- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03471585
Effects of THC on Emotional Memory Retrieval (TARE)
May 28, 2019 updated by: University of Chicago
The Effects of Δ⁹-Tetrahydrocannabinol on the Retrieval of Emotional Memories
The main purpose of this study was to examine the effects of THC on the retrieval of emotional and neutral memories in healthy young adults.
Secondary experiments included the effects of THC on the encoding of object and scene stimuli and a novel working memory task.
Study Overview
Detailed Description
Here, the investigators aimed to investigate the effects of THC (15 mg) on the retrieval of negative, neutral, and positive memories.
The study used a placebo-controlled, within-subjects, crossover design with 24 participants.
In each experimental arm, participants attend a session to encode stimuli, a second session 48 hours later in which their memories are tested for the stimuli from the first session followed by the encoding of object-scene stimuli and a working memory test, and a third session 48 hours later in which memory for the object-scene stimuli is tested.
In the second session, two hours prior to memory testing, THC or placebo is administered.
On the first and second sessions subjects complete mood questionnaires.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 4-100 lifetime cannabis occasions
Exclusion Criteria:
- Current Axis I DSM-IV disorder, including substance dependence, current use of >5 cigarettes per day, history of psychosis or mania, less than a high school education, lack of English fluency, a body mass index outside 19-33 kg/m2, high blood pressure (>140/90), abnormal electrocardiogram, daily use of any medication other than birth control, pregnancy, or lactating.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo oral capsule
Participants came in for the first session that involved encoding emotional pictures and lists of semantically related words (Deese-Roediger-McDermott or DRM task; a false memory task).
Forty-eight hours later, participants received a placebo capsule (dextrose) and waited 2 hours Participants were monitored for the next 2 hours including physiological and subjective measures every 30 minutes.
After 2 hours, participants' memory for the emotional stimuli and DRM stimuli was tested.
Participants then encoded object stimuli overlaid onto scenes followed by a working memory test with simple color squares.
After the memory tests and 3.5 hours post-capsule, if participants' physiological and subjective measures had returned to baseline, they were allowed to leave.
Forty-eight hours later, memory for the object-scene stimuli was tested.
Other than the capsule, this arm was identical to the THC arm.
|
A capsule that contains only dextrose filler administered 2 hours prior to memory testing.
Other Names:
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Experimental: THC
Participants came in for the first session that involved encoding emotional pictures and lists of semantically related words (Deese-Roediger-McDermott or DRM task; a false memory task).
Forty-eight hours later, participants received a placebo capsule (dextrose) and waited 2 hours Participants were monitored for the next 2 hours including physiological and subjective measures every 30 minutes.
After 2 hours, participants' memory for the emotional stimuli and DRM stimuli was tested.
Participants then encoded object stimuli overlaid onto scenes followed by a working memory test with simple color squares.
After the memory tests and 3.5 hours post-capsule, if participants' physiological and subjective measures had returned to baseline, they were allowed to leave.
Forty-eight hours later, memory for the object-scene stimuli was tested.
Other than the capsule, this arm was identical to the placebo arm.
|
A capsule that contains 15 mg of THC as well as dextrose filler administered 2 hours prior to memory testing.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotional Memory
Time Frame: Two hours after placebo/THC administration.
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Hit and false alarm rates for negative, neutral, and positive picture stimuli
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Two hours after placebo/THC administration.
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DRM Memory
Time Frame: Two and a half hours after placebo/THC administration.
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Hit and false alarm rates for the DRM task
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Two and a half hours after placebo/THC administration.
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Object Memory
Time Frame: 48 hours after placebo/THC administration.
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Hit and false alarm rates for object stimuli on the same or different encoding scenes
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48 hours after placebo/THC administration.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Addiction Research Centre Inventory Marijuana Scale
Time Frame: Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
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The Addiction Research Centre Inventory (ARCI; Martin, Sloan, Sapira, & Jasinski, 1971) measures drug-specific effects on a 56-item true-false questionnaire.
For this study, the investigators report the composite score of 12 questions that make up the marijuana scale (Chait, Fischman, & Schuster, 1985).
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Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
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Visual Analog Scales
Time Frame: Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
|
The Visual Analog Scales (VAS; Folstein & Luria, 1973) is composed of thirteen adjectives used to assess individual dimensions of subjective mood - anxious, stimulated, sedated, elated, insightful, sociable, confident, lonely, playful, dizzy, loving, friendly, and restless, rated on a sliding scale from 'not at all' to 'extremely.'
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Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
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Drug Effects Questionnaire
Time Frame: Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
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The Drug Effects Questionnaire (DEQ; Morean et al., 2013) is composed of five questions concerning current drug effects - how much participants feel a drug effect, like the effect, dislike the effect, feel high, and want more of the drug, rated on a sliding scale from 'not at all/neutral' to 'very much.'
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Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
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Physiological Measure 1
Time Frame: Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
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Heart rate
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Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
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Physiological Measure 2
Time Frame: Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
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Blood pressure
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Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David A Gallo, PhD, University of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Doss MK, Weafer J, Gallo DA, de Wit H. Delta9-Tetrahydrocannabinol During Encoding Impairs Perceptual Details yet Spares Context Effects on Episodic Memory. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Jan;5(1):110-118. doi: 10.1016/j.bpsc.2019.08.007. Epub 2019 Aug 30.
- Doss MK, Weafer J, Gallo DA, de Wit H. Delta9-Tetrahydrocannabinol at Retrieval Drives False Recollection of Neutral and Emotional Memories. Biol Psychiatry. 2018 Nov 15;84(10):743-750. doi: 10.1016/j.biopsych.2018.04.020. Epub 2018 May 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2017
Primary Completion (Actual)
October 4, 2017
Study Completion (Actual)
October 4, 2017
Study Registration Dates
First Submitted
March 7, 2018
First Submitted That Met QC Criteria
March 13, 2018
First Posted (Actual)
March 20, 2018
Study Record Updates
Last Update Posted (Actual)
May 30, 2019
Last Update Submitted That Met QC Criteria
May 28, 2019
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
Other Study ID Numbers
- IRB16-1132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The investigators have shared all of the data to https://osf.io/e6b5k/
IPD Sharing Time Frame
The data is already available.
IPD Sharing Access Criteria
Open to anyone.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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