GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT06548490

RecruitingPhase 2

GLP-1R Agonist Treatment for Opioid Use Disorder

Lead sponsor

Milton S. Hershey Medical Center

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

200

estimated

Study population

Alcohol / substance use

Key I/E criterion

•BMI ≥18

Primary endpoints

•Number of participants being abstinent from illicit and nonprescribed opioids•AUDIT score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06548490

Org study IDSTUDY00024676

Secondary IDUH3DA050325

Timeline

Milestones

Study first posted2024-08-12actual

Study start2025-01-13actual

Last update posted2025-08-14actual

Primary completion2026-11estimated (month precision)

Study completion2026-11estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 18 to 75 years.

•Body mass index (BMI) > 18.

•Able and willing to provide informed consent prior to any study-related activities.

•Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International Neuropsychiatric Interview (MINI) or per the site clinic diagnosis. Patients are eligible if they have a MINI > 3 ("moderate" or "severe" in the "Specify If" box in the Substance Use Disorder (Non-Alcohol) module for the category of opiates).

•Currently receiving outpatient treatment for OUD and at least 2 weeks on buprenorphine (BUP) or 4 weeks on methadone at the study site and/or at an associated clinic at the time of enrollment.

•Have at least 1 urine test positive for opioids after 2 weeks on BUP or 4 weeks on methadone.

•Have positive self-reporting of opioid use after 2 weeks on BUP or 4 weeks on methadone.

•If anatomically capable of becoming pregnant and of childbearing age, is not pregnant (confirmed) or breastfeeding at the time of enrollment and agrees to use a medically accepted method of birth control or to abstain from sexual intercourse while in the study.

•Able to read and communicate in English to the level required to accept standard care and complete all study requirements.

•Able and willing to engage/adhere to the entirety of the study protocol (19 weeks).

•Not currently a prisoner.

Exclusion criteria

•Age < 18 or > 75 years.

•BMI <18.

•Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.

•Current use of glucagon-like peptide 1 receptor (GLP-1R) agonist.

•History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to semaglutide or another GLP-1R agonist.

•Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome Type 2 (MEN 2) or thyroid nodule.

•Type 1 diabetes or history of diabetic ketoacidosis.

•Type 2 diabetes mellitus or current use of a dipeptidyl peptidase-4 (DPP-4) inhibitor.

•Past 30-day use of Sincalide, Sulfonylureas, insulin and insulin products or other medications that may interact with semaglutide.

•Hypoglycemia on intake visit (blood glucose < 60 mg/dL).

•End-stage renal failure, on dialysis, or glomerular filtration rate (GFR) <30 mL/min per 1.73 square meters or previous renal transplant.

•End stage liver disease or previous liver transplant.

•Current or past diagnosis of pancreatitis, gastroparesis, or other severe gastrointestinal (GI) disease.

•Current or past diagnosis of gallbladder disease or gallstones.

•Serious cardiovascular disease within the past 6 months (e.g. uncontrolled hypertension, heart failure, significant cardiac arrhythmias, myocardial infarction, presence of angina pectoris, symptomatic coronary artery disease, deep vein thrombosis, pulmonary embolism, second- or third-degree heart block, mitral valve or aortic stenosis, hypertrophic cardiomyopathy, stroke).

•Severe co-occurring psychiatric disorder (e.g., bipolar disorder, psychotic disorder, schizophrenia), and/or history or evidence of organic brain disease or dementia that would compromise safety or compliance with the study protocol in the opinion of the site principal investigator (PI) and/or physician. As there is no specific scale that determines this, this will include the Site PI/physician determining if the potential participant shows consistency in decision making and if they are alert and oriented to time, date, day and location.

•Significant risk of suicide requiring a different/higher level of care, according to the clinical judgment of the study physician or site principal investigator, or history of suicide attempts within the past 1 year, unless participation is cleared by clinician assessment and/or judgment. A Columbia-Suicide Severity Rating Scale (C-SSRS) indicating a history of suicide attempts within the past year, or active suicidal ideation within the past 1 month, will qualify as significant risk of suicide.

•Treatment with any investigational drug in the one month preceding the study.

•Any contraindication to both methadone and BUP.

•Any contraindication to a GLP-1R agonist.

•Previous randomization for participation in this trial.

•Any other condition at screening that precludes safe participation in the trial in the judgment of the site PI or study physician.

•Plans for travel outside of the local area over the 19 weeks (1 week of baseline, 12 weeks of medication, 1 week wash-out, and follow-up after a further 28 days) that would interfere with visits during the study period or other logistic factors that would make it difficult to commit to the entire duration of study.

•Currently a prisoner.

Endpoints (63)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Patient-reported / QoL

9 endpoints

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 2

descriptive, improvement

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 3

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 4

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 5

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 6

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 9

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 10

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 11

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 12

change from baseline, improvement

Other clinical outcomes

54 endpoints

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 2

threshold achievement, improvement

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 3

threshold achievement, improvement

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 4

threshold achievement, improvement

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 5

categorical status, improvement

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 6

categorical status, improvement

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 7

threshold achievement, improvement

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 8

threshold achievement, improvement

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 9

threshold achievement, improvement

Primary/protocol endpoint/low confidence

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 10

AUDIT score

threshold achievement, improvement

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 11

threshold achievement, improvement

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 12

categorical status, improvement

Primary/protocol endpoint

Number of participants being abstinent from illicit and nonprescribed opioids.

Time frame:Study week 13

threshold achievement, improvement

Secondary/protocol endpoint

Self-reported opioid craving scores as assessed via smartphone surveys

Time frame:Study week 1

descriptive, improvement

Secondary/protocol endpoint

Self-reported opioid craving scores as assessed via smartphone surveys

Time frame:Study week 2

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving scores as assessed via smartphone surveys

Time frame:Study week 5

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving scores as assessed via smartphone surveys

Time frame:Study week 9

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving scores as assessed via smartphone surveys

Time frame:Study week 13

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving scores as assessed via smartphone surveys

Time frame:Study week 14

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving scores as assessed via smartphone surveys

Time frame:Study week 18

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 7

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 8

AUDIT score

change from baseline, improvement

Secondary/protocol endpoint

Self-reported opioid craving as assessed via In-person Cravings Scales scores

Time frame:Study week 13

change from baseline, improvement

Secondary/protocol endpoint

Number of subjects who sustained abstinence from opioids (Binary indicator)

Time frame:Study week 10

categorical status, improvement

Secondary/protocol endpoint

Number of subjects who sustained abstinence from opioids (Binary indicator)

Time frame:Study week 11

categorical status, improvement

Secondary/protocol endpoint

Number of subjects who sustained abstinence from opioids (Binary indicator)

Time frame:Study week 12

categorical status, improvement

Secondary/protocol endpoint

Number of subjects who sustained abstinence from opioids (Binary indicator)

Time frame:Study week 13

categorical status, improvement

Secondary/protocol endpoint

Number of subjects abstinent from stimulants (i.e. cocaine or non-prescribed amphetamines) (Binary indicator)

Time frame:Study week 10

categorical status, improvement

Secondary/protocol endpoint

Number of subjects abstinent from stimulants (i.e. cocaine or non-prescribed amphetamines) (Binary indicator)

Time frame:Study week 11

threshold achievement, improvement

Secondary/protocol endpoint

Number of subjects abstinent from stimulants (i.e. cocaine or non-prescribed amphetamines) (Binary indicator)

Time frame:Study week 12

threshold achievement, improvement

Secondary/protocol endpoint

Number of subjects abstinent from stimulants (i.e. cocaine or non-prescribed amphetamines) (Binary indicator)

Time frame:Study week 13

categorical status, improvement

Secondary/protocol endpoint/low confidence

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 2

AUDIT score

event count, improvement

Secondary/protocol endpoint

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 3

event count, improvement

Secondary/protocol endpoint

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 4

AUDIT score

event count, improvement

Secondary/protocol endpoint/low confidence

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 5

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint/low confidence

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 6

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 7

descriptive, improvement

Secondary/protocol endpoint

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 8

event count, improvement

Secondary/protocol endpoint

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 9

descriptive, improvement

Secondary/protocol endpoint/low confidence

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 10

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint/low confidence

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 11

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint/low confidence

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 12

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint/low confidence

Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 13

Alcohol consumption, change

descriptive, improvement

Secondary/protocol endpoint/low confidence

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 2

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 3

descriptive, improvement

Secondary/protocol endpoint/low confidence

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 4

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint/low confidence

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 5

opioid use days timeline followback

event count, improvement

Secondary/protocol endpoint/low confidence

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 6

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint/low confidence

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 7

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 8

event count, improvement

Secondary/protocol endpoint

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 9

descriptive, improvement

Secondary/protocol endpoint/low confidence

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 10

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint/low confidence

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 11

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint/low confidence

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 12

Alcohol consumption, change

event count, improvement

Secondary/protocol endpoint/low confidence

Days using opioids over the 12-week treatment period by Timeline Followback questionnaire

Time frame:Study week 13

Alcohol consumption, change

event count, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Efficacy of the GLP-1 receptor agonist, semaglutide, in abstinence from illicit and nonprescribed opioids in an outpatient population with OUD: a randomized, double-blind, placebo-controlled clinical trial protocol.
Addiction science & clinical practice2025 Oct 30PMID41168808doi:10.1186/s13722-025-00618-2via clinicaltrials gov reference derived + pubmed nct search
Efficacy of the GLP-1 receptor agonist, semaglutide, in abstinence from illicit and nonprescribed opioids in an outpatient population with treatment-refractory OUD: A randomized, double-blind, placebo-controlled clinical trial protocol.
Research square2025 May 26PMID40502777doi:10.21203/rs.3.rs-6666196/v1via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.