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Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

This study has been completed.
Sponsor:
Collaborators:
Arthritis Foundation
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01502644
First received: December 28, 2011
Last updated: June 14, 2017
Last verified: June 2017
Results First Received: April 7, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Chronic Low Back Pain
Degenerative Disc Disease
Depression
Anxiety
Interventions: Drug: Oxycodone
Drug: Morphine
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Volunteers with chronic low back pain (CLBP) and psychiatric illness (comorbid negative affect [NA]) were recruited to participate in this trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
NA level determined by Hospital Anxiety and Depression Scale (HADS) score: Anxiety and Depression subscales with 7 questions each, each question scored 0 (least) to 3 (greatest) amount of anxiety/depression, total score 0-21. High NA=score ≥9 on each subscale, Moderate NA=score ≥6 to ≤8 on each subscale, Low NA=HADS score ≤5 on each subscale.

Reporting Groups
  Description
Enrolled at Visit 1 All participants who satisfied pre-screening requirements and were enrolled at Visit 1.
Low NA Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
Moderate NA Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
High NA Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.

Participant Flow for 2 periods

Period 1:   Enrolled at Visit 1 After Pre-screening
    Enrolled at Visit 1   Low NA   Moderate NA   High NA
STARTED   81   0   0   0 
COMPLETED   72 [1]   0   0   0 
NOT COMPLETED   9   0   0   0 
Illegal Drugs in Urine Drug Test                1                0                0                0 
History of Opioid Substance Use Disorder                2                0                0                0 
Declined to Participate further                6                0                0                0 
[1] Participants who completed Visit 1 were assigned to 1 of the 3 NA groups for remainder of the trial

Period 2:   Assigned to NA Groups
    Enrolled at Visit 1   Low NA   Moderate NA   High NA
STARTED   0   30   10   32 
COMPLETED   0   24 [1]   7 [1]   24 [1] 
NOT COMPLETED   0   6   3   8 
Drop Out due to Side Effects                0                6                2                7 
Illegal Drugs in Urine Drug Test                0                0                1                1 
[1] Completed = completed at least 50% of the opioid treatment period (at least 10 weeks of treatment)



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent-to-Treat Population, all participants who completed at least 50% of the opioid treatment period (at least 10 weeks of treatment).

Reporting Groups
  Description
Low NA Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
Moderate NA Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
High NA Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
Total Total of all reporting groups

Baseline Measures
   Low NA   Moderate NA   High NA   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   7   24   55 
Age 
[Units: Years]
Mean (Standard Deviation)
 55  (10.9)   54  (11.7)   49  (12.2)   51.8  (11.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      16  66.7%      3  42.9%      14  58.3%      33  60.0% 
Male      8  33.3%      4  57.1%      10  41.7%      22  40.0% 


  Outcome Measures

1.  Primary:   Percent Change in Average Daily Pain Score   [ Time Frame: Baseline and Week 20 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ajay D. Wasan, M.D., M.Sc.
Organization: Brigham and Women’s Hospital
e-mail: awasan@partners.org



Responsible Party: Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01502644     History of Changes
Other Study ID Numbers: 2007P-001047
5K23DA020681-05 ( U.S. NIH Grant/Contract )
Study First Received: December 28, 2011
Results First Received: April 7, 2017
Last Updated: June 14, 2017