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
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Semaglutide will be provided using an injection pen
Placebo will be a dry needle stick; no substances will be injected
University of Maryland Baltimore
Baltimore, Maryland, United States
COMPLETEDStanley Street Treatment and Resources
Fall River, Massachusetts, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGPennsylvania Psychiatric Institute
Harrisburg, Pennsylvania, United States
RECRUITINGNumber 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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