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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05860959




Registration number
NCT05860959
Ethics application status
Date submitted
5/05/2023
Date registered
16/05/2023
Date last updated
29/10/2024

Titles & IDs
Public title
SUBLOCADE Long-term Outcomes
Scientific title
A Phase IV Longitudinal Study of SUBLOCADE (SUBUTEX Prolonged Release) Clinical Outcomes in Adults with Opioid Use Disorder (Opioid Dependence)
Secondary ID [1] 0 0
INDV-6000-406
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid Use Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants achieving DSM-5 remission, early or sustained, (yes/no) while on initial SUBLOCADE treatment by 6 months and 1, 1.5, 2, 2.5, and 3 years from study Baseline
Timepoint [1] 0 0
up to a maximum of 4 years
Secondary outcome [1] 0 0
Key Secondary: Participants with "no symptoms" or improving by =1 DSM-5 severity classification within the last 3 months (moderate to mild, or severe to mild or moderate) relative to study Baseline (yes/no) at Month 6 and Years 1, 2, and 3
Timepoint [1] 0 0
up to a maximum of 4 years
Secondary outcome [2] 0 0
Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment
Timepoint [2] 0 0
up to a maximum of 4 years
Secondary outcome [3] 0 0
Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment
Timepoint [3] 0 0
up to a maximum of 4 years
Secondary outcome [4] 0 0
Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment
Timepoint [4] 0 0
up to a maximum of 4 years
Secondary outcome [5] 0 0
Time to discontinuing initial SUBLOCADE treatment and the corresponding reasons for discontinuation, eg, resolution of OUD symptoms, safety concerns, treatment failure, or seeking alternative MOUD treatment
Timepoint [5] 0 0
up to a maximum of 4 years
Secondary outcome [6] 0 0
Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment
Timepoint [6] 0 0
up to a maximum of 4 years
Secondary outcome [7] 0 0
The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms
Timepoint [7] 0 0
up to a maximum of 4 years
Secondary outcome [8] 0 0
Participants with any positive opioid use in the past month (yes/no) at Month 6 and Years 1, 2, and 3 while on initial SUBLOCADE treatment
Timepoint [8] 0 0
up to a maximum of 4 years
Secondary outcome [9] 0 0
Participants with opioid overdose requiring intervention (yes/no) while on initial SUBLOCADE treatment at least once during the first 6 months, and during Years 1, 2, and 3
Timepoint [9] 0 0
up to a maximum of 4 years

Eligibility
Key inclusion criteria
Participants must meet all of the following criteria:

* Is an adult = 18 years of age who has signed the informed consent form
* Plans to receive additional SUBLOCADE injections and

* Has initiated treatment for OUD/opioid dependence with SUBLOCADE within the last 3 months prior to Baseline Visit

* OR
* Has completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405) and has received the last dose of SUBLOCADE on that study within 3 months prior to Baseline Visit
* Is not currently participating in any clinical trial requiring medical intervention
* Is not currently using opioids to treat a diagnosis other than OUD/opioid dependence
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2027
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Newcastle Community Health Centre - Newcastle
Recruitment hospital [2] 0 0
Drug and Alcohol Services South Australia (DASSA) - Stepney
Recruitment hospital [3] 0 0
Hunter New England Local Health District - Newcastle
Recruitment hospital [4] 0 0
Eastern Health - Richmond
Recruitment postcode(s) [1] 0 0
2300 - Newcastle
Recruitment postcode(s) [2] 0 0
5069 - Stepney
Recruitment postcode(s) [3] 0 0
NSW 2302 - Newcastle
Recruitment postcode(s) [4] 0 0
VIC 3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maine
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Sweden
State/province [20] 0 0
Linköping
Country [21] 0 0
Sweden
State/province [21] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Indivior Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the recovery process. Long-term patterns of abstinence/opioid misuse as well as measures of participants' physical, psychological, social, and economic well-being will be monitored to better understand factors associated with recovery from opioid use disorder (OUD). Therefore, this study will observe participants up to a maximum of 4 years.
Trial website
https://clinicaltrials.gov/study/NCT05860959
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Global Director Clinical Development
Address 0 0
Country 0 0
Phone 0 0
(804) 594-4488
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05860959