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Trial record 6 of 54 for:    Recruiting, Not yet recruiting, Available Studies | NOT (Use Disorders OR Marijuana Use OR Dependence OR Abuse OR Drug Use) | cannabinoids

Cannabinoids, Learning, and Memory (THC-Memory)

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ClinicalTrials.gov Identifier: NCT02407808
Recruitment Status : Recruiting
First Posted : April 3, 2015
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

Brief Summary:
The overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.

Condition or disease Intervention/treatment Phase
Cannabis Psychotic Disorders Drug: THC Drug: Placebo Phase 1

Detailed Description:
This study will be achieved by studying the acute effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive component of cannabis and a cannabinoid-1 receptor (CB1R) agonist, on a wide range of memory tasks in healthy human subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cannabinoids, Learning, and Memory
Study Start Date : February 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: THC
Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.
Drug: THC
Active THC (0.0015-0.03 mg/kg) administered over 20 minutes.

Drug: Placebo
Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.

Placebo Comparator: Placebo
Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.
Drug: THC
Active THC (0.0015-0.03 mg/kg) administered over 20 minutes.

Drug: Placebo
Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.




Primary Outcome Measures :
  1. Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: +35 minutes after infusion ]
    a measure of verbal episodic memory

  2. N-Back Task [ Time Frame: +65 minutes after infusion ]
    a measure of working memory


Secondary Outcome Measures :
  1. Clinician Administered Dissociative Symptoms Scale (Total Score) [ Time Frame: Baseline, +10, +85, and +240 minutes after the first infusion ]
  2. Visual Analog Scale (Total Score) [ Time Frame: Baseline, +10, +85, +240 minutes after the first infusion ]
    a measure of THC intoxication



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged 18 and 55 years (extremes included) on day of first dosing
  • Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

  • Cannabis naive
  • Positive pregnancy screen during screening
  • Hearing deficits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407808


Contacts
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Contact: Christina Luddy, BS 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
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United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Mohini Ranganathan, M.D. Assistant Professor

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Responsible Party: Mohini Ranganathan, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT02407808     History of Changes
Other Study ID Numbers: 1501015211
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders