Clinical trial NCT05878210: Evaluating the SUBLOCADE Treatment Exit Strategy
Official title: A Phase IV Study to Evaluate the SUBLOCADE Treatment Exit Strategy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use Disorder
Keywords: Medicine for Opioid Use Disorder (MOUD)
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and discontinue SUBLOCADE treatment.

Brief summary: The purpose of this study is to observe and assess the successful taper and opioid withdrawal experience after participants stop receiving SUBLOCADE because their healthcare provider determines their disease symptoms have been controlled for at least 9 months and they, together with their healthcare provider, plan to discontinue MOUD.

Detailed description: This is a Phase IV, observational, multicentre, open-label, study in participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have had disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and both healthcare provider and participant plan to discontinue MOUD treatment.

Eligibility criteria: Inclusion Criteria

Participants must meet all of the following criteria:

* The participant, together with their healthcare provider (the investigator), have previously determined that it is appropriate to stop MOUD treatment, and the participant meets the following criteria:

  * Has been treated with at least 12 injections of SUBLOCADE.
  * In the opinion of the investigator, has had their OUD symptoms (ie, overdose, illicit/nonmedical use, withdrawal) controlled for at least 9 months.
  * In the opinion of the investigator, has had any other substance use disorder (excluding alcohol, nicotine, or cannabis) symptoms controlled for at least 9 months.
* Is willing to complete the Baseline Visit 4 to 8 weeks after the last dose of SUBLOCADE.
* Has signed the ICF and is 18 years of age or older.
* Is not currently using opioids to treat a diagnosis other than OUD.

Primary outcomes:
measure: Rate of successful taper by the end of 6-month follow-up.
timeFrame: 6 months
Secondary outcomes:
measure: Key secondary - At each given month, for participants not restarting MOUD and not consistently using illicit/nonmedical opioid up to the start of that month:
timeFrame: 6 months
measure: Participants restarting MOUD (yes/no) during study follow-up
timeFrame: 6 months
measure: Participants who reported withdrawal symptoms (yes/no) during the past month
timeFrame: 6 months
measure: Participants who used ancillary medications to treat opioid withdrawal symptoms (yes/no) during the past month
timeFrame: 6 months
measure: Participants who used rescue MOUD (yes/no) to treat opioid withdrawal symptoms during the past month
timeFrame: 6 months
measure: Participants who had self-reported illicit/nonmedical opioid use (yes/no) during the past month
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Comprehensive Addiction Medicine
state: Maine
city: Edmonton
country: Canada
facility: Savera Medical Centre
state: Alberta
Study officials:
affiliation: Indivior Inc.
name: (804) 594-4488
role: STUDY_DIRECTOR
References: