Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-02 @ 2:16 PM
Study NCT ID:
NCT01882361
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2013-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment. Participants will be randomized under double blind conditions to a 24 or 48-week course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in weeks 24 to 48.
Detailed Description:
1.2.1 Primary and Secondary Outcome Measures
Primary outcomes are:
1\) Opiate positive urine tests; 2) HIV injecting risk.
Secondary outcomes are:
1\) Time to relapse; 2) HIV sex risk; 3) Proportion of appointments kept; 6) Psychiatric symptoms; 7) Opioid craving; 8) Self-reported drug use; 9) Money spent for drugs; 10) Employment; 11) Arrests; 12) Overall adjustment; 12) Adverse events.
Hypotheses are that:
1. Primary outcomes will significantly favor the 48-week Vivitrol condition;
2. Five or more secondary outcomes will favor the 48-week condition; none will favor the 24-week condition.
Primary outcomes are:
1\) Opiate positive urine tests; 2) HIV injecting risk.
Secondary outcomes are:
1\) Time to relapse; 2) HIV sex risk; 3) Proportion of appointments kept; 6) Psychiatric symptoms; 7) Opioid craving; 8) Self-reported drug use; 9) Money spent for drugs; 10) Employment; 11) Arrests; 12) Overall adjustment; 12) Adverse events.
Hypotheses are that:
1. Primary outcomes will significantly favor the 48-week Vivitrol condition;
2. Five or more secondary outcomes will favor the 48-week condition; none will favor the 24-week condition.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA033670 | NIH | None | https://reporter.nih.gov/quic… | View |