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Trial record 32 of 186 for:    BUPRENORPHINE AND NALOXONE

Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment

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ClinicalTrials.gov Identifier: NCT02032433
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : January 19, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opioid Use Disorder
Interventions Drug: Extended-Release Naltrexone
Drug: Buprenorphine-Naloxone
Enrollment 570
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Extended-Release Naltrexone Buprenorphine-Naloxone
Hide Arm/Group Description

Extended-Release Naltrexone (Vivitrol)

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)

Buprenorphine-Naloxone (Suboxone)

Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)

Period Title: Overall Study
Started 283 287
Completed 205 225
Not Completed 78 62
Arm/Group Title Extended-Release Naltrexone Buprenorphine-Naloxone Total
Hide Arm/Group Description

Extended-Release Naltrexone (Vivitrol)

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)

Buprenorphine-Naloxone (Suboxone)

Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)

Total of all reporting groups
Overall Number of Baseline Participants 283 287 570
Hide Baseline Analysis Population Description
Adults with DSM-5 OUD with non prescribed opioid use in the past 30 days.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 283 participants 287 participants 570 participants
34.0  (9.5) 33.7  (9.8) 33.9  (9.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 287 participants 570 participants
Female 88 81 169
Male 195 206 401
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 287 participants 570 participants
Hispanic or Latino
45
  15.9%
54
  18.8%
99
  17.4%
Not Hispanic or Latino
238
  84.1%
233
  81.2%
471
  82.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 287 participants 570 participants
American Indian or Alaska Native
2
   0.7%
2
   0.7%
4
   0.7%
Asian
8
   2.8%
1
   0.3%
9
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
29
  10.2%
28
   9.8%
57
  10.0%
White
206
  72.8%
215
  74.9%
421
  73.9%
More than one race
18
   6.4%
14
   4.9%
32
   5.6%
Unknown or Not Reported
20
   7.1%
27
   9.4%
47
   8.2%
Randomization status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 287 participants 570 participants
Early randomization
107
  37.8%
110
  38.3%
217
  38.1%
Late randomization
176
  62.2%
177
  61.7%
353
  61.9%
1.Primary Outcome
Title Time to Relapse (Intent to Treat Population)
Hide Description Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Time Frame Weeks 3-24
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat.
Arm/Group Title Extended-Release Naltrexone Buprenorphine-Naloxone
Hide Arm/Group Description:

Extended-Release Naltrexone (Vivitrol)

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)

Buprenorphine-Naloxone (Suboxone)

Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)

Overall Number of Participants Analyzed 283 287
Median (95% Confidence Interval)
Unit of Measure: weeks
8.4
(3.0 to 23.4)
14.4
(5.1 to 23.4)
2.Primary Outcome
Title Time to Relapse (Per Protocol Population)
Hide Description Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Time Frame Weeks 3-24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population (those successfully inducted onto medication)
Arm/Group Title Extended-Release Naltrexone Buprenorphine-Naloxone
Hide Arm/Group Description:

Extended-Release Naltrexone (Vivitrol)

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)

Buprenorphine-Naloxone (Suboxone)

Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)

Overall Number of Participants Analyzed 204 270
Median (95% Confidence Interval)
Unit of Measure: weeks
20.4
(5.4 to 23.4)
15.2
(5.7 to 23.4)
3.Secondary Outcome
Title Number Successfully Inducted Onto Assigned Study Medication
Hide Description Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.
Time Frame Weeks 0-24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Extended-Release Naltrexone Buprenorphine-Naloxone
Hide Arm/Group Description:

Extended-Release Naltrexone (Vivitrol)

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)

Buprenorphine-Naloxone (Suboxone)

Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)

Overall Number of Participants Analyzed 283 287
Measure Type: Number
Unit of Measure: participants
204 270
4.Secondary Outcome
Title Adverse Events Related to Study Medications
Hide Description Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.
Time Frame Weeks 0-36
Hide Outcome Measure Data
Hide Analysis Population Description
These are treatment emergent adverse events. Treatment emergence is defined as any adverse events that occurred after the study day of induction for those participants inducted onto study medication.
Arm/Group Title Extended-Release Naltrexone Buprenorphine-Naloxone
Hide Arm/Group Description:

Extended-Release Naltrexone (Vivitrol)

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)

Buprenorphine-Naloxone (Suboxone)

Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)

Overall Number of Participants Analyzed 204 270
Measure Type: Number
Unit of Measure: events
115 113
5.Secondary Outcome
Title Opioid Abstinence Over Time While on Study Medication (Subjective)
Hide Description Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.
Time Frame Weeks 0-24
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Extended-Release Naltrexone Buprenorphine-Naloxone
Hide Arm/Group Description:

Extended-Release Naltrexone (Vivitrol)

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)

Buprenorphine-Naloxone (Suboxone)

Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)

Overall Number of Participants Analyzed 204 270
Median (Inter-Quartile Range)
Unit of Measure: days
123
(18 to 144)
87
(20 to 144)
6.Secondary Outcome
Title Alcohol and Other Drug Use, Over Time
Hide Description Self report of alcohol and other drug use by participants using TLFB. At each visit the TLFB was completed for dates going back to the last participant encounter. Confirmatory UDS was done at each in person visit.
Time Frame Weeks 0-36
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Cigarette Smoking
Hide Description Cigarette smoking, tobacco use and craving were assessed via the Fagerstrom Test for Nicotine Dependence (FTND) and the Tobacco Use Questionnaire (part of PhenX) at baseline. Craving was assessed via a Visual Analog Scale (VAS), done at screening, every 4 weeks, and at each follow up visit. Number of cigarettes smoked per day was asked at screening, every 4 weeks, and at each follow up visit.
Time Frame Weeks 0-36
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Opioid Craving Over Time
Hide Description Opioid craving was assessed via a Visual Analog Scale (VAS), completed at screening, weekly during treatment, and at each follow up visit.
Time Frame Weeks 0-36
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Subacute Withdrawal Symptoms Over Time
Hide Description Subacute withdrawal symptoms were assessed via the Subjective Opioid Withdrawal Scale, completed at baseline, before and after induction onto study medication, then weekly for the first 4 weeks, every 4 weeks for weeks 8-24 and at both follow up visits. The Hamilton Depression Scale (HAM-D, 17-item) was completed at screening, weekly for the first 4 weeks and then every four weeks and at both followup visits.
Time Frame Weeks 0-36
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Problems Related to Drug Abuse
Hide Description Assessed via the ASI-Lite modules, completed at baseline, week 24, and at each of the follow up visits. Assessed by teh EuroQuol (EQ-5D), completed at baseline, then every 4 weeks and at each follow up visit.
Time Frame Weeks 0-36
Outcome Measure Data Not Reported
11.Secondary Outcome
Title HIV Risk Behavior Over Time
Hide Description HIV and other risk behaviors are assessed via the Risk Assessment Battery (RAB), assessed at baseline, week 12, end of treatment/ week 24 and at each follow up visit.
Time Frame Weeks 0-36
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Cognitive Function
Hide Description Cognitive function was assessed via the Trails Making Test, Parts A and B, and the Stroop Color-Word Test. Both assessments were completed at baseline, every 4 weeks through the end of treatment/week 24.
Time Frame Weeks 0-24
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Opioid Abstinence Over Time While on Study Medication (Objective)
Hide Description A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.
Time Frame Weeks 0-24
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Extended-Release Naltrexone Buprenorphine-Naloxone
Hide Arm/Group Description:

Extended-Release Naltrexone (Vivitrol)

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)

Buprenorphine-Naloxone (Suboxone)

Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)

Overall Number of Participants Analyzed 204 270
Median (Inter-Quartile Range)
Unit of Measure: Weeks
13
(3 to 21)
11
(3 to 20)
Time Frame Weeks 0-36
Adverse Event Reporting Description Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
 
Arm/Group Title Extended-Release Naltrexone Buprenorphine-Naloxone
Hide Arm/Group Description

Extended-Release Naltrexone (Vivitrol)

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)

Buprenorphine-Naloxone (Suboxone)

Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)

All-Cause Mortality
Extended-Release Naltrexone Buprenorphine-Naloxone
Affected / at Risk (%) Affected / at Risk (%)
Total   3/283 (1.06%)   4/287 (1.39%) 
Show Serious Adverse Events Hide Serious Adverse Events
Extended-Release Naltrexone Buprenorphine-Naloxone
Affected / at Risk (%) Affected / at Risk (%)
Total   41/283 (14.49%)   31/287 (10.80%) 
Eye disorders     
Eye disorders  1  1/283 (0.35%)  0/270 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal disorders  1  1/283 (0.35%)  2/270 (0.74%) 
General disorders     
General disorders and administration site conditions  1  2/283 (0.71%)  2/270 (0.74%) 
Hepatobiliary disorders     
Hepatobiliary disorders  1  0/283 (0.00%)  1/270 (0.37%) 
Infections and infestations     
Infections and infestations  1  7/283 (2.47%)  6/287 (2.09%) 
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications  1  17/283 (6.01%)  8/270 (2.96%) 
Metabolism and nutrition disorders     
Metabolism and nutrition disorders  1  1/283 (0.35%)  0/270 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders  1  0/283 (0.00%)  1/270 (0.37%) 
Nervous system disorders     
Nervous system disorders  1  2/283 (0.71%)  2/270 (0.74%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  0/283 (0.00%)  1/270 (0.37%) 
Psychiatric disorders     
Psychiatric  1  10/283 (3.53%)  12/287 (4.18%) 
Reproductive system and breast disorders     
Reproductive system and breast disorders  1  1/283 (0.35%)  0/270 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic, and mediastinal disorders  1  5/283 (1.77%)  0/270 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Extended-Release Naltrexone Buprenorphine-Naloxone
Affected / at Risk (%) Affected / at Risk (%)
Total   118/283 (41.70%)   135/287 (47.04%) 
Blood and lymphatic system disorders     
Blood and lymphatic system disorders  1  1/283 (0.35%)  0/287 (0.00%) 
Cardiac disorders     
Cardiac disorders  1  1/283 (0.35%)  0/287 (0.00%) 
Ear and labyrinth disorders     
Ear and labyrinth disorders  1  1/283 (0.35%)  1/287 (0.35%) 
Eye disorders     
Eye disorders  1  6/283 (2.12%)  3/287 (1.05%) 
Gastrointestinal disorders     
Gastrointestinal  1  36/283 (12.72%)  58/287 (20.21%) 
General disorders     
General Disorders and Administration Site Conditions  1  10/283 (3.53%)  21/287 (7.32%) 
Hepatobiliary disorders     
Hepatbiliary disorders  1  1/283 (0.35%)  1/287 (0.35%) 
Immune system disorders     
Immune system disorders  1  0/283 (0.00%)  1/287 (0.35%) 
Infections and infestations     
Infections and infestations  2  22/283 (7.77%)  22/287 (7.67%) 
Injury, poisoning and procedural complications     
Injury poisoning and procedural complications  1  18/283 (6.36%)  22/287 (7.67%) 
Investigations     
Investigations  1  10/283 (3.53%)  11/287 (3.83%) 
Metabolism and nutrition disorders     
Metabolism and nutrition  1  6/283 (2.12%)  4/287 (1.39%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders  1  16/283 (5.65%)  15/287 (5.23%) 
Nervous system disorders     
Nervous system disorders  2  29/283 (10.25%)  27/287 (9.41%) 
Product Issues     
Product issues  1  0/283 (0.00%)  1/287 (0.35%) 
Psychiatric disorders     
Psychiatric  1  29/283 (10.25%)  22/287 (7.67%) 
Renal and urinary disorders     
Renal and urinary disorders  1  4/283 (1.41%)  5/287 (1.74%) 
Reproductive system and breast disorders     
Reproductive system and breast disorders  1  2/283 (0.71%)  3/287 (1.05%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorders  1  7/283 (2.47%)  7/287 (2.44%) 
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders  1  9/283 (3.18%)  7/287 (2.44%) 
Social circumstances     
Social circumstances  1  1/283 (0.35%)  0/287 (0.00%) 
Surgical and medical procedures     
Surgical and medical procedures  1  0/283 (0.00%)  3/287 (1.05%) 
Vascular disorders     
Vascular disorders  1  1/283 (0.35%)  6/287 (2.09%) 
1
Term from vocabulary, MedDRA (19.0)
2
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
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: John Rotrosen
Organization: NYU School of Medicine
Phone: 646-754-4763
EMail: john.rotrosen@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02032433     History of Changes
Other Study ID Numbers: 12-03133
UG1DA013035 ( U.S. NIH Grant/Contract )
First Submitted: December 30, 2013
First Posted: January 10, 2014
Results First Submitted: November 24, 2017
Results First Posted: January 19, 2018
Last Update Posted: July 6, 2018