Trial · NCT02741076
Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain
NCT02741076, Phase 4, Terminated, Member Companies of the Opioid PMR Consortium; results first posted 2019-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain. Trials, record NCT02741076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02741076
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain
- NCT number
- NCT02741076
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 44 participants, actual
- Lead sponsor
- Member Companies of the Opioid PMR Consortium
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Interventions
- Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
- First posted
- 2016-04-18
- Last updated
- 2019-11-06
- Results first posted
- 2019-11-06
- Limitations and caveats
This study was terminated because it could not recruit the planned study population. Randomized study participants were too few to show changes in pain intensity scores or clinical effects. The safety profile reflects current prescribing information.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | From baseline to the 1 week period prior to the Week 12 visit | Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing. PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. |
| Secondary | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | From baseline to weeks 4, 8, 16, 20, and 24 | Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing. PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. |
| Secondary | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Weeks 12 and 24 | Percent pain intensity difference (PID) relative to baseline is defined as 100\* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. This outcome measure applies only to Suboptimal Responders. |
| Secondary | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Weeks 12 and 24 | Percent pain intensity difference (PID) relative to baseline is defined as 100\* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. This outcome measure applies only to Optimal Responders. |
| Secondary | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Weeks 12 and 24 | The MOS Sleep Scale is a 12-item questionnaire which measures sleep quality in 7 scales over the past 4 weeks: sleep disturbance, snoring, sleep short of breath or headache, sleep adequacy, sleep somnolence, and 2 sleep problems indexes. In addition, the average hours of sleep over the past 4 weeks is recorded as a raw measure and also coded as an optimal sleep index. The MOS is scored and the sleep scales calculated according to the MOS Sleep Scale User's Manual v1.0 (Spritzer and Hays, 2003). The scores on the dimensions and the sleep indices were converted to a 0-100 scale, with higher scores reflecting more of the attribute implied by the name (e.g. greater sleep disturbance, greater sleep adequacy of sleep). |
| Secondary | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | 4 weeks prior to baseline and prior to 12 and 24 week visits | Optimal Sleep Index is based on the average number of hours of sleep each night during the past 4 weeks. Index=1 represents 7-8 hours and Index=0 represents \< 7 hours or \> 8 hours. |
| Secondary | Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | Weeks 12 and 24 | The PHQ-8 is an 8-item questionnaire that aims at assessing the level of mood of a subject. Each item is scored from 0 = "not at all" to 3= "nearly every day"; the total score, which is the sum of the score for each item, can be from 0 to 24. A score ≥10 is considered major depression and ≥20 is severe major depression. |
| Secondary | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Baseline, 12 and 24 week visit | The PHQ-8 is an 8-item questionnaire that aims at assessing the level of depression of a subject. Each item is scored from 0 = "not at all" to 3= "nearly every day"; the total score, which is the sum of the scores for each item, can be from 0 to 24. A score \>= 10 is considered major depression and \>= 20 is severe major depression. |
| Secondary | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Baseline and weeks 12, 24 | The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments.The EQ-5D-5L measures quality of life in 5 dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. Each is rated in 5 levels from no problems/pain/anxiety to being unable/extreme pain/extreme anxiety. The responses for each category are summarized by treatment and visit with frequencies and percentages reporting each level. |
| Secondary | Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Baseline to 12 and 24 week visit | The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments. The visual analog scale (VAS) rates the subject's health on a 0-100 scale from the worst imaginable health state to the best imaginable health state. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | From baseline to the 1 week period prior to the Week 12 visit | Intent to Treat Population | Score on a scale | MEAN |
| SECONDARY | Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | From baseline to weeks 4, 8, 16, 20, and 24 | Intent to Treat Population | Score on a scale | MEAN |
| SECONDARY | Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Weeks 12 and 24 | Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS) | Weeks 12 and 24 | Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS) | Weeks 12 and 24 | Intent to Treat Population | Score on a scale | MEAN |
| SECONDARY | Participants Sleep Quantity Measured by Medical Outcomes Study (MOS) | 4 weeks prior to baseline and prior to 12 and 24 week visits | Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8) | Weeks 12 and 24 | Intent to Treat Population | Score on a scale | MEAN |
| SECONDARY | Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8) | Baseline, 12 and 24 week visit | Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument | Baseline and weeks 12, 24 | Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument) | Baseline to 12 and 24 week visit | Intent to Treat Population | Score on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group670
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | Structured Discontinuation Opioid Therapy Suboptimal Responder | -0.2198 | Standard Deviation 0.83544 | Score on a scale | |
| Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | Continuation of Opioid Therapy Suboptimal Responder | -0.3328 | Standard Deviation 1.00514 | Score on a scale | |
| Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | Structured Discontinuation Opioid Therapy Optimal Responder | 0.3750 | Standard Deviation 1.28794 | Score on a scale | |
| Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | Continuation of Opioid Therapy Optimal Responder | 1.00 | Standard Deviation 0.00 | Score on a scale | |
| Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | Structured Discontinuation Opioid Therapy Suboptimal Responder | 4 weeks | -0.1123 | Standard Deviation 0.77962 | Score on a scale |
| Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | Continuation of Opioid Therapy Suboptimal Responder | 4 weeks | -0.1413 | Standard Deviation 0.99386 | Score on a scale |
| Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | Structured Discontinuation Opioid Therapy Optimal Responder | 4 weeks | 0.4940 | Standard Deviation 0.64818 | Score on a scale |
| Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | Continuation of Opioid Therapy Optimal Responder | 4 weeks | 0.3143 | Standard Deviation 0.38951 | Score on a scale |
| Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | Structured Discontinuation Opioid Therapy Suboptimal Responder | 8 weeks | -0.3671 | Standard Deviation 0.86810 | Score on a scale |
| Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS) | Continuation of Opioid Therapy Suboptimal Responder | 8 weeks | 0.0984 | Standard Deviation 0.62794 | Score on a scale |
1 to 10 of 670Source ClinicalTrials.gov
See all 670 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Structured Discontinuation Opioid Therapy Suboptimal Responder | 13 | |
| Overall Study | STARTED | Continuation of Opioid Therapy Suboptimal Responder | 12 | |
| Overall Study | STARTED | Structured Discontinuation Opioid Therapy Optimal Responder | 3 | |
| Overall Study | STARTED | Continuation of Opioid Therapy Optimal Responder | 4 | |
| Overall Study | COMPLETED | Structured Discontinuation Opioid Therapy Suboptimal Responder | 10 | |
| Overall Study | COMPLETED | Continuation of Opioid Therapy Suboptimal Responder | 7 | |
| Overall Study | COMPLETED | Structured Discontinuation Opioid Therapy Optimal Responder | 1 | |
| Overall Study | COMPLETED | Continuation of Opioid Therapy Optimal Responder | 2 | |
| Overall Study | NOT COMPLETED | Structured Discontinuation Opioid Therapy Suboptimal Responder | 3 | |
| Overall Study | NOT COMPLETED | Continuation of Opioid Therapy Suboptimal Responder | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Drug Screen Positive | Investigations | Structured Discontinuation Opioid Therapy Suboptimal Responder | 2 | 13 | |
| other | Drug Screen Positive | Investigations | Continuation of Opioid Therapy Suboptimal Responder | 1 | 12 | |
| other | Drug Screen Positive | Investigations | Structured Discontinuation Opioid Therapy Optimal Responder | 0 | 3 | |
| other | Drug Screen Positive | Investigations | Continuation of Opioid Therapy Optimal Responder | 0 | 4 | |
| other | Urine Alcohol Test Positive | Investigations | Structured Discontinuation Opioid Therapy Suboptimal Responder | 1 | 13 | |
| other | Urine Alcohol Test Positive | Investigations | Continuation of Opioid Therapy Suboptimal Responder | 1 | 12 | |
| other | Urine Alcohol Test Positive | Investigations | Structured Discontinuation Opioid Therapy Optimal Responder | 0 | 3 | |
| other | Urine Alcohol Test Positive | Investigations | Continuation of Opioid Therapy Optimal Responder | 0 | 4 | |
| other | Liver Function Test Abnormal | Investigations | Structured Discontinuation Opioid Therapy Suboptimal Responder | 1 | 13 | |
| other | Liver Function Test Abnormal | Investigations | Continuation of Opioid Therapy Suboptimal Responder | 0 | 12 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Structured Discontinuation Opioid Therapy Suboptimal Responder | 0 | 13 |
| Total, all-cause mortality | Continuation of Opioid Therapy Suboptimal Responder | 0 | 12 |
| Total, all-cause mortality | Structured Discontinuation Opioid Therapy Optimal Responder | 0 | 3 |
| Total, all-cause mortality | Continuation of Opioid Therapy Optimal Responder | 0 | 4 |
| Total, other adverse events | Structured Discontinuation Opioid Therapy Suboptimal Responder | 9 | 13 |
| Total, other adverse events | Continuation of Opioid Therapy Suboptimal Responder | 7 | 12 |
| Total, other adverse events | Structured Discontinuation Opioid Therapy Optimal Responder | 2 | 3 |
| Total, other adverse events | Continuation of Opioid Therapy Optimal Responder | 1 | 4 |
| Total, serious adverse events | Structured Discontinuation Opioid Therapy Suboptimal Responder | 1 | 13 |
| Total, serious adverse events | Continuation of Opioid Therapy Suboptimal Responder | 0 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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