ClinicalTrials.gg
Sign In
RecruitingNCT06548490Updated Aug 28, 2026

GLP-1R Agonist Treatment for Opioid Use Disorder

A Phase 2 interventional study of Semaglutide Pen Injector and Placebo in Opioid Use Disorder, Opioid Abuse and Addiction and Narcotic-Related Disorders, sponsored by Milton S. Hershey Medical Center. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Milton S. Hershey Medical Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is:

  • Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids?

The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids.

The participants will:

  • Take semaglutide or a placebo every week for 12 weeks
  • Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires
  • Complete smartphone surveys sent at set times during the study
Read the detailed description

The purpose of this study is to determine whether 12 weeks of once-weekly treatment with the glucagon-like peptide-1 receptor (GLP-1R) agonist, semaglutide, will reduce illicit opioid use over a 19 week period (129-172 days) among individuals in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment (i.e., medication for opioid use disorder; MOUD). Following successful consent and initiation of screening, participants will complete a baseline evaluation and begin a baseline data collection period. If screened into the study, they will be randomly assigned to semaglutide or placebo control arms, in a 1:1 ratio using a permuted-block randomization algorithm stratified by site and MOUD, and begin a 1-week baseline period. Semaglutide (injector pen) or placebo will be administered as a subcutaneously (SC) once per week for 12 weeks, starting at a dose of 0.25 mg SC and advanced on a fixed-flexible dose schedule, based on tolerability, to a dose of 1.0 mg SC per week, or the maximum tolerated dose if less than 1.0 mg. Participants will receive study intervention in an outpatient setting for a total of 12 weeks. After the 12-week intervention, participants will discontinue semaglutide or placebo and be observed for an additional week (wash-out period). A final follow-up visit will then take place approximately 4 weeks after the washout visit (calculated as 18 weeks after Baseline/Treatment Visit 1).

During each study visit, participants will undergo urine drug screening and pregnancy testing, vital signs collection, and complete mental health and drug use questionnaires. Participants will also complete smartphone surveys sent at set times during the study. Blood samples will be collected at 2 of the visits (screening and the study week 14) and a physical examination and medical history collection will be done at the baseline visit.

02

Conditions studied

  • Opioid Use Disorder
  • Opioid Abuse and Addiction
  • Narcotic-Related Disorders
  • Substance-Related Disorders
  • Chemically-Induced Disorders
  • Mental Disorder
  • Opioid

Keywords

  • Opiate treatment
  • Opioid treatment
  • Glucagon-Like Peptide-1 Agonist
  • Opioid use disorder
  • Semaglutide
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 200 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.

Browse Milton S. Hershey Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 to 75 years.
  • (BMI) > 18.
  • Able and willing to provide 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 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 or or to abstain from sexual activity that could result in pregnancy (if applicable) 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

Exclusion Criteria:

  • Age \< 18 or > 75 years.
  • \<18.
  • Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate measures.
  • Current use of glucagon-like peptide 1 receptor (GLP-1R) agonist.
  • History of angioedema, serious 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 (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 drug in the one month preceding the study.
  • Any 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Investigational group

    Participants randomized to semaglutide will be started at a low dose (0.25 mg once per week) which will be gradually increased weekly until 1.0 mg is reached at Week 4 of the intervention.

    Drug: Semaglutide Pen Injector

  • Placebo comparator
    Control group

    Participants in the control group will have placebo administered once per week.

    Drug: Placebo

Interventions

  • DrugSemaglutide Pen Injector

    Semaglutide will be provided using an injection pen

    Also known as: Ozempic

  • DrugPlacebo

    Placebo will be a dry needle stick; no substances will be injected

    Also known as: Dry needle stick

06

What researchers measure

Primary outcomes

  1. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 2

  2. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 3

  3. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 4

  4. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 5

  5. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 6

  6. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 7

  7. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 8

  8. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 9

  9. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 10

  10. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 11

  11. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 12

  12. Number of participants being abstinent from illicit and nonprescribed opioids.

    Each week in the 12 week trial period will be rated as abstinent if both urine test and participants' report by Timeline FollowBack (TLFB) questionnaire are negative for illicit/non-prescribed opioids, or urine is negative and TLFB missing, or TLFB negative and urine missing; and not abstinent otherwise (either urine positive, or TLFB positive, or both are missing). For certain opioids (e.g., fentanyl), declining rates in urine will be considered negative for usage.

    Time frame: Study week 13

Secondary outcomes

  1. Self-reported opioid craving scores as assessed via smartphone surveys

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 1

  2. Self-reported opioid craving scores as assessed via smartphone surveys

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 2

  3. Self-reported opioid craving scores as assessed via smartphone surveys

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 5

  4. Self-reported opioid craving scores as assessed via smartphone surveys

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 9

  5. Self-reported opioid craving scores as assessed via smartphone surveys

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 13

  6. Self-reported opioid craving scores as assessed via smartphone surveys

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 14

  7. Self-reported opioid craving scores as assessed via smartphone surveys

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 18

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 2

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 3

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 4

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 5

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 6

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 7

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 8

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 9

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 10

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 11

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 12

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

    Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention

    Time frame: Study week 13

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

    Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.

    Time frame: Study week 10

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

    Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.

    Time frame: Study week 11

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

    Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.

    Time frame: Study week 12

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

    Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.

    Time frame: Study week 13

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

    Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.

    Time frame: Study week 10

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

    Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.

    Time frame: Study week 11

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

    Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.

    Time frame: Study week 12

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

    Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.

    Time frame: Study week 13

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 2

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 3

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 4

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 5

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 6

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 7

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 8

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 9

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 10

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 11

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 12

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

    Validated daily binary indicator for measuring use of stimulants

    Time frame: Study week 13

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 2

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 3

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 4

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 5

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 6

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 7

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 8

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 9

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 10

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 11

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 12

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

    Validated daily binary indicator for measuring use of opioids

    Time frame: Study week 13

07

Study locations

3 of 4 sites recruiting
08

References and documents

Publications

  • Freet CS, Shuler K, Kawasaki S, Weintraub E, Greenblatt A, Kladney M, Nunes E, Foster KL, Kong L, Raja-Khan N, Cleveland HH, Grigson PS, Bunce SC, Brick TR, Nyland JE. 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. Addict Sci Clin Pract. 2025 Oct 30;20(1):89. doi: 10.1186/s13722-025-00618-2. PubMed 41168808 ↗
  • Freet CS, Shuler K, Kawasaki S, Weintraub E, Greenblatt A, Kladney M, Nunes E, Foster KL, Kong L, Raja-Khan N, Cleveland HH, Grigson PS, Bunce SC, Brick TR, Nyland JE. 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. Res Sq [Preprint]. 2025 May 26:rs.3.rs-6666196. doi: 10.21203/rs.3.rs-6666196/v1. PubMed 40502777 ↗

Individual participant data

Plan to share: No — Only summary data will be made available. No individual participant data (IPD) will be shared with other researchers.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Apr 2027, 27 months after the start.

Of 61 non-industry phase 2 interventional studies under Opioid-Related Disorders, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 27 months is below that.

Counting every sponsor, half of 68 studies reached it within 40 months; a quarter within 23 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2024
First posted
Aug 12, 2024
StartActual
Jan 27, 2025
Primary completionEst.
Apr 30, 2027
CompletionEst.
Apr 30, 2027
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06548490
Lead sponsor
Milton S. Hershey Medical Center
Collaborators
New York University, University of Maryland, National Institute on Drug Abuse (NIDA), Stanley Street Treatment and Resources (SSTAR)
Responsible party
Patricia Sue Grigson (Chairperson (Academic Administrator) Neural and Behavioral Sciences, Milton S. Hershey Medical Center) — Principal investigator
First posted
Aug 12, 2024
Start date
Jan 27, 2025
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Aug 28, 2026

Study contacts

Jennifer Nyland, PhD
Contact
jnyland@pennstatehealth.psu.edu
717-531-6172
Kirsten Shuler, MSc
Contact
kshuler@pennstatehealth.psu.edu
717-531-4104
Jennifer Nyland, PhD
principal investigator · Milton S. Hershey Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Semaglutide

Other studies in this condition

Opioid-Related Disorders →

Other studies from this sponsor

Milton S. Hershey Medical Center →

Start the discussion