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Tirzepatide in the Treatment of Cannabis Use Disorder

29. Juni 2026 aktualisiert von: M. Van Ameringen, McMaster University

A 12-Week Phase 3 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Tirzepatide-Assisted-Psychotherapy in Adults With Cannabis Use Disorder: A Proof-of-Concept Study

Cannabis is the most commonly used psychoactive substance in Canada. A sub-group of cannabis users develop Cannabis Use Disorder (CUD). CUD is a pattern of cannabis use that results in impairment in functioning, symptoms of tolerance, withdrawal, and distress. Several pharmacological and psychosocial interventions have been evaluated for their efficacy in treating CUD, however they lack high success rates. GLP-1RA's have shown promising results in reducing food and alcohol cravings and intake. Tirzepatide acts as both a GLP-1RA and a glucose-dependent insulinotropic polypeptide receptor agonist. Tirzepatide has been reported to reduce alcohol consumption, and therefore may have promising effects as a treatment for CUD. This study aims to evaluate the feasibility and tolerability of weekly injections of Tirzepatide combined with Motivational Enhancement Therapy in adults with CUD. This trial will be the first to examine the potential therapeutic effects of Tirzepatide in CUD.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

15

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Kanada
    • Ontario
      • Hamilton, Ontario, Kanada, L8S 1B8
        • MacAnxiety Research Centre
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Adults aged 18 and above
  • DSM-5 Cannabis Use Disorder diagnosis of at least moderate severity (4+ DSM-5 symptoms)
  • 4 or more days of cannabis use per week
  • Treatment seeking
  • A Body Mass Index (BMI) ≥ 22

Exclusion Criteria:

  • Meet DSM-5 criteria for Cluster A or B personality disorders and/or unstable current bipolar disorder, schizophrenia, or psychotic disorder
  • Comorbid severe DSM-5 Major Depressive Disorder
  • Present a serious suicide risk or who are likely to require psychiatric hospitalization during the course of the study, as determined by the study physician and Columbia Suicide Severity Rating Scale
  • Any other mental health condition deemed incompatible by the study team
  • Meet DSM-5 criteria for alcohol or substance use disorder for any substance other than cannabis or tobacco in the past 6 months
  • Positive urine drug screen for any substance except cannabis
  • Concurrent addiction-focused psychotherapy in the past 6 months
  • Unstable management of an existing mental health condition or anticipation of a change to the treatment over the next 3 months
  • A personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
  • Current unstable medical condition
  • A lifetime diagnosis of Diabetes
  • Females who are pregnant/nursing, or individuals in reproductive age who do not consent to using birth control during the study
  • Concomitant treatment with: other GLP-1 agonists, Contrave, bupropion, naltrexone, acamprosate within the past year. No lifetime treatment with tirzepatide.
  • Significant literacy, visual, or hearing problems
  • Co-enrollment in a clinical drug trial

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Single Arm
This is an open-label single arm intervention. All participants will be offered both Tirzepatide and psychotherapy over the 12-week treatment period.
Arzneimittel: Tirzepatide
Treatment will occur over a 12-week period, with once-weekly injections of escalating doses every 3 weeks from 2.5mg to 10mg. Tirzepatide will be used in conjunction with Motivational Enhancement Therapy (MET).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Tolerability of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.
Zeitfenster: From baseline to 12-week endpoint.

Tolerability will be measured by the percent of participants who discontinue the trial.

Tolerability will also be measured by the percent of participants who reach the target dose.
From baseline to 12-week endpoint.
Feasibility of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.
Zeitfenster: From baseline to 12-week endpoint.
Feasibility will be evaluated based on the number of people who contact the study team, percent of people that contact who are eligible and percent of eligible participants who enroll.
From baseline to 12-week endpoint.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Frequency and amount of cannabis use
Zeitfenster: From baseline to 12-week endpoint.
The Enhanced Cannabis Timeline Follow Back (EC-TLFB) obtains information about frequency of cannabis use, amount used, types of cannabis products, and methods of administration.
From baseline to 12-week endpoint.
Severity of Cannabis Use Disorder symptoms
Zeitfenster: From baseline to 12-week endpoint
The Self-Reported Symptoms of Cannabis Use Disorder (SRSCUD) is a 13-item self-report form that allows individuals to rate the severity of their Cannabis Use Disorder on a scale from 1 to 4. Total scores range from 0 to 39, with a higher score indicating greater symptom severity.
From baseline to 12-week endpoint
Cannabis cravings
Zeitfenster: From baseline to 12-week endpoint
The Marijuana Craving Questionnaire - Short Form (MCQ-SF) is a self-report 12-item questionnaire used to assess individual's cannabis craving experiences.
From baseline to 12-week endpoint
Cannabis withdrawal symptoms
Zeitfenster: From baseline to 12-week endpoint
The Marijuana Withdrawal Checklist (MWC) is a self-report 15-item questionnaire used to assess symptoms of cannabis withdrawal. Participants rate items on a Likert scale from 0 (not at all) to 3 (severe) based on their most recent period of cannabis abstinence. Scores range from 0 to 45, with higher scores indicating greater withdrawal symptom severity.
From baseline to 12-week endpoint

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline on Attention Deficit Hyperactivity Disorder symptom severity
Zeitfenster: From baseline to 12-week endpoint
The Barkley's Adult ADHD Rating Scale - I (BAARS-IV) is a 21 item self-report questionnaire that assesses ADHD symptom severity.
From baseline to 12-week endpoint
Change from baseline in OCD symptoms
Zeitfenster: From baseline to 12-week endpoint.
The Obsessive Compulsive Inventory - Revised (OCI-R) is an 18-item self-report questionnaire that assesses various obsessions.
From baseline to 12-week endpoint.
Change from baseline on the severity of anxiety symptoms
Zeitfenster: From baseline to 12-week endpoint
The Generalized Anxiety Disorder-7 (GAD-7) is a self-report 7-item questionnaire that measures anxiety symptom severity. Items are rated on a Likert scale from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating greater symptom severity.
From baseline to 12-week endpoint
Change from baseline in depression symptoms
Zeitfenster: From baseline to 12-week endpoint.
The Patient Health Questionnaire-9 (PHQ-9) is a self-report measure with 9-items used to assess the presence of depression symptoms in the past 2 weeks. Items are scored on a Likert scale from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating greater depression severity.
From baseline to 12-week endpoint.
Change from baseline in functional impairment
Zeitfenster: From baseline to 12-week endpoint.
The Sheehan Disability Scale (SDS) is a self-report scale of functional impairment. Responses are based on an eleven-point scale from 0 (not at all) to 10 (extremely). Total scores range from 0 to 30, with higher scores indicating greater impairment.
From baseline to 12-week endpoint.
Change in baseline quality of life
Zeitfenster: From baseline to 12-point endpoint.
The World Health Organization Quality of Life assessment (WHOQOL-BREF) is a self-report measure that assesses quality of life across physical health, psychological, social relationships, and environment domains. The WHOQOL-BREF consists of 26 items that are rated on a 5-point Likert scale. Scores are transformed to range from 0 to 100, with higher scores indicating better quality of life.
From baseline to 12-point endpoint.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

McMaster University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

31. Juli 2028

Studienabschluss (Geschätzt)

31. Juli 2028

Studienanmeldedaten

Zuerst eingereicht

15. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2026

Zuerst gepostet (Tatsächlich)

26. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Tirzep_CUD

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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