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Cannabis clinical trials

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NCT ID: NCT01853020 Completed - Psychotic Disorders Clinical Trials

Cannabinoids and Cerebellar-Motor Functioning

Start date: December 2012
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.

NCT ID: NCT01620177 Completed - Alcohol Drinking Clinical Trials

Effects of Inhaled Cannabis on Driving Performance

Start date: July 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to expand understanding of the effects of cannabis on driving performance with and without the presence of low levels of alcohol. This project will involve the development a of a protocol and driving environment that is sensitive to the effects of cannabis on driving performance by building on prior driving situations used previously for testing the effects of alcohol on driving.

NCT ID: NCT01529047 Completed - Cannabis Clinical Trials

Web-based vs In-person Personalized Feedback Intervention for Comorbid Substance Use and Disordered Gambling

Start date: February 2010
Phase: N/A
Study type: Interventional

Rates of gambling and substance use behaviors are elevated among emerging adults (ages 18-24), and these behaviors are individually and jointly associated with a host of negative consequences. Evidence suggests there is significant overlap between these behaviors as well as comorbidity of associated mental disorders (i.e., pathological gambling and substance abuse/dependence). Prior research suggests that a brief in-person delivered personalized feedback intervention (PFI) may be an effective method of reducing these behaviors and their associated consequences among emerging adults. Thus, the purpose of this study is to determine the relative efficacy of an in-person delivered PFI versus a Web-based PFI in reducing gambling, alcohol and marijuana use behaviors and related-consequences in a sample of emerging adults, as well as explore potential moderators and mediators of intervention efficacy and the longevity of intervention effects (over a period of 18-months).

NCT ID: NCT01170260 Completed - Health Behavior Clinical Trials

Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents

MARS
Start date: August 2010
Phase: N/A
Study type: Interventional

This research is studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors.

NCT ID: NCT01167556 Enrolling by invitation - Schizophrenia Clinical Trials

Family Motivational Intervention in Schizophrenia

FMI
Start date: March 2006
Phase: N/A
Study type: Interventional

Cannabis use by people with schizophrenia is associated with family distress and poor clinical outcomes. Therefore, an Family Motivational Intervention (FMI) was developed to help parents to motivate their child with a diagnoses of recent-onset schizophrenia to reduce cannabis use. In a single-blind randomised clinical trail with 75 patients with the diagnosis of schizophrenia, parents will be assigned to either FMI or to routine care. Assessments will be conducted at baseline and at a 10- and 22-month follow-up. The study hypothesis is that FMI will be more effective than routine care in reducing (a) cannabis use in patients and (b) distress and sense of burden in parents.

NCT ID: NCT01041170 Completed - Cannabis Clinical Trials

Antagonist-Elicited Cannabis Withdrawal

Start date: April 16, 2006
Phase: Phase 1
Study type: Interventional

Background: Rimonabant, a CB1 receptor antagonist, blocks effects of cannabinoids and, in dependent animals, elicits cannabinoid withdrawal. No studies have examined rimonabantelicited cannabis withdrawal in humans. Goals: (1) Determine the lowest single dose of oral rimonabant that elicits measurable cannabinoid withdrawal. (2) Characterize cognitive performance, subjective state, physiological condition, and regional brain activation (measured by functional magnetic resonance imaging [fMRI]) during acute and chronic administration of oral delta 9-tetrahydrocannabinol (THC) and during cannabis withdrawal. (3) Characterize the pharmacokinetics of oral THC and metabolites in body fluids and hair and of rimonabant in plasma. Subject Population: Up to 60 completing cannabis users aged 18-45 (up to 24 in Experiment I, 36 in Experiment II) and 18 completing non-drug-using controls (Experiment II). Enrollment target is 82% Caucasian, 14% African American, 4% other; 9% Hispanic; 35% women. Experimental Design and Methods: Experiment I: In this within-subject, randomized, double-blind, dose-escalation study, six participants receive 7 days of THC (40-120 mg/day). On Day 8, five participants receive 20 mg rimonabant; one receives placebo. If withdrawal criteria (greater than or equal to 150% or 2.5-fold increase in selected visual-analog scales) are not met in all five participants receiving rimonabant, separate groups of six are similarly treated with 40, 60 or 80 mg rimonabant, if necessary. The PI and MRP will submit all adverse events and relevant cardiovascular and scientific data to the IRB at the completion of each rimonabant dose panel. When the extramural NIDA DSMB is in place, it will review all data collected to date and develop and implement a monitoring plan, including review on completion of each dose cohort. DSMB recommendations will be reviewed by the Sponsor, Clinical Director and IRB before proceeding to the next dose cohort. In addition, if any subject has an intolerable adverse event (ie, an adverse event leading to study discontinuation) or serious adverse event in response to rimonabant on Day 8, the blind for that subject will be broken, and a report sent to the Sponsor, the extramural NIDA DSMB when in place and the IRB for discussion. Experiment II: In this randomized, placebo-controlled, double-blind study, 36 participants receive 7 days of THC (40-120 mg/day). On Day 8, 18 participants receive rimonabant dose determined in Experiment I to elicit cannabis withdrawal; 18 participants receive placebo rimonabant to evaluate spontaneous cannabis withdrawal. Cognitive, psychological, physiological and hormonal measures are monitored to determine onset, magnitude, and duration of THC intoxication and withdrawal and to correlate with THC and rimonabant pharmacokinetics. Changes in blood oxygen level-dependent (BOLD) signal are determined with five fMRI scans throughout the study. Eighteen non-drug-using controls undergo scanning and cognitive testing at similar intervals. Risks and Benefits: The proposed doses of THC and rimonabant have been well tolerated in other studies. The most common side effects of oral THC are sedation, cognitive impairment, euphoria, poor coordination, tachycardia, and hypotension. Spontaneous withdrawal from cannabis is mild and medically benign. Experience with other drugs suggests that antagonist-elicited cannabis withdrawal may have an earlier onset and greater intensity than spontaneous cannabis withdrawal. There are no clinical benefits to participants. Scientific benefits are greater understanding of cannabis intoxication, tolerance, and withdrawal and of the role of rimonabant in eliciting cannabis withdrawal.

NCT ID: NCT01037608 Completed - Pharmacokinetics Clinical Trials

Effects of Sativex(Registered Trademark) and Oral THC on Attention, Affect, Working Memory, Reversal Learning, Physiology and Brain Activation

Start date: May 8, 2007
Phase: Phase 1
Study type: Interventional

Background: - The therapeutic modalities of cannabis have received more research attention recently with the discovery of its ability to stimulate appetite and to provide pain and nausea relief in patients with AIDS, cancer, and multiple sclerosis, among other diseases. Sativex(Registered Trademark), an experimental drug derived from the marijuana plant, contains tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which affect brain activity. Sativex(Registered Trademark) is being tested to determine how and to what extent it affects brain activity. - Functional magnetic resonance imaging (fMRI) uses magnetic waves to study brain activity. Researchers are interested in using fMRI to study how Sativex(Registered Trademark) affects regional brain activity, including thinking abilities and behavior. Objectives: - To study changes in regional brain activity produced by Sativex(Registered Trademark) compared with THC and placebo. - To determine how Sativex(Registered Trademark) is processed by the body. Eligibility: - Individuals between 18 and 45 years of age who are either current users of cannabis (less than daily) or healthy volunteers who do not use cannabis. Design: - The study will involve one training session and five testing sessions on separate days. - At every session, subjects will receive either THC or placebo capsules and either Sativex(Registered Trademark) or placebo spray. - Participants will complete a training session in a mock fMRI scanner to adapt to the fMRI scanning environment. In the training session, participants will practice the tests that will track thinking ability, attention, working memory, and other cognitive tasks. - Participants will have five fMRI scanning sessions with the tests they have practiced previously, and will provide blood, urine, and saliva samples as required by the researchers. Participants will be discharged approximately 12 hours after they arrive for the study sessions....

NCT ID: NCT00842985 Completed - Cannabis Clinical Trials

Dronabinol Interactions in Humans

Start date: September 2008
Phase: N/A
Study type: Interventional

Marijuana use is a major problem among veterans and non-veterans. A patient's use of marijuana while engaged in psychotherapy treatment may affect their memory and, therefore, limit their ability to benefit from treatment. This study is designed to test a new pharmacotherapy, modafinil, which has the potential to improve memory functioning in marijuana using individuals. We hypothesize that modafinil treatment will decrease ratings of drug liking and improve cognitive measures, especially episodic memory.

NCT ID: NCT00708994 Completed - Psychotic Disorders Clinical Trials

Cannabinoids, Neural Synchrony, and Information Processing

THC-Gamma
Start date: February 25, 2008
Phase: Early Phase 1
Study type: Interventional

The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active ingredient of cannabis, on neural synchrony. Neural synchrony is studied using electroencephalography (EEG).

NCT ID: NCT00176085 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH

Start date: October 2004
Phase: Phase 1
Study type: Observational

A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to now not conducted, except of one single experiment in which (lacking) psychopharmacological activity was tested after intravenous infusion of 20 mg in a human individual. In this study, however, the authors did not trace the above questions due to analytical and methodological deficits. Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after intravenous ad-ministration of 5 mg THCCOOH in healthy individuals