Status:
COMPLETED
Evaluation of Long-term Buprenorphine Plasma Exposure
Lead Sponsor:
Indivior Inc.
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
Brief Summary
The study objective is to characterise the long-term plasma exposure to buprenorphine after stopping SUBLOCADE treatment. There are no interventions planned. This multicentre investigation will enrol...
Detailed Description
Data indicate that after discontinuing SUBLOCADE patients may have detectable concentrations of buprenorphine in plasma and urine for 12 months or longer. Previous Phase II/III studies did not evaluat...
Eligibility Criteria
Inclusion
- Participated in Study RB-US-13-0003 or both Studies RB-US-13-0003 and INDV-6000-301 and received at least 2 subcutaneous (SC) injections of SUBLOCADE
- Within 12 to 36 months post his or her last SUBLOCADE injection at the time of the Screening Visit
- Female individuals of childbearing potential must agree to have a pregnancy test administered prior to enrollment and throughout the study. Pregnancy does not prohibit participation
- Willing to adhere to study procedures and provide written informed consent prior to the start of any study procedures.
Exclusion
- Received SUBLOCADE or any other long-acting buprenorphine product at any time after ending their participation in Study RB-US-13-0003 or Study INDV-6000-301
- Taken any buprenorphine (prescribed or illicit) within 3 weeks prior to the Screening visit (study Part A, Visit 1)
Key Trial Info
Start Date :
February 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 18 2019
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03752528
Start Date
February 19 2019
End Date
July 18 2019
Last Update
August 21 2020
Active Locations (11)
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1
Pathway Healthcare
Hamilton, Alabama, United States, 35570
2
Meridian Research
Tampa, Florida, United States, 33606
3
Phoenix Medical Research
Prairie Village, Kansas, United States, 66208
4
Adams Clinical
Watertown, Massachusetts, United States, 02472