investigator: Deepika Slawek, Assistant Professor of Medicine

Completion Date (primary or actual): December 12, 2023

CT.gov Identifier: NCT04860089

The purposes of the study are 1) to know the concentrations of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) and other cannabinoids in blood, urine, oral fluid and sweat after the experimental administration of a standardized cannabis preparation orally (decoction and oil) and vaporized 2) to evaluate the pharmacological acute effects and tolerability

First Posted: April 12, 2021

Condition(s): Cannabis Use, Healthy Subjects

Intervention(s): Cannabis decoction, Cannabis oil, Vaporized cannabis

Status: Completed

Enrollment (expected or actual): 43

Allocation: Non-Randomized

Sponsor: Germans Trias i Pujol Hospital

Principal Investigator:

Completion Date (primary or actual): December 18, 2019

CT.gov Identifier: NCT04841993

The Cannabinoide Hyperemesis Syndrom (CHS) is defined as a recurrent syndrome of intractable vomiting that occurs in chronic cannabis consumers. The diagnosis is linked to clinical criteria only. The physiopathology of CHS is unknown and we observe an increase of cases with this syndrom since 2016 (Schreck et al., 2018). The aim of this study is to investigate the involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS.

First Posted: April 8, 2021

Condition(s): Chronic Consumption of Cannabis

Intervention(s): 1 blood sample

Status: Recruiting

Enrollment (expected or actual): 200

Allocation: N/A

Sponsor: Poitiers University Hospital

Principal Investigator:

Completion Date (primary or actual): June 30, 2023

CT.gov Identifier: NCT04836611

Adults (ages 18+) who would like to reduce their cannabis use (N=224) will be enrolled in an 8-week treatment program. All participants will receive counseling (1 goals session with a therapist followed by 7 weekly computerized cognitive-behavioral therapy sessions). Detailed cannabis assessments (biological and self-report) will be conducted throughout treatment and at 1-, 2-, and 3-months post-treatment completion. Daily electronic diaries will be administered via text message to record detailed logs of cannabis use quantity and frequency. Salivary samples will be collected (and video observed) daily throughout treatment to analyze for progesterone.

First Posted: July 16, 2021

Condition(s): Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Intervention(s): Cognitive Behavioral Therapy (CBT4CBT)

Status: Recruiting

Enrollment (expected or actual): 224

Allocation: Non-Randomized

Sponsor: Medical University of South Carolina

Principal Investigator: Rachel Tomko, Research Assistant Professor

Completion Date (primary or actual): March 31, 2025

CT.gov Identifier: NCT04964739

Cannabidiol (CBD) is a phytocannabinoid that is one of 113 identified cannabinoids in the cannabis plant. It is derived from the hemp plant, and may treat conditions like pain, insomnia, and anxiety. CBD is a critical component of medical marijuana and does not cause the "high" typically associated with cannabis. According to the World Health Organization, CBD has shown no evidence of abuse or dependence potential. However, to the investigator's knowledge, there have not been many acute clinical studies to characterize the effects of CBD in the brain. Despite the rapid influx in CBD readily available to the public, very little is known about such effects. Some studies have shown alterations in resting state connectivity, while others have described changes in specific regions of the brain, or in networks associated with various cognitive functions. For example, CBD has been shown to increase fronto-striatal connectivity and reduce mediotemporal-prefrontal connectivity, suggesting that CBD may affect brain regions involved in salience processing. Unfortunately, few studies have examined CBD in isolation. Additionally, several studies have suggested that CBD may have a neuroprotective effect when it comes to individuals at high risk for psychiatric conditions. In this study, the investigators propose an acute administration, double-blind, placebo-controlled study in which 100% THC-free CBD will be compared to placebo (https://foliumbiosciences.com/). To the investigator's knowledge, the acute effects of this specific product have not been tested. Specifically, the investigators will examine: 1) the neurometabolic and neurophysiological effects of CBD compared to placebo and 2) the behavioral effects of CBD on measures of working memory and response inhibition. Participants will be recruited to take encapsulated, THC-free CBD provided by Folium Biosciences, in which they will have a pre- and post-ingestion scan. Each participant will have a 72-hour washout period after which they will be asked to come back for a placebo scan (however, the order will be counterbalanced so that equal numbers of participants will receive placebo/supplement and supplement/placebo). Individuals will be randomized into the supplementation group, as well as the order.

First Posted: April 5, 2021

Condition(s): CBD, Fear, Inhibition

Intervention(s): Cannabidiol, Placebo

Status: Active, not recruiting

Enrollment (expected or actual): 15

Allocation: Randomized

Sponsor: Auburn University

Principal Investigator: Jennifer L. Robinson, Ph.D., Professor

Completion Date (primary or actual): May 15, 2022

CT.gov Identifier: NCT04831294

This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS).

First Posted: April 1, 2021

Condition(s): Opioid Use, Pain, Marijuana Use

Intervention(s): Medical Marijuana, Prescription Opioid Taper Support (POTS)

Status: Recruiting

Enrollment (expected or actual): 250

Allocation: Randomized

Sponsor: Massachusetts General Hospital

Principal Investigator: Jodi Gilman, Associate Professor

Completion Date (primary or actual): June 30, 2025

CT.gov Identifier: NCT04827992

This is a multi-site, double-blind, parallel group, randomized, placebo-controlled study of 140 participants comparing oral purified cannabidiol isolate (CBD) with placebo in reducing Severe Behavioral Problems (SBP) at 8 weeks in children aged 6 - 18 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo.

First Posted: March 30, 2021

Condition(s): Intellectual Disability, Child Behavior Problem

Intervention(s): Cannabidiol Oil, Placebo

Status: Recruiting

Enrollment (expected or actual): 140

Allocation: Randomized

Sponsor: Murdoch Childrens Research Institute

Principal Investigator:

Completion Date (primary or actual): June 2024

CT.gov Identifier: NCT04821856

Clinical evidence about the effects of cannabis in the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute pain, at least for a selected group of patients and through an appropriate therapeutic intervention. Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. And will help treat acute radicular back pain

First Posted: March 25, 2021

Condition(s): Acute Radicular Back Pain, Cannabis

Intervention(s): Single-dose of cannabis oil, Control

Status: Recruiting

Enrollment (expected or actual): 200

Allocation: Randomized

Sponsor: Hadassah Medical Organization

Principal Investigator: Elyad Davidson, Director Pain Relief Unit

Completion Date (primary or actual): December 31, 2022

CT.gov Identifier: NCT04816994

This is a multi-centre, long term, double blind, clinical protocol for NanaBis™ as a monotherapy treatment in participants 18-75 years of age with cancer related pain.

First Posted: March 22, 2021

Condition(s): Cancer Related Pain

Intervention(s): NanaBis™, Oxycodone CR, Placebo Spray, Placebo Tablet, Oxycodone IR

Status: Not yet recruiting

Enrollment (expected or actual): 360

Allocation: Randomized

Sponsor: Medlab Clinical

Principal Investigator:

Completion Date (primary or actual): February 2024

CT.gov Identifier: NCT04808531

This study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on HIV-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with HIV.

First Posted: March 23, 2021

Condition(s): Cannabis, HIV, Inflammation, Cognition, Neuroimaging

Intervention(s): Multimodal, multi-parametric MRI, Immune and cytokine profiling, Neuropsychological testing

Status: Recruiting

Enrollment (expected or actual): 220

Allocation: Non-Randomized

Sponsor: Wake Forest University Health Sciences

Principal Investigator:

Completion Date (primary or actual): May 31, 2025

CT.gov Identifier: NCT04810858

Aims: To identify the predictors associated with smoking cessation in smokers under treatment for alcohol and/or cannabis treated in drug treatment centers (DTC). Methodology: Mixed methods project with qualitative and quantitative designs (three studies). Study I discussion groups: of clinical professionals of DTC to explore the barriers/facilitators of these smokers in quitting and the interventions carried out. Study II Prospective cohort of smokers in alcohol and/or cannabis treatment that will be followed-up for 12 months. Sample size: difference in incidence (exposed to cessation interventions versus non-exposed = 12 per 100 years), α = 0.05, β = 0.10, losses = 20% (n = 726). Dependent variables: self-reported and verified tobacco consumption abstinence, quit attempts, motivation, and self-efficacy. Independent variables: age, sex, the substance under treatment. Analysis: incidence, relative risk and simple and multiple logistic regression models (odds ratio and confidence interval, CI, 95%) of quitting. Study III discussion groups: with smokers under alcohol and/or cannabis treatment selected according to their typology. Analysis: of thematic content and triangulation qualitative and quantitative results. Expected results: Characterization of variables that influence tobacco cessation, to improve the design of interventions.

First Posted: April 12, 2021

Condition(s): Mental Health Disorder, Substance Abuse Drug, Alcohol Abuse, Cannabis Use, Tobacco Use, Smoking Cessation

Intervention(s):

Status: Recruiting

Enrollment (expected or actual): 1625

Allocation:

Sponsor: Institut Català d'Oncologia

Principal Investigator:

Completion Date (primary or actual): October 2021

CT.gov Identifier: NCT04841655

This study will address whether cannabis affects antiretroviral therapy (ART) drug concentrations, mood, and thinking. The project will have two phases. Phase 1 is an observational study, in which 120 people will be assessed to evaluate the effects of chronic cannabis use on ART drug concentrations, mood, and thinking. In Phase 2, the study will administer cannabis (or placebo) to 40 people to examine its acute effects on ART drug concentrations.

First Posted: March 16, 2021

Condition(s): HIV, Cannabis Use

Intervention(s): THC Cannabis, CBD Cannabis, Placebo

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Scott Letendre, Professor

Completion Date (primary or actual): January 30, 2025

CT.gov Identifier: NCT04800159