- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03471585
Effects of THC on Emotional Memory Retrieval (TARE)
28 maj 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Tidig fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Illinois
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Chicago, Illinois, Förenta staterna, 60637
- University of Chicago
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 35 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: 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.
Andra namn:
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Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Emotional Memory
Tidsram: Two hours after placebo/THC administration.
|
Hit and false alarm rates for negative, neutral, and positive picture stimuli
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Two hours after placebo/THC administration.
|
DRM Memory
Tidsram: Two and a half hours after placebo/THC administration.
|
Hit and false alarm rates for the DRM task
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Two and a half hours after placebo/THC administration.
|
Object Memory
Tidsram: 48 hours after placebo/THC administration.
|
Hit and false alarm rates for object stimuli on the same or different encoding scenes
|
48 hours after placebo/THC administration.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Addiction Research Centre Inventory Marijuana Scale
Tidsram: 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).
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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
Tidsram: 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.'
|
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
Tidsram: 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.'
|
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
Tidsram: 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.
|
Physiological Measure 2
Tidsram: Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
|
Blood pressure
|
Assessed just prior to placebo/THC administration and then 30 minutes, 60 minutes, 90 minutes, and 115 minutes after placebo/THC administration.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: David A Gallo, PhD, University of Chicago
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 februari 2017
Primärt slutförande (Faktisk)
4 oktober 2017
Avslutad studie (Faktisk)
4 oktober 2017
Studieregistreringsdatum
Först inskickad
7 mars 2018
Först inskickad som uppfyllde QC-kriterierna
13 mars 2018
Första postat (Faktisk)
20 mars 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 maj 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 maj 2019
Senast verifierad
1 mars 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Analgetika, icke-narkotiska
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Psykotropa droger
- Hallucinogener
- Cannabinoidreceptoragonister
- Cannabinoidreceptormodulatorer
- Dronabinol
Andra studie-ID-nummer
- IRB16-1132
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
The investigators have shared all of the data to https://osf.io/e6b5k/
Tidsram för IPD-delning
The data is already available.
Kriterier för IPD Sharing Access
Open to anyone.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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