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Marijuana Abuse clinical trials

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NCT ID: NCT03729869 Completed - Cannabis Use Clinical Trials

Impact of Progesterone on Stress Reactivity and Cannabis Use

Start date: January 18, 2019
Phase: Phase 2
Study type: Interventional

This is a research study to find out if a hormone called progesterone affects marijuana users' stress response and marijuana use. Progesterone is a naturally occurring sex hormone involved in the menstrual cycle and reproduction, and has been shown to reduce withdrawal symptoms when people stop using substances like cocaine and nicotine. It is not FDA approved for treating cannabis users and is considered an investigational drug in this study.

NCT ID: NCT03727659 Completed - Depression Clinical Trials

CONNECT for Depressed Cannabis Users Trial

CONNECT
Start date: March 22, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to test the usefulness of a computer-assisted intervention for depressed cannabis users by combining peer and therapist social network support via Facebook that uses the techniques of cognitive behavioral therapy and motivational enhancement therapy (CBT/MET) to help with relapse prevention skills, reduce cannabis use and depressive symptoms, and improve treatment adherence. All participants will receive 10 weeks of the computer assisted intervention which includes weekly 60 minute (1 hour) sessions. All participants will also be part of a secret Facebook group (CONNECT). The goal of this secret Facebook group is to reinforce the knowledge and skills taught in the computer assisted intervention and to provide social support.

NCT ID: NCT03718520 Completed - Drug Use Clinical Trials

The Influence of in Utero Cannabis Exposure on Neonatal Brain Morphology and Structural Connectivity

Start date: November 7, 2018
Phase:
Study type: Observational

Cannabis is the most commonly used drug by women during pregnancy with an estimated prevalence of use in Colorado of 5.7%. THC and its metabolites freely cross the placenta and blood-brain barrier to bind with cannabinoid receptors, disrupting the endogenous cannabinoid signaling system during a critical period of development of cortical circuitry structure and function. The density of cannabinoid receptors in the developing brain is high, especially in the limbic areas and prefrontal lobes. Research in animal models suggests synaptic plasticity in the prefrontal lobes as well the amygdala and hippocampus are impacted by the prenatal cannabis exposure; regions associated with both cognitive and emotional control, thus influencing long-term deficiencies in attention and impulsivity. This pilot study will collect preliminary data on the structural impact of in utero cannabis exposure on region-specific morphology and structural connectivity of white matter tracts that connect to the prefrontal lobes and the limbic regions shortly after birth, before confounding by the postnatal environment becomes a major influence.

NCT ID: NCT03717272 Completed - Marijuana Abuse Clinical Trials

Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects

Start date: October 23, 2018
Phase: Phase 2
Study type: Interventional

Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority. The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects. This will be a single center study in healthy male and non-pregnant female, non-treatment seeking, cannabis smoking subjects with cannabis use disorder (CUD). The study design will be a randomized, double-blind, placebo-controlled, cross-over design, multiple dose escalation study with AEF0117. This study is designed to test the effects of two to four doses of AEF0117 compared to placebo on primarily peak subjective effects of cannabis as primary objectives. The secondary objectives are to test the effects of AEF0117 compared to placebo on cannabis self-administration, on cannabis-induced analgesia and on cognitive performance in cannabis smoking subjects. The study hypothesis is that AEF0117 will decrease ratings of cannabis' positive subject effects (e.g., 'good drug effect', high) and decrease cannabis self-administration compared to placebo and also decrease the other unconditioned effects of cannabis studied here. Each subject will have a screening visit, then be included for two 6-day inpatient periods separated by a minimum 14-day outpatient washout. Subjects will be advised that they will receive both active and placebo study medication but will remain blinded to whether they will receive AEF0117 or placebo on Period A and Period B. Each period is composed of 5 consecutive days of treatment (active or placebo), one administration per day. Research staff that interacts with study subjects will also remain blinded to whether subjects are receiving AEF0117 or placebo. The study duration for the first 3 doses of AEF0117 is estimated to be approximately up to 10 months from the start of subject recruitment to the last subject last visit.

NCT ID: NCT03705559 Completed - Opioid Use Clinical Trials

Opioid and Cannabinoid Interactions

Start date: June 21, 2019
Phase: Phase 1
Study type: Interventional

This study will examine the effects of doses of marijuana/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

NCT ID: NCT03699540 Completed - Alcohol Drinking Clinical Trials

Marijuana Effects on Simulated Driving Performance

Start date: July 1, 2019
Phase: Phase 1
Study type: Interventional

This study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.

NCT ID: NCT03699527 Completed - Autism Clinical Trials

Medical Cannabis Registry and Pharmacology

Med Can Autism
Start date: July 15, 2018
Phase:
Study type: Observational [Patient Registry]

The overall goals of this research is to describe the 1) natural history of current use and disposition of medical cannabis products including Cannabidiol (CBD) products, being administered to children as standard of care for the treatment of Autism Spectrum Disorder (ASD), 2) understand the pharmacokinetic and pharmacodynamics of medical cannabis products and 3) provide educational feedback on what is learned to families and care providers to provide evidenced based dosing guidance for these products to the pediatric community.

NCT ID: NCT03681353 Completed - Cannabis Use Clinical Trials

Impact of Reduced Cannabis Use on Functional Outcomes

Start date: April 4, 2019
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, and increased rates of addiction, unemployment, and neuropsychological deficits. Studies by the lab and others suggest that cannabis use is also associated with increased mental health symptoms and suicidal and nonsuicidal self-injury. In addition, cannabis is the illicit drug most strongly associated with drugged driving and traffic accidents, including fatal accidents. There is evidence that sustained abstinence from cannabis can lead to improvements in the functional outcomes of former users. However, he degree to which reductions in cannabis use might be associated with positive changes in functional outcomes is currently unknown. The overall objective of the present research is to use ecological momentary assessment (EMA), a real-time, naturalistic data collection method, to 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. The investigators novel approach includes mobile technology to make CM more portable and feasible. The present research will use this technology in conjunction with state-of-the-art EMA methods to study the impact of reduced cannabis use on key functional outcomes. The investigators central hypothesis is that reductions in frequency and quantity of cannabis use will lead to positive changes in cannabis users' mental health, physical activity, working memory, health-related quality of life, and driving behavior.

NCT ID: NCT03676166 Completed - Cannabis Clinical Trials

Pharmacokinetic and Pharmacodynamic Effects of Smoked and Vaporized Cannabis

Start date: June 16, 2016
Phase: Phase 1
Study type: Interventional

Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of smoked and vaporized cannabis. Careful analysis of different cannabis administration methods on these parameters is required to determine the level and duration of biological cannabinoid exposure and associated subjective, cardiovascular and cognitive effects. In the present study the investigators evaluated the detection of cannabinoids in whole blood, oral fluid, and urine, as well as the acute pharmacodynamics associated with smoked and vaporized cannabis among individuals who were not regular cannabis users. The outcomes of the study will extend scientific knowledge about the behavioral pharmacology and toxicology of smoked and vaporized cannabis administration and can inform policies regarding clinical, workplace and roadside drug testing programs.

NCT ID: NCT03664141 Withdrawn - Hemodialysis Clinical Trials

Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study)

ICON-HP
Start date: September 15, 2018
Phase: Phase 3
Study type: Interventional

The study will be performed in two parts: 1) The pharmacokinetic (PK) part and 2) The appetite and nutritional evaluation part. The PK part of study will be conducted in open label manner on 10 end stage kidney disease (ESKD) patients receiving maintenance hemodialysis (MHD) treatment. For the PK part, a starting dose of cannabis oil -1 drop of 3% cannabis oil once a day [each drop contain 1.2 mg CBD (cannabidiol) and 1.2 mg of ∆9-THC (∆9-tetrahydrocannabinol)], was judged to be safe for a first-in-MHD patient's administration. Escalation to the next higher dose and any dose adjustments of the next dose levels will be based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups. Once the first dosage proved to be safe, there will be a 2 fold increase from the first dose level (2 drops once a day) to the second dose level. The dose levels will be increased by 2-fold from the previous dose level, until basal hunger and prospective consumption ratings assessed by the visual analogue scale (VAS) will increase at least by 10 mm between screening and the study visits (change-from-baseline) . PK parameters will be evaluated after first dosage administration and after dosage increased. The appetite and nutritional evaluation part of study will be conducted as a 3-month, double-blind, parallel-group, placebo-controlled, single center study. The study population will include 30 ESKD patients receiving MHD treatment with different degrees of protein-energy wasting (PEW) defined as malnutrition-inflammation score (MIS) above 6. A total of 30 subjects will be randomized to treatment with either cannabis oil or matching placebo.