Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of THC on Emotional Memory Retrieval (TARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03471585
Recruitment Status : Completed
First Posted : March 20, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: THC Drug: Placebo oral capsule Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Half of the participants will receive placebo during the second session in the first experimental arm and THC during the second session in the second experimental arm. The other half of participants will receive THC during the second session in the first experimental arm and placebo during the second session in the second experimental arm.
Masking: Double (Participant, Investigator)
Masking Description: A lab member that knew the design of the study but was not running participants sorted placebo and THC capsules into bags labeled "first capsule and "second capsule" for each participant.
Primary Purpose: Basic Science
Official Title: The Effects of Δ⁹-Tetrahydrocannabinol on the Retrieval of Emotional Memories
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : October 4, 2017
Actual Study Completion Date : October 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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.
Drug: Placebo oral capsule
A capsule that contains only dextrose filler administered 2 hours prior to memory testing.
Other Name: Dextrose

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.
Drug: THC
A capsule that contains 15 mg of THC as well as dextrose filler administered 2 hours prior to memory testing.
Other Name: Marinol




Primary Outcome Measures :
  1. Emotional Memory [ Time Frame: Two hours after placebo/THC administration. ]
    Hit and false alarm rates for negative, neutral, and positive picture stimuli

  2. DRM Memory [ Time Frame: Two and a half hours after placebo/THC administration. ]
    Hit and false alarm rates for the DRM task

  3. Object Memory [ Time Frame: 48 hours after placebo/THC administration. ]
    Hit and false alarm rates for object stimuli on the same or different encoding scenes


Secondary Outcome Measures :
  1. 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. ]
    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).

  2. 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.'

  3. 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. ]
    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.'

  4. 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. ]
    Heart rate

  5. 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. ]
    Blood pressure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03471585


Locations
Layout table for location information
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Layout table for investigator information
Principal Investigator: Harriet de Wit, PhD University of Chicago
Principal Investigator: David A Gallo, PhD University of Chicago
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03471585    
Other Study ID Numbers: IRB16-1132
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators have shared all of the data to https://osf.io/e6b5k/
Time Frame: The data is already available.
Access Criteria: Open to anyone.
URL: https://osf.io/e6b5k/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
THC
adult
Additional relevant MeSH terms:
Layout table for MeSH terms
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists