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Cannabis Observations on Brain Waves, Retrieval, and Attention: Experiment 4 (COBRA 4)

29 de junio de 2026 actualizado por: L. Cinnamon Bidwell

Cannabis and Memory

This study investigates the impact of ∆9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on recognition memory in healthy, regular cannabis users. Participants complete the same recognition memory task after self-administering one of two different strains of cannabis flower one day and while not intoxicated another day. Event-related potentials (ERPs) are measured via electroencephalogram (EEG) during the recognition memory task. Blood is collected to quantify THC and CBD exposure. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Previous research has established cannabis's harmful cognitive impact, with particularly robust and consistent effects in the domain of episodic memory. However, prior work has not sufficiently considered that the memory effects of cannabis are the compound action of different cannabinoids, which vary in their pharmacology and effects. Specifically, CBD, a non-psychotomimetic component of cannabis (doesn't produce a "high"), is thought to have cognitively protective properties and may mitigate some of the harmful effects of THC. Further, few prior studies have tested the effects of high potency strains that are commonly available.

This study tests the effects of commercially available cannabis flower strains on recognition memory performance and ERPs that are related to different underlying memory processes in healthy, regular cannabis users. An episodic memory task is used to assess recognition memory, which asks participants to discriminate between previously studied and non-studied items using pictures as stimuli. Participants complete the same memory task while intoxicated one day and not intoxicated another day. A THC-dominant strain and a strain containing both THC and CBD are included in the study. Participants self-administer one of the two cannabis strains prior to memory encoding and retrieval.

Blood is collected to determine THC and CBD exposure, as well as to explore how genetic variation in genes related to cannabinoid metabolism, cannabis-related behavior, and neurocognitive function associate with memory function before and after cannabis use. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

Tipo de estudio

De observación

Inscripción (Estimado)

64

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Colorado
      • Boulder, Colorado, Estados Unidos, 80301
        • Reclutamiento
        • Center for Innovation and Creativity (CINC)
        • Contacto:
        • Investigador principal:
          • Timothy Curran, Ph.D.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

Community sample of healthy, regular cannabis users in the Boulder/Denver areas.

Descripción

  1. Must be between the ages of 21 and 40 and provide informed consent;
  2. Must be right-handed (Laterality Quotient > 60 on Edinburgh Handedness Inventory - Short Form136);
  3. Heavy users (HU) in Experiments 1, 2, 3, and 4:

    1. Must use cannabis at least 4 days during the month;
    2. Must be a cannabis user for at least a year;
  4. Non-users (NU) in Experiment 2:

    1. Must not have used cannabis for prior 6 months;
    2. Must have at least one episode of lifetime cannabis use;
  5. Must self-report not using other illicit recreational drugs (e.g., cocaine, benzodiazepines (non-prescription), opiates (non-prescription), MDMA, sedatives, or methamphetamine) in the past 30 days, during the Pre-Screening;
  6. Must not test positive on a urine toxicology test for drugs of abuse at the Baseline Appointment (TDS);
  7. Must not be using psychotropic medications, however anti-depressant, non-benzodiazepine anti-anxiety, and ADHD medications are ok. ADHD medication users must be willing to abstain from ADHD medication use on appointment days; ADHD medications, even extended-release forms, are short acting and medication" holidays" (e.g., on weekends and holidays) are routine in individuals prescribed ADHD medications, without adverse effects.
  8. Must not be a regular nicotine user (≤4 days per week; cigarette, E-cigs, or smokeless);
  9. Must not have used caffeine or nicotine (cigarette, E-cigs, or smokeless) for 4 hours;
  10. Must have a breath alcohol level of 0 at screening (to sign consent form);
  11. Must not be actively seeking or in treatment for any substance use disorder (drug use levels will be carefully monitored via Timeline Follow Back (TLFB) throughout the study to assess any confounding influences of drug or alcohol use;
  12. Female subjects must not be or trying to become pregnant (as indicated by a pregnancy test & screening form administered at Baseline);
  13. Must not be in treatment for psychotic disorder or bipolar disorder; or have a history with these disorders;
  14. Must not have any physical characteristics (e.g., thick hair, head size exceeding the limit of the net, dyed hair) or experience any technical difficulties during testing that result in a poor-quality EEG recording.
  15. Participants in Experiment 4 a. Must not have participated in Experiment 3

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in ERP amplitude (FN400)
Periodo de tiempo: Intoxicated session and not-intoxicated session (about 1 week)
The FN400 event-related potential (ERP) old/new effect will be measured using electroencephalography (EEG) during a recognition memory test. The FN400 reflects familiarity-based memory retrieval and is defined as the mean ERP amplitude difference between correctly recognized previously presented items ("hits") and correctly rejected novel items ("correct rejections") at mid-frontal electrode sites during the 300-500ms post-stimulus interval.
Intoxicated session and not-intoxicated session (about 1 week)
Difference in ERP amplitude (parietal)
Periodo de tiempo: Intoxicated session and not-intoxicated session (about 1 week)
The parietal ERP old/new effect will be measured using EEG during a recognition memory test. The parietal old/new effect reflects recollection-based memory retrieval and is defined as the mean ERP amplitude difference between hits and correct rejections at parietal electrode sites during the 500-800ms post-stimulus interval.
Intoxicated session and not-intoxicated session (about 1 week)
Difference in retrieval memory accuracy
Periodo de tiempo: Intoxicated session and not-intoxicated session (about 1 week)
Behavioral accuracy during recognition memory test will be assessed by the number of hits and correct rejections made during memory recall. Retrieval memory accuracy will be compared between intoxicated and not-intoxicated sessions.
Intoxicated session and not-intoxicated session (about 1 week)
Difference in retrieval memory performance
Periodo de tiempo: Intoxicated session and not-intoxicated session (about 1 week)
Memory performance will be assessed via reaction time, measured by a photocell during recognition memory testing and concurrent EEG. During the recall phase, a light indicator will appear in the bottom-right corner of the stimulus screen when a prompted image is presented, activating the photocell. This indicator disappears once the participant responds. The interval between stimulus onset and the participant's "new" or "old" response is used as the reaction time measure for both intoxicated and non-intoxicated sessions. Retrieval memory performance will be compared between intoxicated and not-intoxicated sessions.
Intoxicated session and not-intoxicated session (about 1 week)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Positive and Negative Affect Schedule (PANAS)
Periodo de tiempo: During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
The PANAS is a Self-report measurement of positive and negative affect that will be administered at all times of the Mobile sessions: the pre-use and post-use timepoints of the intoxicated session, well as the not-intoxicated session. The PANAS will be used twice at the intoxicated session to measure changes in mood before and after cannabis use. The survey presents a 20-item scale from 1 (very slightly or not at all) to 5 (extremely), with a higher score on the positive affect scale indicating higher positive affect and a higher score on the negative affect scale indicating higher negative affect.
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
Change in Drug Effects Questionnaire (DEQ)
Periodo de tiempo: During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
The DEQ is a 5-item visual analogue scale that measures acute drug effects, with prevalent use across numerous drug studies. Specifically, the questionnaire measures strength of the effects of cannabis as well as the desirability of the effects. Participants answer questions on a range from 0 - 100, with higher values for each item indicating greater drug effect or desire. The specific items related to drug "liking" and "wanting more" have been associated with harmful drug use. Participants will be administered the DEQ at all time points of the Mobile sessions to assess differences following intoxication.
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
Change in Addiction Research Center Inventory (ARCI-M)
Periodo de tiempo: During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
The ARCI-M is a self-report measure of subjective effects of marijuana in addition to drug-induced euphoria, stimulant-like effects, intellectual efficiency and energy, sedation, dysphoria, and other somatic effects. This is a 12 item true-false task, in which higher (true) scores indicate greater intoxication. Participants will be administered the ARCI-M at all time points of the Mobile sessions to assess differences following intoxication.
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
Change in Marijuana Craving Questionnaire (MCQ)
Periodo de tiempo: During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
The Marijuana Craving Questionnaire is a self-report measure of marijuana craving that will be administered at all time points during the Mobile sessions. Participants complete 8 questions ranging from 0 - 10, with a higher score indicating greater cannabis craving and somatic symptoms. The primary focus of this questionnaire will be the effect of intoxication on reporting.
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
Change in Profile of Mood States (POMS)
Periodo de tiempo: During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
The POMS is a self-report measure of mood. Participants complete 27 mood-related items ranging from 0 - 4, with higher scores indicating greater levels of specific mood states. The POMS will be administered at all time points of the Mobile sessions, in order to measure changes in mood before and after intoxication.
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
Change in Alcohol Craving Questionnaire (ACQ)
Periodo de tiempo: During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
The Alcohol Craving Questionnaire is a self-report measure of alcohol craving. This is a 2-item scale with each item ranging 0 - 10, with higher scores indicating greater alcohol craving. The ACQ is used at all time points of the Mobile sessions.
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
Change in State Adapted Paranoia Checklist-Brief (SAPC-B)
Periodo de tiempo: During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
The SAPC-B is a self-report measure of paranoia. Participants complete 5 items each ranging from 0 - 10, with higher scores indicating greater feelings of paranoia. The SAPC-B is administered at all time points of the Mobile sessions to assess changes in paranoia after intoxication.
During a single non-intoxicated laboratory session and immediately before and immediately after acute cannabis use during a single intoxicated laboratory session
Difference in circulating cannabinoid concentration
Periodo de tiempo: Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
Participants use cannabis ad-libitum. Therefore, blood levels of THC and CBD will be used to quantify dosage and compared across the not-intoxicated, pre-use and post-use time points of the Mobile sessions. This further allows for a direct test of whether any differences in outcomes for participants randomly assigned to the -THC/+CBD strain are due to an increase in CBD or a decrease in THC as compared to their baseline.
Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Exploratory: Correlations between genes related to cannabinoid metabolism, cannabis-related behavior, and neurocognitive function with ERPs and recognition memory performance
Periodo de tiempo: Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
DNA will be extracted from 3.0 ml of blood from the baseline session. After extraction, DNA will be quantified and stored at -80° for analysis. DNA will be collected to look at differences in epigenetic and single nucleotide polymorphisms (SNPs) in participants. Due to the rapidly changing landscape of genetic science, the DNA samples collected in this study are primarily for bio-banking purposes. The analysis of these genetic samples is expected to be performed at a future date to contribute to the current study and/or future studies. Participants will be allowed to opt out of storage of genetic samples for future research.
Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
Exploratory: Moderation of primary effects by baseline sleep quality using the Patient-Reported Outcomes Measurement Information Systems (PROMIS)
Periodo de tiempo: Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
Baseline measurement of sleep disturbance, assessing participant's quality and patterns of sleep over the last seven days. Participants complete 4 items, for a total scale score from 4 - 20, with higher scores indicating more sleep disturbance.
Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
Exploratory: Moderation of primary effects by baseline affective symptoms using the Depression Anxiety Stress Scale (DASS)
Periodo de tiempo: Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
Baseline assessment of affective symptoms. Participants complete the Depression, Anxiety, and Stress Scale-21 (DASS-21), a 21-item measure consisting of three 7-item subscales assessing depression, anxiety, and stress/tension. Higher scores indicate greater symptom severity within each domain. Acute drug-effect measures will be collected at each study session, including before and after participants self-administer their assigned cannabis strain during mobile laboratory sessions.
Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
Exploratory: Moderation of primary effects by baseline substance use history using the Timeline Followback (TLFB)
Periodo de tiempo: Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)
The TLFB is used to assess daily substance use for 30 days prior to the Baseline Appointment and 3-7 days prior to the later sessions. Our modified TLFB procedure will estimate both frequency of marijuana use and amount used per day, using visual stimuli as well as the method of administration.
Baseline, intoxicated session, and not-intoxicated session (about 3 weeks total over all three sessions)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Timothy Curran, Ph.D., University of Colorado, Boulder

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de diciembre de 2025

Finalización primaria (Estimado)

1 de febrero de 2027

Finalización del estudio (Estimado)

31 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

18 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de junio de 2026

Publicado por primera vez (Actual)

1 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 20-0309: Experiment 4
  • R01DA052431 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .