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GLP-1R Agonist

Semaglutide for Opioid Addiction

Phase 2

Waitlist Available

Led By Jennifer Nyland, PhD

Research Sponsored by Patricia Sue Grigson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 75 years

Be older than 18 years old

Must not have

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

End stage liver disease or previous liver transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study week 18

Summary

"This trial aims to see if semaglutide can help reduce illicit opioid use in adults undergoing treatment for opioid use disorder. Participants will either receive semaglutide or a placebo for 12 weeks

Who is the study for?

This trial is for adults in outpatient treatment for opioid use disorder who are currently on buprenorphine or methadone. Participants must be willing to take weekly injections, attend regular clinic visits for drug screening and health checks, and complete mental health assessments.

What is being tested?

The study tests if semaglutide can help people stop using illicit opioids compared to a placebo. It involves weekly injections of either the medication or placebo over 12 weeks, with regular monitoring through urine tests and questionnaires.

What are the potential side effects?

Semaglutide may cause digestive issues like nausea or constipation, headaches, fatigue, low blood sugar levels in diabetics, and possible allergic reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have type 2 diabetes or am currently using DPP-4 inhibitors.

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I have severe liver disease or have had a liver transplant.

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I have or had severe stomach or digestive problems.

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I haven't had serious heart or blood vessel problems in the last 6 months.

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I am not allergic or unable to take methadone, BUP, or GLP-1R agonist medications.

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I am younger than 18 or older than 75.

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I am not pregnant, planning to become pregnant, breastfeeding, and I am willing to use contraception.

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I am currently using GLP-1R agonist medication.

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I have type 1 diabetes or have had diabetic ketoacidosis.

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I have severe kidney issues, am on dialysis, have a GFR under 30, or had a kidney transplant.

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I have or had gallbladder disease or gallstones.

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I or my family have a history of thyroid cancer or I have MEN 2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study week 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study week 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and study week 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants being abstinent from illicit and nonprescribed opioids.

Secondary study objectives

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

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

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

+3 more

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220

26%

Nasopharyngitis

Constipation

Influenza

Diabetic retinopathy

Nausea

Gastrooesophageal reflux disease

Back pain

Upper respiratory tract inflammation

Abdominal discomfort

Vomiting

Diarrhoea

Cardiac ablation

Herpes zoster

Ischaemic cerebral infarction

Acute myocardial infarction

Appendicitis

Large intestine polyp

Peritonitis

Sudden hearing loss

Rectal adenocarcinoma

Spinal operation

100%

80%

60%

40%

20%

Study treatment Arm

Oral Semaglutide 3 mg

Oral Semaglutide 7 mg

Oral Semaglutide 14 mg

Dulaglutide 0.75 mg

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Investigational groupExperimental Treatment1 Intervention

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.

Group II: Control groupPlacebo Group1 Intervention

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

0 / 13Eligibility criteria met