A Phase 2/3 interventional study of Buprenorphine and Naltrexone in Opioid-use Disorder, sponsored by New York State Psychiatric Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by New York State Psychiatric Institute · Phase 2/3, Interventional, and Treatment
The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX. There will be three different methods of XR-NTX induction using increasing doses of oral naltrexone and buprenophine.
Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.
Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.
Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.
All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 10 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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Exclusion Criteria:
Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.
Drug: Buprenorphine · Drug: Naltrexone · Drug: Vivitrol
Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.
Drug: Buprenorphine · Drug: Naltrexone · Drug: Vivitrol
Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.
Drug: Buprenorphine · Drug: Naltrexone · Drug: Vivitrol
Buprenorphine will be administered daily
On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX
Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Also known as: XR-NTX
Percentage of Patients Who Receive the Second Injection of XR-NTX.
Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX
Time frame: 4 weeks after 1st injection
| Milestone | Procedure 1 | Procedure 2 | Procedure 3 |
|---|---|---|---|
| Started | 10 | 0 | 0 |
| Completed | 5 | 0 | 0 |
| Not completed | 5 | 0 | 0 |
| Withdrew: Withdrawal by subject | 5 | 0 | 0 |
Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX
| Participants | Procedure 1 |
|---|---|
| Percentage of Patients Who Receive the Second Injection of XR-NTX. | 6 |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Procedure 1 | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Procedure 1 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Age, Continuous(years) | Procedure 1 |
|---|---|
| Mean | 34.5 (24 to 55) |
| Sex: Female, Male(Participants) | Procedure 1 |
|---|---|
| Female | 3 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Procedure 1 |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Procedure 1 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 3 |
| More than one race | 2 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Procedure 1 |
|---|---|
| United States | 10 |
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New York State Psychiatric Institute