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Trial record 99 of 186 for:    BUPRENORPHINE AND NALOXONE

Starting Treatment With Agonist Replacement Therapies (START)

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ClinicalTrials.gov Identifier: NCT00315341
Recruitment Status : Completed
First Posted : April 18, 2006
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Walter Ling, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opiate-related Disorders
Interventions Drug: Buprenorphine/naloxone
Drug: Methadone
Enrollment 1269
Recruitment Details Methadone clinics in California, Oregon, Washington, Pennsylvania, New York, and Connecticut
Pre-assignment Details  
Arm/Group Title Buprenorphine/Nx Methadone
Hide Arm/Group Description Participants received medication for 24 weeks in the active phase of the study. The mean dose of buprenorphine was 22.3 mg. Blood samples for measurement of liver function were taken at baseline and at Weeks 1, 2, 4 8, 12, 16, 20, and 24 with follow-up at Week 32. The mean dose of methadone was 93.2 mg.
Period Title: Overall Study
Started 740 529
Completed 340 391
Not Completed 400 138
Arm/Group Title Buprenorphine/Nx Methadone Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 740 529 1269
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 740 participants 529 participants 1269 participants
37.5  (11.2) 37.3  (10.9) 37.4  (11.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 740 participants 529 participants 1269 participants
Female
238
  32.2%
170
  32.1%
408
  32.2%
Male
502
  67.8%
359
  67.9%
861
  67.8%
1.Primary Outcome
Title Hepatic Safety
Hide Description

Participants were categorized according liver transaminase (ALT, AST) levels in blood comparing the baseline sample to any and all subsequent samples in the following manner:

A: both ALT and AST started at less than or equal to two times the ULN and remained at two times or less ULN throughout the study

B: either ALT or AST started at less than or equal to 2 x ULN and at any point in study exceeded 2 x ULN

C: Either ALT or AST started > 2 x ULN, decreased (both ALT and AST) to < 2 x ULN, and remained < 2 x ULN

D: Either ALT or AST started > 2 x ULN and remained above 2 x ULN throughout the study

Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
evaluable subjects stayed in treatment for 24 weeks and gave at least 4 blood samples for liver function tests during the treatment period
Arm/Group Title Buprenorphine/Nx Methadone
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 340 391
Measure Type: Number
Unit of Measure: participants
ALT - A (low, stays low) 278 318
ALT - B (low, goes high) 41 62
ALT - C (high, goes low, stays low) 4 1
ALT - D (high, stays high) 17 10
AST - A (low, stay low) 291 328
AST - B (low, goes high) 37 54
AST - C (high, goes low, stays low) 3 1
AST - D (high, stays high) 9 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Nx, Methadone
Comments categorized changes in ALT/AST from BL:(1)BL transaminases(both ALT/AST)≤2X upper limit of normal(ULN)& remained at this level;(2)BL transaminases ≤2X ULN(either ALT/AST)but increased(either ALT/AST)above this level at any time;(3)BL transaminases >2X ULN(either ALT/AST)& decreased and remained at ≤2X ULN(both ALT/AST);(4)BL transaminases(both ALT/AST)>2X ULN &remained at this level(both ALT/AST);(5)BL transaminases >2X ULN(either ALT/AST)& increased 2X above this level ever(either ALT/AST).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method shift table analyses
Comments [Not Specified]
Time Frame Adverse events (medical and/or psychiatric) assessment will initiate with participant randomization and will continue through 30 days post last dose of study medication administered. Study staff should contact each participant 30 days after study completion and/or discontinuation of study medication to follow-up on any adverse events continuing at study end and to determine whether the participant experienced any adverse events within the 30 days after discontinuing study medication.
Adverse Event Reporting Description All AEs reported during the course of the study requiring medical attention will be reported to a study physician immediately. A study physician may then meet any participants for whom additional follow-up or AE assessment is indicated. The type of AE, severity of the AE and the relationship of the AE to the study treatments will be assessed by appropriately trained medical personnel and recorded on an AE CRF, according to the procedures described in Section 14.2.
 
Arm/Group Title Buprenorphine/Nx Methadone
Hide Arm/Group Description For the BUP/NX group, all participants will receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg buprenorphine increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant’s clinical need. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens. For the MET group, all participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant’s clinical need with no specific upper limit. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
All-Cause Mortality
Buprenorphine/Nx Methadone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Buprenorphine/Nx Methadone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/727 (5.23%)      45/520 (8.65%)    
Investigations     
death * 1  3/727 (0.41%)  3 1/520 (0.19%)  1
life-threatening * 1  3/727 (0.41%)  3 3/520 (0.58%)  3
hospitalization * 1  38/727 (5.23%)  41 45/520 (8.65%)  50
disability * 1  0/727 (0.00%)  0 4/520 (0.77%)  4
congenital anomaly * 1  1/727 (0.14%)  1 0/520 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedWatch
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Buprenorphine/Nx Methadone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   530/727 (72.90%)      442/520 (85.00%)    
Gastrointestinal disorders     
toothache * 1  49/727 (6.74%)  60 55/520 (10.58%)  72
constipation * 1  49/727 (6.74%)  52 47/520 (9.04%)  51
vomiting * 1  28/727 (3.85%)  28 30/520 (5.77%)  36
gastrointestinal disorders * 1  196/727 (26.96%)  311 174/520 (33.46%)  291
General disorders     
general disorders and administration site conditions * 1  79/727 (10.87%)  99 83/520 (15.96%)  162
Infections and infestations     
nasopharyngitis * 1  119/727 (16.37%)  147 117/520 (22.50%)  165
influenza * 1  35/727 (4.81%)  38 34/520 (6.54%)  37
upper respiratory tract infection * 1  32/727 (4.40%)  38 26/520 (5.00%)  30
infections and infestations * 1  281/727 (38.65%)  470 249/520 (47.88%)  466
Injury, poisoning and procedural complications     
injury, poisoning, and procedural complications * 1  134/727 (18.43%)  238 124/520 (23.85%)  218
Investigations     
alanine aminotransferase increased  1  81/727 (11.14%)  104 70/520 (13.46%)  94
aspartate aminotransferase increased  1  70/727 (9.63%)  78 63/520 (12.12%)  87
gamma glutamyltransferase increased  1  47/727 (6.46%)  54 57/520 (10.96%)  71
weight increased  1  10/727 (1.38%)  10 26/520 (5.00%)  26
investigations * 1  215/727 (29.57%)  564 214/520 (41.15%)  619
Musculoskeletal and connective tissue disorders     
musculoskeletal and connective tissue disorders * 1  135/727 (18.57%)  208 98/520 (18.85%)  136
back pain * 1  50/727 (6.88%)  56 37/520 (7.12%)  43
Nervous system disorders     
nervous system disorders * 1  154/727 (21.18%)  246 106/520 (20.38%)  151
headache * 1  102/727 (14.03%)  132 54/520 (10.38%)  72
Psychiatric disorders     
psychiatric disorders * 1  114/727 (15.68%)  162 89/520 (17.12%)  129
Respiratory, thoracic and mediastinal disorders     
respiratory, thoracic, and mediastinal disorders * 1  82/727 (11.28%)  105 64/520 (12.31%)  80
Skin and subcutaneous tissue disorders     
skin and subcutaneous tissue disorders * 1  75/727 (10.32%)  92 75/520 (14.42%)  98
hyperhidrosis * 1  12/727 (1.65%)  13 38/520 (7.31%)  44
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedWatch
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: Walter Ling, M.D.
Organization: University of California, Los Angeles
Phone: (310) 933-8111
EMail: lwalter@ucla.edu
Layout table for additonal information
Responsible Party: Walter Ling, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00315341     History of Changes
Other Study ID Numbers: NIDA-CTN-0027
U10DA013045 ( U.S. NIH Grant/Contract )
First Submitted: April 16, 2006
First Posted: April 18, 2006
Results First Submitted: May 17, 2013
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017