OsteoarthritisPhase 2LDN-VANCT03008590
Low Dose Naltrexone for Chronic Pain From Arthritis
A Phase 2 study testing Naltrexone in people with Osteoarthritis and Arthritis, Rheumatoid, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Over 100 million Americans report chronic pain. Veterans are disproportionately affected for multiple reasons, including injuries and post-traumatic stress disorder. Treatment for chronic pain is a priority research area for the VA. One of the most common causes of chronic pain is osteoarthritis (OA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria in order to be eligible for enrollment:
- Veteran or otherwise eligible for VA benefits, able to travel to VA Boston
- One or more of the following chronic conditions:
- osteoarthritis
- rheumatoid arthritis
- non-axial spondyloarthritis
Show all 12Show fewer
- Average daily pain interference with function (average of the 7 parts of question 9 on the Brief Pain Inventory) rated at least 4 on a scale of 0-10, and no higher than 9
- No change in medication in the past 8 weeks made with the expectation of improving pain
- No plan to start another medication or a non-pharmacologic treatment regimen likely to affect pain during the next 16 weeks
- Age at least 18
- Registered for medical care in the VA Boston Healthcare System
- Capable of informed consent, and willingness to comply with study procedures, including receipt of weekly phone calls from the study coordinator
Who cannot join
- Any of the following requires exclusion from participation:
- Current use of opioids including tramadol
- Pregnant, breast feeding, or unwilling to engage in contraceptive practices if sexually active and capable of conceiving
- Schizophrenia, bipolar disorder, or poorly controlled depression or anxiety
- Previous use of low-dose naltrexone
- Back pain described by the patient as greater in severity than arthritic pain in a non-axial location
Show all 12Show fewer
- Significant kidney disease, defined as glomerular filtration rate < 30 ml/min
- Liver cirrhosis. There is no specific screening procedure to exclude cirrhosis.
- Painful peripheral neuropathy. There is no specific screening procedure.
- Plan to have surgery during the next 16 weeks
- Inconsistency in self-reporting at the screening visit. BPI, PainDETECT, WOMAC, and PROMIS-29 all contain 0-10 scales of average pain intensity, although the times listed vary from 1-4 weeks. The severity reported on these three scales cannot differ by more than 1.
- Other qualitative circumstances that the investigator feels would make the patient a poor candidate for this clinical trial, such as an unstable social situation or unreliable transportation
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
Official title: Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis
Over 100 million Americans report chronic pain. Veterans are disproportionately affected for multiple reasons, including injuries and post-traumatic stress disorder. Treatment for chronic pain is a priority research area for the VA. One of the most common causes of chronic pain is osteoarthritis (OA). OA is attributable to "wear and tear," but reasons for pain are complex. Inflammatory arthritis (IA) includes multiple severe diseases that affect 2-3% of persons and require treatment with immune-suppressive drugs to prevent joint destruction. Pain often persists despite effective treatment. Pain in arthritis results from multiple sources: inflammation, perception of pain in the joint, and interpretation of pain by the brain. Unfortunately, management of pain in arthritis remains a challenge. Low dose naltrexone is a widely used but unproven "alternative" approach to chronic pain. It is attractive for study because it is safe and is proposed to work on all three pathways that contribute to pain. A small but high-quality clinical trial is needed to determine whether to invest in definitive studies.
Read the detailed description
Chronic pain affects over 100 million Americans, and arthritis is the most common cause. Existing treatments for chronic arthritic pain are only mildly effective, and risks of medications used to treat pain are numerous and continue to be discovered. Treatment of chronic is a high priority research area for VA CSR\&D.
Naltrexone is an opioid antagonist that is FDA approved in an oral daily dose of 50 mg to prevent recidivism in alcoholics. At much lower doses of 4 - 4.5 mg daily, however, it has been shown in small, blinded, randomized trials to improve pain in fibromyalgia, gastrointestinal symptoms in Crohn's disease, and quality of life in multiple sclerosis. The only other published data are case reports in complex regional pain syndrome, low back pain, and scleroderma. However, advocacy of low-dose naltrexone (LDN) by internet-based MDs and patients is high, and since LDN can be prescribed off-label, its use greatly exceeds what is justified by evidence. The drug can be prescribed only via compounding pharmacies, so its use costs a patient ~$40/month.
Among the many unproven treatments that are widely used, LDN is of particular interest because results of surveys of patients are particularly impressive, because it is quite safe, and because its benefit is plausible pharmacologically. There is evidence both for modulation of central pain-processing pathways and for down-regulation of inflammatory pathways in microglia. Considering the diversity of conditions proposed to benefit from LDN and the unequivocal need for better approaches to pain relief in chronic conditions, high-quality clinical trials are needed in both inflammatory and non-inflammatory conditions. This small but placebo-controlled study, powered to detect an effect size as small as that seen with NSAIDs or the most beneficial non-pharmacologic approaches, is proposed as a prerequisite for considering a pivotal trial through the VA Cooperative Studies Program.
The proposed study is a randomized, double-blinded, cross-over, placebo-controlled trial in adults with osteoarthritis or inflammatory arthritis and persistent pain. Sixty patients will be enrolled for 16 weeks, during which they will receive LDN for 8 weeks and placebo for 8 weeks. Widely accepted patient-reported outcome measures will be used. The co-primary endpoints are reduction in pain severity or pain's interference with function during 8 weeks of LDN compared to 8 weeks placebo, using the Brief Pain Inventory. Other patient-reported data will be used both as secondary outcomes and as covariates in analyzing determinants of response to treatment.
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic
- Being tested
- Naltrexone, Placebo
- Keywords
- Pain management, Naltrexone, Controlled clinical trials, randomized
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
One 4.5 mg capsule each evening
PlaceboDrug
One capsule each evening
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone first then placebo | Other | Naltrexone for 8 weeks, then placebo for 8 weeks, blinded cross-over design Receives: Drug: Naltrexone; Drug: Placebo |
| Placebo first then naltrexone | Other | Placebo for 8 weeks, then naltrexone for 8 weeks, blinded cross-over design Receives: Drug: Naltrexone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory - Pain Interference
Sum of 7 questions (each on a 0-10 scale, therefore 0-70 total) on how much pain has interfered with general function, walking ability, mood, normal work, relations with other people, sleep, and enjoyment of life. Higher score is a worse outcome. Results are reported as change from baseline: after 8 weeks of naltrexone, or after 8 weeks of placebo.
Measured: 8 and 16 weeks, ie after 8 weeks naltrexone or 8 weeks placebo
Secondary outcomes (10)
Brief Pain Inventory - Pain Severity
Average severity of pain in the past 7 days (0-10). Higher score is a worse outcome. Results are reported as change from baseline: after 8 weeks naltrexone, and after 8 weeks placebo.
Measured: 8 and16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
painDETECT
Measure of neuropathic pain (0-38). Lower score indicates nociceptive pain, higher score indicates neuropathic pain. Results are reported as change from baseline: after 8 weeks of naltrexone or after 8 weeks placebo.
Measured: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Brief Fatigue Inventory
Questionnaire, severity of fatigue and fatigue's interference with activity (0-10 scales). Higher score is a worse outcome. Results are reported as change from baseline: after 8 weeks naltrexone or after 8 weeks placebo.
Measured: 8 and16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Beck Depression Inventory-II
Questionnaire measuring severity of depression (0-69). Used primarily during screening to exclude enrollment of patients with severe depression, but also as a safety outcome measure during the study. Higher score is a worse outcome. Results are reported as change from baseline: after 8 weeks of naltrexone, or after 8 weeks of placebo
Measured: 8 and16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Clinical Global Impression of Severity (CGI-S)
7-point scale (1-7) of patients' self-reporting of severity during the study. Higher score is a worse outcome. Results are reported as change from baseline: after 8 weeks naltrexone, or after 8 weeks placebo.
Measured: 8 and16 weeks, ie after 8 weeks naltrexone and 8 weeks placebo
Clinical Global Impression of Improvement (CGI-I)
7-point scale (1-7) of patients' self-reporting of improvement or worsening during the study. A higher score is a worse outcome. Results are reported as change from baseline: after 8 weeks naltrexone, or after 8 weeks placebo.
Measured: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Patient Reported Outcomes Measurement Information System Profile (PROMIS-29)
Questionnaire, survey of 29 questions assessing health-related quality of life across 8 domains. The subscores are not added to give a single score. Results would have been reported as change from baseline (after 8 weeks naltrexone, or after 8 weeks placebo), but data were not collected.
Measured: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
C Reactive Protein (CRP)
Blood test for inflammation. Plan was to reported as change from baseline (after 8 weeks naltrexone, or after 8 weeks placebo), but data were not collected.
Measured: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Disease Activity Score (DAS28)
Measure of disease activity in rheumatoid arthritis. Plan was to reported report results as change from baseline (after 8 weeks naltrexone, or after 8 weeks placebo), but data were not collected.
Measured: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Bath Ankylosing Spondylitis Activity Index (BASDAI)
Patient-reported index of disease activity for ankylosing spondylitis. Higher is more severe. Results would have been reported as change from baseline (after 8 weeks naltrexone, or after 8 weeks placebo) but data were not collected.
Measured: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start1 May 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul A. Monach, MD PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008590
- Sponsor's protocol ID
- NURB-008-16S
- Acronym
- LDN-VA
- Status last verified
- Feb 2021
- First submitted
- 22 Dec 2016
- Last updated
- 3 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset containing all the primary study data will be created and shared per VA policies. This dataset will be included as a supplementary file attached to the published manuscript, which in turn will be available through PubMed Central per VA rules. In the event that the study has not been published, the dataset will be made available by other means within 3 years of study completion. The publicly available dataset will not include any identifiers, e.g. age will be included but not birthdate.
Publications
Beaudette-Zlatanova B, Lew RA, Otis JD, Branch-Elliman W, Bacorro E, Dubreuil M, Eyvazzadeh C, Kaur M, Lazzari AA, Libbey C, Monach PA. Pilot Study of Low-dose Naltrexone for the Treatment of Chronic Pain Due to Arthritis: A Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial. Clin Ther. 2023 May;45(5):468-477. doi: 10.1016/j.clinthera.2023.03.013. Epub 2023 Apr 10.
PubMed 37045708
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT03008590
- Acronym / sponsor ID
- LDN-VA / NURB-008-16S
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic
- Keywords
- Pain management, Naltrexone, Controlled clinical trials, randomized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Posted 3 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 100 million Americans report chronic pain. Veterans are disproportionately affected for multiple reasons, including injuries and post-traumatic stress disorder. Treatment for chronic pain is a priority research area for the VA. One of the most common causes of chronic pain is osteoarthritis (OA). OA is attributable to "wear and tear," but reasons for pain are complex. Inflammatory arthritis (IA) includes multiple severe diseases that affect 2-3% of persons and require treatment with immune-suppressive drugs to prevent joint destruction. Pain often persists despite effective treatment. Pain in arthritis results from multiple sources: inflammation, perception of pain in the joint, and interpretation of pain by the brain. Unfortunately, management of pain in arthritis remains a challenge. Low dose naltrexone is a widely used but unproven "alternative" approach to chronic pain. It is attractive for study because it is safe and is proposed to work on all three pathways that contribute to pain. A small but high-quality clinical trial is needed to determine whether to invest in definitive studies.
Detailed description
Chronic pain affects over 100 million Americans, and arthritis is the most common cause. Existing treatments for chronic arthritic pain are only mildly effective, and risks of medications used to treat pain are numerous and continue to be discovered. Treatment of chronic is a high priority research area for VA CSR\&D.
Naltrexone is an opioid antagonist that is FDA approved in an oral daily dose of 50 mg to prevent recidivism in alcoholics. At much lower doses of 4 - 4.5 mg daily, however, it has been shown in small, blinded, randomized trials to improve pain in fibromyalgia, gastrointestinal symptoms in Crohn's disease, and quality of life in multiple sclerosis. The only other published data are case reports in complex regional pain syndrome, low back pain, and scleroderma. However, advocacy of low-dose naltrexone (LDN) by internet-based MDs and patients is high, and since LDN can be prescribed off-label, its use greatly exceeds what is justified by evidence. The drug can be prescribed only via compounding pharmacies, so its use costs a patient ~$40/month.
Among the many unproven treatments that are widely used, LDN is of particular interest because results of surveys of patients are particularly impressive, because it is quite safe, and because its benefit is plausible pharmacologically. There is evidence both for modulation of central pain-processing pathways and for down-regulation of inflammatory pathways in microglia. Considering the diversity of conditions proposed to benefit from LDN and the unequivocal need for better approaches to pain relief in chronic conditions, high-quality clinical trials are needed in both inflammatory and non-inflammatory conditions. This small but placebo-controlled study, powered to detect an effect size as small as that seen with NSAIDs or the most beneficial non-pharmacologic approaches, is proposed as a prerequisite for considering a pivotal trial through the VA Cooperative Studies Program.
The proposed study is a randomized, double-blinded, cross-over, placebo-controlled trial in adults with osteoarthritis or inflammatory arthritis and persistent pain. Sixty patients will be enrolled for 16 weeks, during which they will receive LDN for 8 weeks and placebo for 8 weeks. Widely accepted patient-reported outcome measures will be used. The co-primary endpoints are reduction in pain severity or pain's interference with function during 8 weeks of LDN compared to 8 weeks placebo, using the Brief Pain Inventory. Other patient-reported data will be used both as secondary outcomes and as covariates in analyzing determinants of response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone first then placebo | Other | Drug: Naltrexone, Drug: PlaceboNaltrexone for 8 weeks, then placebo for 8 weeks, blinded cross-over design |
| Placebo first then naltrexone | Other | Drug: Naltrexone, Drug: PlaceboPlacebo for 8 weeks, then naltrexone for 8 weeks, blinded cross-over design |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Veteran or otherwise eligible for VA benefits, able to travel to VA Boston
- One or more of the following chronic conditions:
- Average daily pain interference with function (average of the 7 parts of question 9 on the Brief Pain Inventory) rated at least 4 on a scale of 0-10, and no higher than 9
- No change in medication in the past 8 weeks made with the expectation of improving pain
- No plan to start another medication or a non-pharmacologic treatment regimen likely to affect pain during the next 16 weeks
Key exclusion criteria (12 listed)
- Current use of opioids including tramadol
- Pregnant, breast feeding, or unwilling to engage in contraceptive practices if sexually active and capable of conceiving
- Schizophrenia, bipolar disorder, or poorly controlled depression or anxiety
- Previous use of low-dose naltrexone
- Back pain described by the patient as greater in severity than arthritic pain in a non-axial location
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneOne 4.5 mg capsule each evening | Drug | Naltrexone first then placebo, Placebo first then naltrexone |
| PlaceboOne capsule each evening | Drug | Naltrexone first then placebo, Placebo first then naltrexone |
Primary outcome
Brief Pain Inventory - Pain Interference
Time frame: 8 and 16 weeks, ie after 8 weeks naltrexone or 8 weeks placebo
Sum of 7 questions (each on a 0-10 scale, therefore 0-70 total) on how much pain has interfered with general function, walking ability, mood, normal work, relations with other people, sleep, and enjoyment of life. Higher score is a worse outcome. Results are reported as change from baseline: after 8 weeks of naltrexone, or after 8 weeks of placebo.
10 secondary outcomes
Brief Pain Inventory - Pain Severity
Time frame: 8 and16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
painDETECT
Time frame: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Brief Fatigue Inventory
Time frame: 8 and16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Beck Depression Inventory-II
Time frame: 8 and16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Clinical Global Impression of Severity (CGI-S)
Time frame: 8 and16 weeks, ie after 8 weeks naltrexone and 8 weeks placebo
Clinical Global Impression of Improvement (CGI-I)
Time frame: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Patient Reported Outcomes Measurement Information System Profile (PROMIS-29)
Time frame: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
C Reactive Protein (CRP)
Time frame: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Disease Activity Score (DAS28)
Time frame: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Bath Ankylosing Spondylitis Activity Index (BASDAI)
Time frame: 8 and 16 weeks, ie after 8 weeks naltrexone and after 8 weeks placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37045708Beaudette-Zlatanova B, Lew RA, Otis JD, Branch-Elliman W, Bacorro E, Dubreuil M, Eyvazzadeh C, Kaur M, Lazzari AA, Libbey C, Monach PA. Pilot Study of Low-dose Naltrexone for the Treatment of Chronic Pain Due to Arthritis: A Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial. Clin Ther. 2023 May;45(5):468-477. doi: 10.1016/j.clinthera.2023.03.013. Epub 2023 Apr 10.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset containing all the primary study data will be created and shared per VA policies. This dataset will be included as a supplementary file attached to the published manuscript, which in turn will be available through PubMed Central per VA rules. In the event that the study has not been published, the dataset will be made available by other means within 3 years of study completion. The publicly available dataset will not include any identifiers, e.g. age will be included but not birthdate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A. Monach, MD PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone in people with Osteoarthritis and Arthritis, Rheumatoid, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory - Pain Interference (time frame: 8 and 16 weeks, ie after 8 weeks naltrexone or 8 weeks placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.