Trial · NCT04678895
Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
NCT04678895, Phase 2, Recruiting, Dartmouth-Hitchcock Medical Center
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy. Trials, record NCT04678895. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04678895
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
- NCT number
- NCT04678895
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 35 participants, estimated
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- Naltrexone, Placebo
- First posted
- 2020-12-22
- Last updated
- 2026-05-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Pain Disability Index | Enrollment through week 12 | Pain Disability index (PDI) Score measures the degree to which pain interferes with activities. Every item ranges from 0 (no interference) to 10 (total interference). The total PDI score can range from 0 to 70, a higher score indicating more interference with functioning across a range of activities. |
| Primary | Change in Numeric Rating Scale for Pain | Enrollment through week 12 | Percent Change in Numerical Rating Scale (NRS) Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment. NRS is scored between 1-10 with 1 being no pain and 10 being the worst pain one can experience. |
| Secondary | Ratio of Pain Catastrophizing Scores Compared to Change in Pain Disability Index | Questionnaire will be administered on enrollment and compared to final pain score data, approximately 12 weeks. | Assessment of the presence of pain catastrophizing behaviors based on the PCS and their effect in consideration of percent change with the Pain Disability Index. PCS is scored based on 13 questions with values ranging 0 to 4 for a total possible score of 52. The higher the score the more pain catastrophizing is present. Pain Disability index (PDI) Score measures the degree to which pain interferes with activities. Every item ranges from 0 (no interference) to 10 (total interference). The total PDI score can range from 0 to 70, a higher score indicating more interference with functioning across a range of activities. The result of these two measures will be expressed as a ratio of Change in PDI over PCS. If linear, we will use the ratio or an appropriate transformation as indicated by the data. |
| Secondary | Ratio of Pain Catastrophizing Scores Compared to Change in Numeric Rating Scale | Questionnaire will be administered on enrollment and compared to final pain score data, approximately 12 weeks. | Assessment of the presence of pain catastrophizing behaviors based on the PCS and their effect in consideration of percent change with the NRS. PCS is scored based on 13 questions with values ranging 0 to 4 for a total possible score of 52. The higher the score the more pain catastrophizing is present. NRS is scored between 1-10 with 1 being no pain and 10 being the worst pain one can experience. The result of these two measures will be expressed as a ratio of Change in NRS over PCS. If linear, we will use the ratio or an appropriate transformation as indicated by the data. |
| Secondary | Ratio of Pre-treatment Expectations Score Compared to Change in Pain Disability Index | Questionnaire will be administered on enrollment and compared to final pain score data, approximately 12 weeks. | Qualitative assessment of pre-treatment expectations, goals for treatment and confidence in the treatment based on a set of three questions. Each question will be assessed by a healthcare provider and scored between 1 to 5, 1 being low confidence towards treatment and 5 being very high confidence in treatment. Total possible score of 15. This will be compared to Change in Pain Disability Index. Pain Disability index (PDI) Score measures the degree to which pain interferes with activities. Every item ranges from 0 (no interference) to 10 (total interference). The total PDI score can range from 0 to 70, a higher score indicating more interference with functioning across a range of activities. The result of these two measures will be expressed as a ratio of Change in PDI over Pre-treatment Expectations Score. If linear, we will use the ratio or an appropriate transformation as indicated by the data. |
| Secondary | Ratio of Pre-treatment Expectations Compared to Change in Numeric Rating Scale | Questionnaire will be administered on enrollment and compared to final pain score data, approximately 12 weeks. | Qualitative assessment of pre-treatment expectations, goals for treatment and confidence in the treatment based on a set of three questions. Each question will be assessed by a healthcare provider and scored between 1 to 5, 1 being low confidence towards treatment and 5 being very high confidence in treatment. Total possible score of 15. This will be compared to Numeric Rating Scale. NRS is scored between 1-10 with 1 being no pain and 10 being the worst pain one can experience. The result of these two measures will be expressed as a ratio of Change in PDI over Pre-treatment Expectations Score. If linear, we will use the ratio or an appropriate transformation as indicated by the data. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
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.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04678895
GET https://conductscience.org/api/trials/v1/NCT04678895/registered