NCT03471585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1 healthy

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
Last Updated

May 30, 2019

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

March 7, 2018

Last Update Submit

May 28, 2019

Conditions

Healthy

Keywords

THCadult

Outcome Measures

Primary Outcomes (3)

  • Emotional Memory

    Hit and false alarm rates for negative, neutral, and positive picture stimuli

    Two hours after placebo/THC administration.

  • DRM Memory

    Hit and false alarm rates for the DRM task

    Two and a half hours after placebo/THC administration.

  • Object Memory

    Hit and false alarm rates for object stimuli on the same or different encoding scenes

    48 hours after placebo/THC administration.

Secondary Outcomes (5)

  • Addiction Research Centre Inventory Marijuana Scale

    Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.

  • Visual Analog Scales

    Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.

  • Drug Effects Questionnaire

    Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.

  • Physiological Measure 1

    Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.

  • Physiological Measure 2

    Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.

Study Arms (2)

Placebo oral capsule

PLACEBO COMPARATOR

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

THC

EXPERIMENTAL

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

Interventions

THCDRUG

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

Also known as: Marinol
THC
Placebo oral capsuleDRUG

A capsule that contains only dextrose filler administered 2 hours prior to memory testing.

Also known as: Dextrose
Placebo oral capsule

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • lifetime cannabis occasions

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

  • 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.

    PMID: 31668830DERIVED

  • 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.

    PMID: 29884456DERIVED

MeSH Terms

Interventions

DronabinolGlucose

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic ChemicalsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Harriet de Wit, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

  • David A Gallo, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 20, 2018

Study Start

February 15, 2017

Primary Completion

October 4, 2017

Study Completion

October 4, 2017

Last Updated

May 30, 2019

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

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.
More information

Locations

US(1)