GLP-1R Agonist Treatment for Opioid Use Disorder
NCT Number: NCT06548490
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Opioid Use Disorder|Opioid Abuse and Addiction|Narcotic-Related Disorders|Substance-Related Disorders|Chemically-Induced Disorders|Mental Disorder|Opioid
Interventions: DRUG: Semaglutide Pen Injector|DRUG: Placebo
Sponsor: Patricia Sue Grigson
Collaborators: New York University|University of Maryland|National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-11
Locations: Pennsylvania Psychiatric Institute, Harrisburg, Pennsylvania, 17110, United States

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

Primary Outcome Measures: 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), 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), Study week 13
Secondary Outcome Measures: 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, 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, 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, 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, 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, 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, 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, Study week 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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., 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., 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., 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., 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., 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., 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., 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., 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, Study week 13