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Disturbo da uso di cannabis da densità SV2A

2 novembre 2026 aggiornato da: Deepak C. D'Souza, Yale University

The main purpose of this study is to determine whether hippocampal synaptic vesicle density estimated by hippocampal [11C]APP-311/[11C]UCB-J binding in individuals diagnosed with cannabis use disorder (CUDs) improves with at least 4 weeks of confirmed abstinence from cannabis, in comparison to healthy controls (HCs). Furthermore, any change in synaptic vesicle density will be placed in functional context by measuring verbal memory, which is sensitive to hippocampal function, before and after at least 4 weeks of confirmed abstinence. Finally, the relationship between hippocampal [11C]UCB-J binding in CUDs with measures of cannabis exposure (e.g., age of initiation, cumulative lifetime dose) will be explored.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

42

Fase

  • Prima fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06511
        • Yale University School of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

CUD Participants Inclusion Criteria:

  1. Able to provide informed consent
  2. Male and female 18-75 years old
  3. Daily cannabis use
  4. Positive urine screen for cannabinoids and negative for all other drugs on
  5. Diagnosis of DSM-5 cannabis use disorder (≥ moderate, i.e., ≥ 4 [of 11] symptoms).
  6. Must express a willingness at screening to set a date to attempt to quit using cannabis.
  7. Physically healthy i.e., no clinically unstable medical conditions.
  8. For women of childbearing potential (WOCBP) and men, willingness to practice birth control and to inform study staff immediately if either they (for women) or their partner (for men) becomes pregnant.
  9. Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.

CUD Participants Exclusion Criteria:

  1. Laboratory tests with clinically significant abnormalities or positive urine toxicology screen with exception of cannabinoids.
  2. Women with a positive pregnancy test or women who are lactating.
  3. Have implanted or embedded metal objects or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field
  4. Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
  5. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto) Subjects who have donated blood within 8 weeks of the present study
  6. Medications that could alter synaptic density and, therefore, confound the interpretation of study data.
  7. Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.

Healthy Controls Inclusion Criteria:

  1. Willing and able to give voluntary written informed consent
  2. Male and Female subjects, age 18 to 75 years, inclusive
  3. BMI within 19 to 35 kg/m2, inclusive
  4. Must be in good health as determined by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests.
  5. Negative urine drug screen
  6. If female, not pregnant or breastfeeding
  7. If female of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study and up to one month after completion of PET scans.
  8. Able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the clinic staff.
  9. Have arterial access sufficient to allow blood sampling as per the protocol.

Healthy Controls Exclusion Criteria:

  1. History or presence of clinically significant and unstable respiratory, GI, renal, hepatic, pancreatic, hematological, neurological (including history of seizure), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders, including all cancers.
  2. Abnormal clinically significant laboratory or physical findings during screening
  3. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto)
  4. A condition that, in the opinion of the investigator, would prevent compliance with the study protocol.
  5. Medications that could alter synaptic density and, therefore, confound the interpretation of study data.
  6. MRI incompatible implants and other contraindications for MRI, such as pace-maker, artificial joints, non-removable body piercings, metal fragments in head and/or body, or history working with ferrous metals either as a vocation or hobby in such a way that might have led to unknown, indwelling metal fragments that could cause injury during MRI etc.
  7. Subjects who suffer from claustrophobia.
  8. Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for healthy volunteers
  9. Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: CUD Group

Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart. CUD participants will be asked to abstain from cannabis for the 4 week period.

For each [11C]APP311 (UCB-J) PET scan, up to 20 mCi of [11C]APP311 (UCB-J) will be administered by infusion pump. All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart. Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan.

Comparatore attivo: Healthy Controls

Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart.

For each [11C]APP311 (UCB-J) PET scan, up to 20 mCi of [11C]APP311 (UCB-J) will be administered by infusion pump. All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart. Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hippocampal SV2A synaptic density
Lasso di tempo: All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart.

Hippocampal SV2A synaptic density will be measured using [11C]APP311 (UCB-J).

All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hippocampal binding and Hippocampal Verbal Memory Task
Lasso di tempo: The Auditory Verbal Learning Task (AVLT) will be administered before and after the 4 week abstinence period.

To determine the relationship between hippocampal [11C]APP311 (UCB-J) binding and performance on the hippocampal verbal memory task (Auditory Verbal Learning Task [AVLT]), a cognitive task that measures total immediate recall, before and after 4 weeks of confirmed cannabis abstinence.

The Auditory Verbal Learning Task (AVLT) will be administered before and after the 4 week abstinence period.
Hippocampal binding and Groton Maze Learning in CUDs
Lasso di tempo: The Groton Maze Learning Task will be administered before and after the 4 week abstinence period.

To determine the relationship between hippocampal [11C]APP311 (UCB-J) binding and performance on the Groton Maze Learning task, a cognitive task that measures total number of errors, in CUDs before and after 4 weeks of confirmed cannabis abstinence.

The Groton Maze Learning Task will be administered before and after the 4 week abstinence period.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Hippocampal synaptic density and first age of cannabis exposure
Lasso di tempo: Before and after the 4 week abstinence period.

To determine the relationship between hippocampal synaptic density (n=26+12 historical data) and indices of cannabis exposure such as first age of cannabis exposure, as measured by self-report data.

Before and after the 4 week abstinence period.
Hippocampal synaptic density and cumulative lifetime cannabis exposure.
Lasso di tempo: Before and after the 4 week abstinence period.

To determine the relationship between hippocampal synaptic density (n=26+12 historical data) and indices of cannabis exposure such as cumulative lifetime cannabis exposure, as measured by self-report data.

Before and after the 4 week abstinence period.
Hippocampal SV2A synaptic density after 8 weeks
Lasso di tempo: Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan. (8 weeks in total).

To explore whether hippocampal synaptic density and function continues to improve with 8 weeks of abstinence in a subset of CUD participants using [11C]APP311 (UCB-J).

Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan. (8 weeks in total).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Deepak C D'Souza, Yale University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 aprile 2022

Completamento primario (Effettivo)

28 aprile 2026

Completamento dello studio (Effettivo)

14 maggio 2026

Date di iscrizione allo studio

Primo inviato

14 luglio 2022

Primo inviato che soddisfa i criteri di controllo qualità

20 luglio 2022

Primo Inserito (Effettivo)

25 luglio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2000032181
  • 1R01DA054314 (Sovvenzione/contratto NIH degli Stati Uniti)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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