Tirzepatide for the Treatment of Cannabis Use Disorder

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English speaking adults aged 18 and above

Diagnosed with DSM-5 cannabis use disorder, severe

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Tirzepatide

    Drug

    2.5mg subcutaneous injection once

  • Placebo

    Drug

    Saline placebo subcutaneous injection once

Treatment groups

6 Participants
are divided into 2 treatment groups
Group A: tirzepatideExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cue-Induced Craving

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.

Time frame
5 weeks

Secondary outcomes

1

Serious adverse event

Incidence of serious adverse events

Time frame
5 weeks
2

Cravings

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.

Time frame
5 weeks
3

Abstinence

Percent days abstinent from cannabis

Time frame
5 weeks
4

Weight

Weight

Time frame
5 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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