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HealthyEarly Phase 1TARENCT03471585

Effects of THC on Emotional Memory Retrieval

A Early Phase 1 study testing THC in people with Healthy, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
THC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
15 Feb 2017to 4 Oct 2017
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 4-100 lifetime cannabis occasions

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
THC, Placebo oral capsule
Keywords
THC, adult

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THCDrug

    Also called Marinol

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

  • Placebo oral capsuleDrug

    Also called Dextrose

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

Study groups in NCT03471585
Study groupRoleWhat they receive
Placebo oral capsulePlacebo comparatorParticipants 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.
Receives: Drug: Placebo oral capsule
THCExperimentalParticipants 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.
Receives: Drug: THC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emotional Memory

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

    Measured: Two hours after placebo/THC administration.

  2. DRM Memory

    Hit and false alarm rates for the DRM task

    Measured: Two and a half hours after placebo/THC administration.

  3. Object Memory

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

    Measured: 48 hours after placebo/THC administration.

Secondary outcomes (5)

  1. Addiction Research Centre Inventory Marijuana Scale

    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).

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

  2. Visual Analog Scales

    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.'

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

  3. Drug Effects Questionnaire

    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.'

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

  4. Physiological Measure 1

    Heart rate

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

  5. Physiological Measure 2

    Blood pressure

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2018
  2. Study start15 Feb 2017
  3. Primary completion4 Oct 2017
  4. Study completion4 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03471585
Sponsor's protocol ID
IRB16-1132
Acronym
TARE
Status last verified
Mar 2018
First submitted
7 Mar 2018
Last updated
30 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The investigators have shared all of the data to https://osf.io/e6b5k/

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.

    PubMed 31668830

  • 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.

    PubMed 29884456

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing THC in people with Healthy, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotional Memory (time frame: Two hours after placebo/THC administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03471585, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.

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