This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6
2.5mg subcutaneous injection once
Saline placebo subcutaneous injection once
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
Serious adverse event
Incidence of serious adverse events
Time frame: 5 weeks
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
Abstinence
Percent days abstinent from cannabis
Time frame: 5 weeks
Weight
Weight
Time frame: 5 weeks
Blood sugar
Blood glucose
Time frame: 5 weeks
Hemoglobin A1c
Hemoglobin A1c
Time frame: 5 weeks
Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8)
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).
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Time frame: 5 weeks
Anxiety severity as measured by the Generalized Anxiety Disorder-7 scale (GAD-7)
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).
Time frame: 5 weeks
Suicidality as measured by the C-SSRS (Columbia-Suicide Severity Rating Scale)
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.
Time frame: 5 weeks