Indexing hint: Observational study · 2025
Repurposing Semaglutide and Liraglutide for Alcohol Use Disorder.
Lähteenvuo et al. 2025JAMA psychiatrycited by 102
PMID 39535805PMC11561716DOI 10.1001/jamapsychiatry.2024.3599PUB-39535805
Trial · Interventional
CompletedPhase 2Registry dataUnited States
1 trial · 1 completed
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is an open-label pilot study to evaluate the feasibility and preliminary efficacy of using tirzepatide when prescribed for its United States (US) Food and Drug Administration (FDA)-approved weight-related indication in individuals with comorbid methamphetamine use disorder.
Experimental
Tirzepatide
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 32-week period in accordance with FDA-prescribing label guidelines.
Outcomes the sponsor listed as primary.
Effect of tirzepatide on self-reported use of methamphetamine
Time frame · 36 weeks
Self-reported use of methamphetamine will be assessed through Timeline Followback. The Timeline Followback procedure will be used to elicit the participant's self-reported use of illicit substances, including but not limited to stimulants, and polysubstance use starting at the Screening Visit and continuing throughout study participation. During the Screening Visit, this form will be used to assess illicit use of substances for the 30-day period prior to written consent. During the study, TLFB will be administered to document the participant's self-reported use of illicit substances, nicotine, and tobacco for each visit since the previous TLFB assessment. Participant's drug of choice will be asked and determined by study coordinator and recorded along with the TLFB assessment.
Feasibility of using tirzepatide in individuals with Methamphetamine Use Disorder
Time frame · 4 weeks
Feasibility will be defined as the number of participants who receive a dose of tirzepatide of at least a 5mg/week for at least four weeks.
Changes in body mass index from baseline to the end of the 32-week treatment phase
Time frame · 32 weeks
Body mass index will be calculated using measurements of height and weight.
Changes in self-reported symptoms of anhedonia from baseline to the end of the 32-week treatment phase
Time frame · 32 weeks
Anhedonia, the inability to experience pleasure, will be assessed by the Snaith-Hamilton Pleasure Scale (SHAPS). The SHAPS questionnaire contains 14 items related to experiencing pleasure over the last several days. Participants are asked to rate their level of agreement or disagreement with each prompt. The scale has a scoring range of 0-14 where a higher point value indicates a higher level of anhedonia.
Changes in High-sensitivity C-reative protein (hs-CRP) levels from baseline to the end of the 32-week treatment phase
Time frame · 32 weeks
Clinical laboratory assessments for High-Sensitivity C-Reactive Protein (HsCRP) test will be performed to help determine eligibility at screening and monitor participant's overall health condition.
Changes in gastrointestinal symptom severity from baseline until the end of the 32-week treatment phase
Time frame · 32 weeks
Gastrointestinal symptom severity will be assessed by the Gastrointestinal Symptom Rating Scale (GSRS): a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The GSRS scale is graded on a seven-point Likert-type scale where a lower score (1) represents less symptom severity and highest score (7) represents greater symptom severity.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Observational study · 2025
Lähteenvuo et al. 2025JAMA psychiatrycited by 102
PMID 39535805PMC11561716DOI 10.1001/jamapsychiatry.2024.3599PUB-39535805
Indexing hint: Meta-analysis (pooled) · 2023
Tan et al. 2023International journal of obesity (2005)cited by 58
PMID 37253796DOI 10.1038/s41366-023-01321-5PUB-37253796
Who could join, as posted.
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