Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Procedure 1 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
Buprenorphine will be administered daily
Drug: Naltrexone
On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX
Drug: Vivitrol
Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Other Names:
|
| Experimental: Procedure 2 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
Buprenorphine will be administered daily
Drug: Naltrexone
On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX
Drug: Vivitrol
Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Other Names:
|
| Experimental: Procedure 3 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
Buprenorphine will be administered daily
Drug: Naltrexone
On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX
Drug: Vivitrol
Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Patients Who Receive the Second Injection of XR-NTX. [4 weeks after 1st injection]
Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-60.
-
Meets DSM-5 criteria for current opioid use disorder (moderate-severe) of at least six months duration, supported by urine toxicology OR COWS score > or =6 OR Naloxone Challenge.
-
Voluntarily seeking treatment for opioid dependence.
-
In otherwise good health based on complete medical history and physical examination within normal ranges (AST or ALT < 3 times normal). )
-
Able to give written informed consent.
Exclusion Criteria:
-
Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).
-
Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists.
-
Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
-
Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT > 3 times normal, AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection), unstable diabetes.
-
Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, or suicide risk or 1 or more suicide attempts within the past year.
-
Physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.
-
History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
-
Chronic organic mental disorder (e.g. AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection) dementia).
-
History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
-
Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York State Psychiatric Institute | New York | New York | United States | 10032 |
Sponsors and Collaborators
- New York State Psychiatric Institute
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- #7456
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Procedure 1 | Procedure 2 | Procedure 3 |
|---|---|---|---|
| Arm/Group Description | 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later. | 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later. | 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later. |
| Period Title: Overall Study | |||
| STARTED | 10 | 0 | 0 |
| COMPLETED | 5 | 0 | 0 |
| NOT COMPLETED | 5 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Procedure 1 |
|---|---|
| Arm/Group Description | 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later. |
| Overall Participants | 10 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
10
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
34.5
|
| Sex: Female, Male (Count of Participants) | |
| Female |
3
30%
|
| Male |
7
70%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
2
20%
|
| Not Hispanic or Latino |
8
80%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
3
30%
|
| White |
3
30%
|
| More than one race |
2
20%
|
| Unknown or Not Reported |
2
20%
|
| Region of Enrollment (participants) [Number] | |
| United States |
10
100%
|
Outcome Measures
| Title | Percentage of Patients Who Receive the Second Injection of XR-NTX. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| all participants enrolled in the study (Procedure 1) |
| Arm/Group Title | Procedure 1 |
|---|---|
| Arm/Group Description | 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later. |
| Measure Participants | 10 |
| Count of Participants [Participants] |
6
60%
|
Adverse Events
| Time Frame | 8 weeks | |
|---|---|---|
| Adverse Event Reporting Description | AE data were collected over the period of study participation, which is 8 weeks for each participant | |
| Arm/Group Title | Procedure 1 | |
| Arm/Group Description | 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later. | |
All Cause Mortality |
||
| Procedure 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Serious Adverse Events |
||
| Procedure 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Procedure 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Adam Bisaga MD |
|---|---|
| Organization | NYS Psychiatric Institute |
| Phone | 646-774-6155 |
| adam.bisaga@nyspi.columbia.edu |
- #7456