- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06548490
GLP-1R Agonist Treatment for Opioid Use Disorder
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jennifer Nyland, PhD
- Phone Number: 717-531-6172
- Email: jnyland@pennstatehealth.psu.edu
Study Contact Backup
- Name: Kirsten Shuler, MSc
- Phone Number: 717-531-4104
- Email: kshuler@pennstatehealth.psu.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21223
- Recruiting
- University of Maryland Baltimore
-
Principal Investigator:
- Eric Weintraub, MD
-
Contact:
- Eric Weintraub
- Email: eweintra@som.umaryland.edu
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
-
Principal Investigator:
- Mathew Kladney, MD
-
Contact:
- Mat Kladney
- Phone Number: 929 573 0673
- Email: mathew.kladney@nyulangone.org
-
-
Pennsylvania
-
Harrisburg, Pennsylvania, United States, 17110
- Recruiting
- Pennsylvania Psychiatric Institute
-
Principal Investigator:
- Sarah Kawasaki, MD
-
Contact:
- Subi Upadhyay
- Email: supadhyay1@pennstatehealth.psu.edu
-
Contact:
- Angela Spangler
- Phone Number: (717) 683-7838
- Email: aspangler@pennstatehealth.psu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Semaglutide will be provided using an injection pen
Other Names:
|
|
Placebo Comparator: Control group
Participants in the control group will have placebo administered once per week.
|
Placebo will be a dry needle stick; no substances will be injected
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 2
|
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.
|
Study week 2
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 3
|
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.
|
Study week 3
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 4
|
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.
|
Study week 4
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 5
|
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.
|
Study week 5
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 6
|
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.
|
Study week 6
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 7
|
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.
|
Study week 7
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 8
|
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.
|
Study week 8
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 9
|
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.
|
Study week 9
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 10
|
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.
|
Study week 10
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 11
|
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.
|
Study week 11
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 12
|
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.
|
Study week 12
|
|
Number of participants being abstinent from illicit and nonprescribed opioids.
Time Frame: Study week 13
|
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.
|
Study week 13
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported opioid craving scores as assessed via smartphone surveys
Time Frame: Study week 1
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 1
|
|
Self-reported opioid craving scores as assessed via smartphone surveys
Time Frame: Study week 2
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 2
|
|
Self-reported opioid craving scores as assessed via smartphone surveys
Time Frame: Study week 5
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 5
|
|
Self-reported opioid craving scores as assessed via smartphone surveys
Time Frame: Study week 9
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 9
|
|
Self-reported opioid craving scores as assessed via smartphone surveys
Time Frame: Study week 13
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 13
|
|
Self-reported opioid craving scores as assessed via smartphone surveys
Time Frame: Study week 14
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 14
|
|
Self-reported opioid craving scores as assessed via smartphone surveys
Time Frame: Study week 18
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 18
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 2
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 2
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 3
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 3
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 4
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 4
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 5
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 5
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 6
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 6
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 7
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 7
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 8
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 8
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 9
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 9
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 10
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 10
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 11
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 11
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 12
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 12
|
|
Self-reported opioid craving as assessed via In-person Cravings Scales scores
Time Frame: Study week 13
|
Validated 0-4 scale measuring desire/intention to use drug where 0 is no desire/intention and 4 is the highest desire/intention
|
Study week 13
|
|
Number of subjects who sustained abstinence from opioids (Binary indicator)
Time Frame: Study week 10
|
Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.
|
Study week 10
|
|
Number of subjects who sustained abstinence from opioids (Binary indicator)
Time Frame: Study week 11
|
Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.
|
Study week 11
|
|
Number of subjects who sustained abstinence from opioids (Binary indicator)
Time Frame: Study week 12
|
Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.
|
Study week 12
|
|
Number of subjects who sustained abstinence from opioids (Binary indicator)
Time Frame: Study week 13
|
Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.
|
Study week 13
|
|
Number of subjects abstinent from stimulants (i.e. cocaine or non-prescribed amphetamines) (Binary indicator)
Time Frame: Study week 10
|
Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.
|
Study week 10
|
|
Number of subjects abstinent from stimulants (i.e. cocaine or non-prescribed amphetamines) (Binary indicator)
Time Frame: Study week 11
|
Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.
|
Study week 11
|
|
Number of subjects abstinent from stimulants (i.e. cocaine or non-prescribed amphetamines) (Binary indicator)
Time Frame: Study week 12
|
Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.
|
Study week 12
|
|
Number of subjects abstinent from stimulants (i.e. cocaine or non-prescribed amphetamines) (Binary indicator)
Time Frame: Study week 13
|
Weekly abstinence rating (see primary outcome above) is rated as abstinent over the last 4 weeks for the treatment period.
|
Study week 13
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 2
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 2
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 3
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 3
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 4
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 4
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 5
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 5
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 6
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 6
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 7
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 7
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 8
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 8
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 9
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 9
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 10
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 10
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 11
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 11
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 12
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 12
|
|
Days using stimulants over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 13
|
Validated daily binary indicator for measuring use of stimulants
|
Study week 13
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 2
|
Validated daily binary indicator for measuring use of opioids
|
Study week 2
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 3
|
Validated daily binary indicator for measuring use of opioids
|
Study week 3
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 4
|
Validated daily binary indicator for measuring use of opioids
|
Study week 4
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 5
|
Validated daily binary indicator for measuring use of opioids
|
Study week 5
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 6
|
Validated daily binary indicator for measuring use of opioids
|
Study week 6
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 7
|
Validated daily binary indicator for measuring use of opioids
|
Study week 7
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 8
|
Validated daily binary indicator for measuring use of opioids
|
Study week 8
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 9
|
Validated daily binary indicator for measuring use of opioids
|
Study week 9
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 10
|
Validated daily binary indicator for measuring use of opioids
|
Study week 10
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 11
|
Validated daily binary indicator for measuring use of opioids
|
Study week 11
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 12
|
Validated daily binary indicator for measuring use of opioids
|
Study week 12
|
|
Days using opioids over the 12-week treatment period by Timeline Followback questionnaire
Time Frame: Study week 13
|
Validated daily binary indicator for measuring use of opioids
|
Study week 13
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Nyland, PhD, Milton S. Hershey Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00024676
- UH3DA050325 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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VA Office of Research and DevelopmentActive, not recruiting
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National Institute on Drug Abuse (NIDA)CompletedSubstance-related Disorders
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Norwegian University of Science and TechnologyCompletedSubstance-related DisordersNorway
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University Hospital, Basel, SwitzerlandPsychiatric Hospital of the University of BaselCompleted
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University of LuebeckFederal Ministry of Health, GermanyCompletedSubstance-related Disorders
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University of Illinois at Urbana-ChampaignCompletedSubstance-related Disorders
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University of NebraskaCompletedSubstance-related Disorders | Alcohol-related DisordersUnited States
Clinical Trials on Semaglutide Pen Injector
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Novo Nordisk A/SCompletedObesity | OverweightGermany
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Prof. Dr. Martin WabitschNovo Nordisk A/SRecruitingMonogenic ObesityFrance, Germany, Netherlands, Spain, United Kingdom
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Novo Nordisk A/SCompleted
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Woman'sNovo Nordisk A/SRecruitingPre Diabetes | Postpartum DisorderUnited States
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Canadian Medical and Surgical Knowledge Translation...Unity Health Toronto; Western University, CanadaRecruitingCardiovascular Diseases | Obesity | Diabetes Mellitus, Type 2 | AtherosclerosisCanada
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Qilu Pharmaceutical Co., Ltd.Not yet recruiting
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Aga Khan UniversityRehman Medical Institute - RMIRecruitingDiabetes Mellitus, Type 2 | Weight Change, BodyPakistan
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University of NottinghamMedical Research CouncilRecruitingType 2 Diabetes Mellitus in ObeseUnited Kingdom
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Geisinger ClinicTerminatedObesity | Diabetic Kidney Disease | Type 2 Diabetes Mellitus in Obese | CKD | Severe ObesityUnited States
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Carmot Therapeutics, Inc.CompletedOverweight | Type 1 Diabetes Mellitus | ObeseUnited States