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

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ClinicalTrials.gov Identifier: NCT01690546
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Paolo Mannelli, Duke University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opiate Dependence
Interventions Drug: very low dose naltrexone
Drug: extended release naltrexone
Drug: buprenorphine/naloxone
Enrollment 38
Recruitment Details 38 participants signed consent. 3 participants were screen failures. 35 participants started study.
Pre-assignment Details  
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 35
Extended Release Injectable NTX 27
Completed 26
Not Completed 9
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants
40.1
(25 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
9
  25.7%
Male
26
  74.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 35 participants
African American 26
Caucasian 9
Years of Opioid use  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants
9.7
(7 to 18)
1.Primary Outcome
Title Retention in Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received the Extended Release Injectable NTX
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
26
2.Secondary Outcome
Title Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received the Extended Release Injectable NTX
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.64  (1.29)
3.Secondary Outcome
Title Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.52  (3.19)
4.Secondary Outcome
Title Craving
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.12  (14.41)
5.Secondary Outcome
Title Illicit Drug Use, Measured by Urine Drug Testing
Hide Description number of participants that tested positive for marijuana, cocaine, and opiates.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
Marijuana 11
Cocaine 3
Opiates 4
6.Secondary Outcome
Title Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire
Hide Description

Questionnaire consisted of 3 questions.

  1. Were you satisfied with the treatment (range 1-5): Completely satisfied (1) to completely dissatisfied (5).
  2. Were you satisfied with withdrawal treatment (range 1-5): Minimal withdrawal (1) to worse than ever (5).
  3. 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Were you satisfied with the treatment 1.31  (0.84)
Were you satisfied with withdrawal treatment 2.04  (0.82)
Did the medication help 1.69  (0.93)
7.Secondary Outcome
Title Percentage of Participants Who Adhered to Study Visits.
Hide Description [Not Specified]
Time Frame baseline to end of study (approximately 40 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: percentage of participants
74
8.Secondary Outcome
Title Percentage of Participants With Adherence to Medication (Naltrexone)
Hide Description Participant who took Naltrexone as prescribed.
Time Frame Day 1 to Day 8 (+/- 2 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: percentage of participants
100
9.Secondary Outcome
Title Use of Ancillary Medications.
Hide Description Number of participants that took ancillary medication
Time Frame baseline to week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
35
10.Secondary Outcome
Title Number of Participants That Self Reported Illicit Drug Use
Hide Description Participants reported on any illicit drug use to include Cocaine marijuana opiates
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
Marijuana 10
Cocaine 3
Opiates 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BUP/VLNXT to VIVITROL
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
BUP/VLNXT to VIVITROL
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
BUP/VLNXT to VIVITROL
Affected / at Risk (%)
Total   1/35 (2.86%) 
Psychiatric disorders   
persecutory ideations  1/35 (2.86%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BUP/VLNXT to VIVITROL
Affected / at Risk (%)
Total   6/35 (17.14%) 
General disorders   
Increased Withdrawal Symptoms  6/35 (17.14%) 
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Paolo Mannelli, M.D
Organization: Duke University Medical Center
Phone: 919-681-0613
EMail: paolo.mannelli@dm.duke.edu
Layout table for additonal information
Responsible Party: Paolo Mannelli, Duke University
ClinicalTrials.gov Identifier: NCT01690546    
Other Study ID Numbers: Pro00036909
First Submitted: September 19, 2012
First Posted: September 21, 2012
Results First Submitted: February 22, 2016
Results First Posted: June 1, 2016
Last Update Posted: June 1, 2016