Tirzepatide til behandling af cannabisbrugsforstyrrelse
Tirzepatide til behandling af cannabisbrugsforstyrrelse: Et pilotforsøg med dobbeltblindt, placebokontrolleret, krydset design
This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder. Eligible participants will be scheduled in random order to receive either tirzepatide or placebo injection in double-blind fashion and cross-over design. Outcomes will be assessed at the following study visit. Washout period of at least 4 weeks will be required between tirzepatide or placebo injections. Primary outcome of interest is cue-induced craving to cannabis-related visual cues.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Mary R Shen, MD
- Telefonnummer: 6177325752
- E-mail: mshen4@bwh.harvard.edu
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- English speaking adults aged 18 and above
- Diagnosed with DSM-5 cannabis use disorder, severe
Exclusion Criteria:
- Active psychosis, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent
- Any current or lifetime diagnosis of eating disorders including anorexia, bulimia, binge eating or
- Comorbid substance use disorder
- BMI<21 kg/m2
- Current or lifetime diagnosis of Type 1 or Type 2 diabetes
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Use of any glucagon-like peptide -1 agonist medications in the prior 3 months
- Anticipating receipt of any glucagon-like peptide-1 agonist medications during the trial
- Current hypoglycemia as indicated by a blood sugar level of <71 mg/dL measured at baseline visit, as well as visits 2 and 4.
- Untreated cholelithiasis or gallbladder disease
- History of acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or congestive heart failure in the last 90 days
- Systolic blood pressure persistently above 160 mmHg or diastolic blood pressure persistently above 100 mmHg during screening
- History of inflammatory bowel disease, bariatric surgery, pancreatitis, diabetic gastroparesis, or non-arteritic anterior ischemic optic neuropathy
- Liver function test greater than 3 times upper normal limit
- Renal impairment as indicated by estimated glomerular filtration rate (eGFR) of <30
- History of hypersensitivity or allergy to tirzepatide
- Pregnant or breastfeeding
- Individuals taking glucagon-like peptide-1 agonists or other weight loss drugs.
- Anticipated to participate in a concurrent drug trial
- Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: tirzepatide
2.5mg subcutaneous injection once |
2.5mg subcutaneous injection once |
|
Placebo komparator: placebo
matching placebo subcutaneous injection once |
Saline placebo subcutaneous injection once |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cue-Induced Craving
Tidsramme: 5 weeks
|
Craving scores will be assessed using a cue-reactivity paradigm in which participants are exposed to cannabis]-related cues. Scores range from 0 to 30, with higher scores indicating greater craving intensity. |
5 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Serious adverse event
Tidsramme: 5 weeks
|
Incidence of serious adverse events |
5 weeks
|
|
Cravings
Tidsramme: 5 weeks
|
Cannabis craving scale using the 12-item questionnaire, each item scored on a 1-7 sale. Higher scores (either average or summed) indicates stronger cravings. |
5 weeks
|
|
Abstinence
Tidsramme: 5 weeks
|
Percent days abstinent from cannabis |
5 weeks
|
|
Weight
Tidsramme: 5 weeks
|
Weight |
5 weeks
|
|
Blood sugar
Tidsramme: 5 weeks
|
Blood glucose |
5 weeks
|
|
Hemoglobin A1c
Tidsramme: 5 weeks
|
Hemoglobin A1c |
5 weeks
|
|
Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8)
Tidsramme: 5 weeks
|
Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8). The PHQ-8 assesses depression severity over the past two weeks. Total scores range from 0 to 24, with higher scores indicating greater depression severity (worse outcome). Score interpretation: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-24 (severe depression). |
5 weeks
|
|
Anxiety severity as measured by the Generalized Anxiety Disorder-7 scale (GAD-7)
Tidsramme: 5 weeks
|
The GAD-7 assesses anxiety symptom severity over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity (worse outcome). Score interpretation: 0-4 (minimal anxiety), 5-9 (mild), 10-14 (moderate), 15-21 (severe anxiety). |
5 weeks
|
|
Suicidality as measured by the C-SSRS (Columbia-Suicide Severity Rating Scale)
Tidsramme: 5 weeks
|
The C-SSRS assesses the presence and severity of suicidal ideation and behavior. Suicidal ideation severity scores range from 0 to 5 (0=no ideation, 1=wish to be dead, 2=non-specific active suicidal thoughts, 3=active suicidal ideation with methods, 4=suicidal intent, 5=suicidal intent with plan), with higher scores indicating greater severity (worse outcome). The scale also captures suicidal behavior as binary yes/no responses. |
5 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Joji Suzuki, Brigham and Women's Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025P002984
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .