Cannabinoids, Learning, and Memory (THC-Memory)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Connecticut
-
West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: THC
Active THC (0.0015mg/kg-0.03mg/kg)
administered over 20 minutes.
|
Active THC (0.0015-0.03 mg/kg) administered over 20 minutes.
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.
|
Active THC (0.0015-0.03 mg/kg) administered over 20 minutes.
Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rey Auditory Verbal Learning Test (RAVLT)
Time Frame: +35 minutes after infusion
|
a measure of verbal episodic memory
|
+35 minutes after infusion
|
|
N-Back Task
Time Frame: +65 minutes after infusion
|
a measure of working memory
|
+65 minutes after infusion
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician Administered Dissociative Symptoms Scale (Total Score)
Time Frame: Baseline, +10, +85, and +240 minutes after the first infusion
|
Baseline, +10, +85, and +240 minutes after the first infusion
|
|
|
Visual Analog Scale (Total Score)
Time Frame: Baseline, +10, +85, +240 minutes after the first infusion
|
a measure of THC intoxication
|
Baseline, +10, +85, +240 minutes after the first infusion
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Mohini Ranganathan, M.D., Assistant Professor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1501015211
- No NIH funding (Other Identifier: 11.16.23)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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