Low Dose Naltrexone for Glioma Patients
NCT01303835, Phase 2, Completed, Katy Peters; results first posted 2015-06-26
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Low Dose Naltrexone for Glioma Patients | ClinicalTrials.gov |
| NCT number | NCT01303835 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 110 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Katy Peters | ClinicalTrials.gov |
| Conditions | Malignant Glioma | ClinicalTrials.gov |
| Interventions | LDN, Placebo | ClinicalTrials.gov |
| First posted | 2011-02-25 | ClinicalTrials.gov |
| Last updated | 2015-07-17 | ClinicalTrials.gov |
| Results first posted | 2015-06-26 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Baseline and 16 weeks | The difference in QoL scores between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. QoL instruments included are listed below. Higher scores indicate more favorable outcomes unless otherwise indicated. * Functional Assessment of Cancer Therapy-Brain (FACT-Br) measures general QoL reflecting symptoms associated with brain malignancies (range 0-132) * Functional Assessment of Chronic Illness Therapy (FACIT-F) measures level of fatigue during patients' usual daily activities (range 0-52) * Epworth Sleepiness Scale measures level of daytime sleepiness. Note that higher scores indicate a greater level of sleepiness (range 0-24) * Medical Outcomes Survey (MOS) measures QoL including physical, mental and general health via 8 domains (range 0-100 for each domain) * Zung Self-Rating Depression Scale quantifies the depressed status of a patient. Lower scores indicate more favorable outcome (range 20-80) A difference | ClinicalTrials.gov |
| Secondary | Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From Baseline | Baseline and 16 weeks | Patients completed the 6-minute walk test (6MWT) at each QoL measurement assessment. The 6 minute walk test is a measure of functional capacity in which the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes is measured. The mean difference in distance traveled (in meters) between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in distance traveled, while a difference less than 0 indicates a decrease. | ClinicalTrials.gov |
| Secondary | Effects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline | Baseline and 16 weeks | Patients completed neurocognitive testing at each QoL measurement assessment. Neurocognitive function was measured via a computerized neurocognitive test battery called CNS Vital Signs. The battery consists of 7 tests that assess verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention, and continuous performance. The battery provides scores over 9 domains with higher scores indicating better performance. Scores were normalized to a standard score mean of 100 and standard deviation of 15 using a normative sample. The mean difference in score in each domain between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in mean score, while a difference less than 0 indicates a decrease in mean score. | ClinicalTrials.gov |
Outcomes 3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Baseline and 16 weeks | This analysis only includes those patients who completed both the initial QOL assessments and the 16 week QoL assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks. | Scores on a Scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From Baseline | Baseline and 16 weeks | This analysis only includes those patients who completed both the initial 6MWT assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks. | Meters | MEAN | ClinicalTrials.gov |
| SECONDARY | Effects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline | Baseline and 16 weeks | This analysis only includes those patients who completed both the initial CNS Vital Signs assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks. | Scores on a Scale | MEAN | ClinicalTrials.gov |
Results by group 44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Low Dose Naltrexone (LDN) | FACT-Brain Trial Outcome Index (TOI) | -3.73 | Standard Deviation 22.85 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Placebo | FACT-Brain Trial Outcome Index (TOI) | -6.06 | Standard Deviation 21.72 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Low Dose Naltrexone (LDN) | FACIT-Fatigue | -4.22 | Standard Deviation 11.07 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Placebo | FACIT-Fatigue | -4.1 | Standard Deviation 13.41 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Low Dose Naltrexone (LDN) | Epworth Sleepiness Scale | 3.47 | Standard Deviation 4.37 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Placebo | Epworth Sleepiness Scale | 0.81 | Standard Deviation 3.45 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Low Dose Naltrexone (LDN) | MOS - Physical Functioning | -5.54 | Standard Deviation 34.41 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Placebo | MOS - Physical Functioning | -3.42 | Standard Deviation 29.75 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Low Dose Naltrexone (LDN) | MOS - Role Limitations due to Physical Health | 0 | Standard Deviation 51.71 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Placebo | MOS - Role Limitations due to Physical Health | 20.39 | Standard Deviation 41.86 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Low Dose Naltrexone (LDN) | MOS - Role Limitations due to Emotional Issues | 2.69 | Standard Deviation 49.31 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Placebo | MOS - Role Limitations due to Emotional Issues | 12.3 | Standard Deviation 56.11 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Low Dose Naltrexone (LDN) | MOS - Energy/Fatigue | -6.22 | Standard Deviation 29.8 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Placebo | MOS - Energy/Fatigue | -4.61 | Standard Deviation 29.76 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Low Dose Naltrexone (LDN) | MOS - Emotional Well Being | 3.5 | Standard Deviation 21.4 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Placebo | MOS - Emotional Well Being | -1.89 | Standard Deviation 15.64 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Low Dose Naltrexone (LDN) | MOS - Social Functioning | 1.34 | Standard Deviation 32.38 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Placebo | MOS - Social Functioning | 7.87 | Standard Deviation 41.57 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Low Dose Naltrexone (LDN) | MOS - Pain | 10.41 | Standard Deviation 27.12 | Scores on a Scale | ClinicalTrials.gov |
| Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline | Placebo | MOS - Pain | 2.39 | Standard Deviation 24.92 | Scores on a Scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Naltrexone | 54 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo | 56 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Naltrexone | 35 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo | 31 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Naltrexone | 19 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo | 25 | ClinicalTrials.gov |
Adverse events 356
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 | Source |
|---|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Naltrexone | 18 | 54 | ClinicalTrials.gov | |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 25 | 56 | ClinicalTrials.gov | |
| other | Chest pain - cardiac | Cardiac disorders | Naltrexone | 1 | 54 | ClinicalTrials.gov | |
| other | Chest pain - cardiac | Cardiac disorders | Placebo | 0 | 56 | ClinicalTrials.gov | |
| other | Conduction disorder | Cardiac disorders | Naltrexone | 1 | 54 | ClinicalTrials.gov | |
| other | Conduction disorder | Cardiac disorders | Placebo | 0 | 56 | ClinicalTrials.gov | |
| other | Sinus bradycardia | Cardiac disorders | Naltrexone | 0 | 54 | ClinicalTrials.gov | |
| other | Sinus bradycardia | Cardiac disorders | Placebo | 1 | 56 | ClinicalTrials.gov | |
| other | Ventricular tachycardia | Cardiac disorders | Naltrexone | 0 | 54 | ClinicalTrials.gov | |
| other | Ventricular tachycardia | Cardiac disorders | Placebo | 1 | 56 | ClinicalTrials.gov | |
| other | Blurred vision | Eye disorders | Naltrexone | 2 | 54 | ClinicalTrials.gov | |
| other | Blurred vision | Eye disorders | Placebo | 5 | 56 | ClinicalTrials.gov | |
| other | Eye disorders - Other, specify: VISUAL FIELD CUT IN BOTH LOWER QUADRANTS | Eye disorders | Naltrexone | 0 | 54 | ClinicalTrials.gov | |
| other | Eye disorders - Other, specify: VISUAL FIELD CUT IN BOTH LOWER QUADRANTS | Eye disorders | Placebo | 1 | 56 | ClinicalTrials.gov | |
| other | Abdominal pain | Gastrointestinal disorders | Naltrexone | 1 | 54 | ClinicalTrials.gov | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 56 | ClinicalTrials.gov | |
| other | Constipation | Gastrointestinal disorders | Naltrexone | 20 | 54 | ClinicalTrials.gov | |
| other | Constipation | Gastrointestinal disorders | Placebo | 20 | 56 | ClinicalTrials.gov | |
| other | Diarrhea | Gastrointestinal disorders | Naltrexone | 2 | 54 | ClinicalTrials.gov | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 6 | 56 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Naltrexone | ClinicalTrials.gov | ||
| Total, all-cause mortality | Placebo | ClinicalTrials.gov | ||
| Total, other adverse events | Naltrexone | 51 | 54 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 54 | 56 | ClinicalTrials.gov |
| Total, serious adverse events | Naltrexone | 12 | 54 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 17 | 56 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 35001215 | DERIVED | PubMed |
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Naltrexone vs Placebo: serious adverse events | Trial comparisons |
Tests 1
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 | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)