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Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence (BUP/NXT-VIVI)

Primary Purpose

Opiate Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
very low dose naltrexone
extended release naltrexone
buprenorphine/naloxone
Sponsored by
Paolo Mannelli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring Opioid Addiction, Addiction, Drug Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women 18 to 65 years of age who meet DSM-IV criteria for OD of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
  2. Individuals must be capable of giving informed consent and capable of complying with study procedures.
  3. Participants will be asked to provide locator information including the address and telephone number of a non-drug abusing relative or friend who can reach the participant in emergencies.

Exclusion Criteria:

  1. Individuals currently prescribed or regularly taking opiates for chronic pain or medical illness.
  2. Individuals regularly using licit or illicit methadone or BUP.
  3. Individuals meeting DSM-IV criteria for schizophrenia, schizoaffective or psychotic disorders, or psychiatric disorder (other than substance abuse) requiring intervention.
  4. Individuals who are medically unstable, or have liver enzyme function tests greater than two times normal.
  5. Individuals with current suicidal risk or 1 or more suicide attempts within the past year.
  6. History of accidental drug overdose in the last three years or any other significant history of overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation.
  7. Nursing/pregnant women, or failure in a sexually active man or woman to use adequate contraceptive methods (e.g., oral or depot contraceptives, foam, sponges, and/or condoms)
  8. Individuals who are dependent on any other drugs (excluding nicotine)
  9. Individuals with known sensitivity to BUP, VIVITROL, NTX, naloxone.
  10. Individuals who are court-mandated to treatment.
  11. Individuals who have a current or pending legal status, or any other condition that would make them unlikely to be available for the duration of the study.

Sites / Locations

  • Duke University Medical Center / Civitan Building

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BUP/VLNXT to VIVITROL

Arm Description

On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.

Outcomes

Primary Outcome Measures

Retention in Treatment
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks.

Secondary Outcome Measures

Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment. COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores ranged from 0-48, with 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.
Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment. SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). Total score range is 0 - 64; the higher the score the more withdrawal symptoms.
Craving
Craving, assessed with a 100-point Visual Analog Scale (VAS), ranging from 'not at all' (0) to 'more than ever' (100). The higher the score the higher the craving.
Illicit Drug Use, Measured by Urine Drug Testing
number of participants that tested positive for marijuana, cocaine, and opiates.
Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire
Questionnaire consisted of 3 questions. Were you satisfied with the treatment (range 1-5): Completely satisfied (1) to completely dissatisfied (5). Were you satisfied with withdrawal treatment (range 1-5): Minimal withdrawal (1) to worse than ever (5). Did the medication help (range 1-5): Helped a lot (1) to No it did not help (5). Lower scores represent greater satisfaction.
Percentage of Participants Who Adhered to Study Visits.
Percentage of Participants With Adherence to Medication (Naltrexone)
Participant who took Naltrexone as prescribed.
Use of Ancillary Medications.
Number of participants that took ancillary medication
Number of Participants That Self Reported Illicit Drug Use
Participants reported on any illicit drug use to include Cocaine marijuana opiates

Full Information

First Posted
September 19, 2012
Last Updated
April 25, 2016
Sponsor
Paolo Mannelli
Collaborators
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01690546
Brief Title
Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
Acronym
BUP/NXT-VIVI
Official Title
An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paolo Mannelli
Collaborators
Alkermes, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.
Detailed Description
Thirty-five opioid dependent (OD) volunteers seeking treatment will be enrolled in an open-label, flexible-dosing, outpatient trial at Duke Addictions Program. On days 1-3, participants will receive buprenorphine/naloxone daily at a starting dose of 4mg, progressively decreasing to 2 mg on days 2- 3. Participants will also receive very low dose naltrexone (VLNTX) at a dose of 0.25 mg to 1mg on Days 1-3, 2 to 6 mg on Day 4 and between 10 and 50 mg on Days 5-7. Then a VIVITROL injection, 380 mg, will be administered on Day 8. Evaluations will occur daily for up to 6 hours until 1 day after VIVITROL injection and then weekly for 4 weeks. Patients will receive ancillary medications as needed and weekly psychosocial intervention. At the end of the study, participants will be offered outpatient treatment of OD at the study site, or will be referred to other treatment programs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
Opioid Addiction, Addiction, Drug Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BUP/VLNXT to VIVITROL
Arm Type
Experimental
Arm Description
On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
Intervention Type
Drug
Intervention Name(s)
very low dose naltrexone
Intervention Description
On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
Intervention Type
Drug
Intervention Name(s)
extended release naltrexone
Other Intervention Name(s)
Vivitrol
Intervention Description
On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
Intervention Type
Drug
Intervention Name(s)
buprenorphine/naloxone
Other Intervention Name(s)
Suboxone
Intervention Description
On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
Primary Outcome Measure Information:
Title
Retention in Treatment
Description
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)
Description
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment. COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores ranged from 0-48, with 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.
Time Frame
4 weeks
Title
Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)
Description
After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment. SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). Total score range is 0 - 64; the higher the score the more withdrawal symptoms.
Time Frame
4 weeks
Title
Craving
Description
Craving, assessed with a 100-point Visual Analog Scale (VAS), ranging from 'not at all' (0) to 'more than ever' (100). The higher the score the higher the craving.
Time Frame
4 weeks
Title
Illicit Drug Use, Measured by Urine Drug Testing
Description
number of participants that tested positive for marijuana, cocaine, and opiates.
Time Frame
4 weeks
Title
Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire
Description
Questionnaire consisted of 3 questions. Were you satisfied with the treatment (range 1-5): Completely satisfied (1) to completely dissatisfied (5). Were you satisfied with withdrawal treatment (range 1-5): Minimal withdrawal (1) to worse than ever (5). Did the medication help (range 1-5): Helped a lot (1) to No it did not help (5). Lower scores represent greater satisfaction.
Time Frame
Day 9
Title
Percentage of Participants Who Adhered to Study Visits.
Time Frame
baseline to end of study (approximately 40 days)
Title
Percentage of Participants With Adherence to Medication (Naltrexone)
Description
Participant who took Naltrexone as prescribed.
Time Frame
Day 1 to Day 8 (+/- 2 days)
Title
Use of Ancillary Medications.
Description
Number of participants that took ancillary medication
Time Frame
baseline to week 1
Title
Number of Participants That Self Reported Illicit Drug Use
Description
Participants reported on any illicit drug use to include Cocaine marijuana opiates
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18 to 65 years of age who meet DSM-IV criteria for OD of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear. Individuals must be capable of giving informed consent and capable of complying with study procedures. Participants will be asked to provide locator information including the address and telephone number of a non-drug abusing relative or friend who can reach the participant in emergencies. Exclusion Criteria: Individuals currently prescribed or regularly taking opiates for chronic pain or medical illness. Individuals regularly using licit or illicit methadone or BUP. Individuals meeting DSM-IV criteria for schizophrenia, schizoaffective or psychotic disorders, or psychiatric disorder (other than substance abuse) requiring intervention. Individuals who are medically unstable, or have liver enzyme function tests greater than two times normal. Individuals with current suicidal risk or 1 or more suicide attempts within the past year. History of accidental drug overdose in the last three years or any other significant history of overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation. Nursing/pregnant women, or failure in a sexually active man or woman to use adequate contraceptive methods (e.g., oral or depot contraceptives, foam, sponges, and/or condoms) Individuals who are dependent on any other drugs (excluding nicotine) Individuals with known sensitivity to BUP, VIVITROL, NTX, naloxone. Individuals who are court-mandated to treatment. Individuals who have a current or pending legal status, or any other condition that would make them unlikely to be available for the duration of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Mannelli, MD
Organizational Affiliation
Duke University Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center / Civitan Building
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence

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