Chronic Low Back PainPhase 2NCT06419439
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
A Phase 2 study testing Ketamine hydrochloride and Brief narrative intervention in people with Chronic Low Back Pain and Depression, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This is a pilot study to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain, Depression
- What is being tested?
- Ketamine hydrochloride and Brief narrative intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with self-report of moderate to severe, high impact chronic low back pain (defined as 4/10 in severity via NRS, present 3 months on most days) and associated pain interference (defined as T-score 60 on the PROMIS Pain Interference measure), and current significant depressive symptoms (defined as a score 11 on the Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR).
- Medically stable (no hospitalizations in the past month lasting 3 days).
- No changes in pain or depression medication regimen in 4 weeks.
- No planned surgery, injections, hospitalizations, or other new interventions for back pain (except for physical therapy or exercise) or depression during the next four months (study duration).
- Participants must have an adult who can drive them home after the ketamine treatments.
Who cannot join
- Inability to speak English due to the narrative intervention being conducted in English.
- Inability or unwillingness to provide written informed consent (e.g. current delirium).
- Current psychotic symptoms, or history of schizophrenia, schizoaffective disorder, and other psychotic disorder.
- Currently participating in another clinical trial for pain or depression.
- Current uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg).
- Known elevated intracranial pressure, cerebral arterial aneurysm, or elevated intraocular pressure.
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- History of cirrhosis or unstable cardiac condition (e.g., decompensated congestive heart failure).
- Any of the following lab values >2x upper limit of normal: alanine transaminase (ALT), aspartate transferase (AST), direct bilirubin, alkaline phosphatase, creatinine; thyroid stimulating hormone (TSH) <2x lower limit of normal or >2x upper limit of normal.
- Positive urine pregnancy test or lack of birth control method in Veterans of childbearing potential.
- Known hypersensitivity to any excipient in the ketamine injection formulation.
- Previously experienced serious adverse effects with ketamine.
- On day of ketamine infusions, a urine drug screen positive for non-prescribed substances(s) (except cannabis) will exclude a participant from receiving ketamine
- Current or previous abuse of ketamine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Victoria D Powell, MD, 734-845-3072, Victoria.Powell2@va.gov
Sarah L Krein, PhD RN, (734) 845-3621, Sarah.Krein@va.gov
About this study
This is a pilot study to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression.
Read the detailed description
Chronic low back pain (CLBP) and depression are top causes of disability in the United States. Veterans are more likely to have both; prevalence is increasing. When CLBP and depression occur together, patients report more functional limitations, unemployment, and higher healthcare spending, and treatment is less successful. Novel approaches simultaneously addressing pain interference and depression symptoms are needed.
This study will involve initial pilot feasibility testing of an intervention designed to help participants with chronic low back pain and depression both reduce pain interference and improve mood. This study will occur in two phases. The initial phase is a open-label single-arm pilot of the combined intervention (ketamine infusions followed by the brief behavioral intervention) in a small sample of Veterans (n=5). The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. The second phase consists of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT.
- Conditions
- Chronic Low Back Pain, Depression
- Being tested
- Ketamine hydrochloride, Minimally Enhanced Usual Care, Brief narrative intervention
- Keywords
- Feasibility Studies, Pilot Projects, Randomized Controlled Trials, Clinical trials, Psychosocial Intervention, Narrative Medicine, Narrative Therapy, Ketamine, Ketamine, therapeutic use, Veterans, Veterans, Research Subjects, Low Back Pain, Recurrent/Chronic, Depression, Hallucinogens, Therapeutic Use
- Medical subject headings
- Depression, Narrative Medicine, Low Back Pain, Recurrence, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine hydrochlorideDrug
Participants in Arms 1, 2, and 3 will receive four twice-weekly ketamine hydrochloride intravenous infusions dosed at 0.5mg/kg.
Minimally Enhanced Usual CareBehavioural
Also called Control
Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression and will be provided to participants in arms 2 and 3 (pilot RCT).
Brief narrative interventionBehavioural
Also called Active/intervention
Participants in Arm 1 (open label pilot) will receive the brief narrative intervention after four ketamine infusions.
Participants in Arm 2 (those randomized after ketamine infusions are complete to the active arm of the pilot RCT) will receive the brief narrative intervention.
| Study group | Role | What they receive |
|---|---|---|
| Open label, single arm pilot | Other | Initial phase: A small open-label, single arm pilot study (n=5) will be conducted to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. All participants in this open-label single arm pilot will receive the intervention (ketamine infusions followed by the brief behavioral intervention). There will be no control condition, randomization, or blinding. Receives: Drug: Ketamine hydrochloride; Behavioral: Brief narrative intervention |
| Intervention + Minimally Enhanced Usual Care | Experimental | Second phase: Intervention arm of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT.
Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression. Receives: Drug: Ketamine hydrochloride; Behavioral: Minimally Enhanced Usual Care; Behavioral: Brief narrative intervention |
| Minimally Enhanced Usual Care Only | Active comparator | Second phase: Control arm of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT.
Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression. Receives: Drug: Ketamine hydrochloride; Behavioral: Minimally Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b)
Pain interference, defined as the extent to which pain impedes enjoyment of and participation in life activities (including cognitive, social, recreational, and self-care activities), will be the primary outcome. Raw scores (range 6 - 30, higher scores indicating more interference) are normed to mean of general population (T-score 50; SD 10); higher T-scores indicate higher pain interference. Minimum clinically important change is 3.0 - 3.5 point reduction in the T-score.
Measured: Visit 7 (8-10 days post randomization)
Secondary outcomes (2)
Pain intensity (Numeric Rating Scale)
Pain intensity will be measured using the NRS, a single-item measure where participants rate their pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). In chronic pain, a reduction of 2 points or 30% is considered a meaningful improvement.
Measured: Visit 7 (8-10 days post randomization)
Depression (Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) )
The Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) is a 16-item rating scale assessing self-report of depressive symptoms. Scores range from 0 - 27, with higher scores indicating more severe depressive symptoms. Reductions of approximately 30% are considered clinically meaningful improvements in depressive symptoms.
Measured: Visit 7 (8-10 days post randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start3 Dec 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study will occur in two phases which will occur sequentially and have different designs. The initial phase is a single-arm open-label, nonrandomized, non-blinded pilot study (n=5). The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. The subsequent phase, informed by these findings, will consist of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Victoria D Powell, MD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419439
- Sponsor's protocol ID
- NURP-001-23F
- Other IDs
- IK2CX002646-01A2
- Status last verified
- Dec 2025
- First submitted
- 23 Apr 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
- ClinicalTrials.gov ID
- NCT06419439
- Acronym / sponsor ID
- NURP-001-23F
- Conditions
- Chronic Low Back Pain, Depression
- Keywords
- Feasibility Studies, Pilot Projects, Randomized Controlled Trials, Clinical trials, Psychosocial Intervention, Narrative Medicine, Narrative Therapy, Ketamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression.
Detailed description
Chronic low back pain (CLBP) and depression are top causes of disability in the United States. Veterans are more likely to have both; prevalence is increasing. When CLBP and depression occur together, patients report more functional limitations, unemployment, and higher healthcare spending, and treatment is less successful. Novel approaches simultaneously addressing pain interference and depression symptoms are needed.
This study will involve initial pilot feasibility testing of an intervention designed to help participants with chronic low back pain and depression both reduce pain interference and improve mood. This study will occur in two phases. The initial phase is a open-label single-arm pilot of the combined intervention (ketamine infusions followed by the brief behavioral intervention) in a small sample of Veterans (n=5). The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. The second phase consists of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study will occur in two phases which will occur sequentially and have different designs. The initial phase is a single-arm open-label, nonrandomized, non-blinded pilot study (n=5). The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. The subsequent phase, informed by these findings, will consist of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT.
| Arm | Type | Receives |
|---|---|---|
| Open label, single arm pilot | Other | Drug: Ketamine hydrochloride, Behavioral: Brief narrative interventionInitial phase: A small open-label, single arm pilot study (n=5) will be conducted to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. All participants in this open-label single arm pilot will receive the intervention (ketamine infusions followed by the brief behavioral intervention). There will be no control condition, randomization, or blinding. |
| Intervention + Minimally Enhanced Usual Care | Experimental | Drug: Ketamine hydrochloride, Behavioral: Minimally Enhanced Usual Care, Behavioral: Brief narrative interventionSecond phase: Intervention arm of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT. Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression. |
| Minimally Enhanced Usual Care Only | Active comparator | Drug: Ketamine hydrochloride, Behavioral: Minimally Enhanced Usual CareSecond phase: Control arm of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT. Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans with self-report of moderate to severe, high impact chronic low back pain (defined as 4/10 in severity via NRS, present 3 months on most days) and associated pain interference (defined as T-score 60 on the PROMIS Pain Interference measure), and current significant depressive symptoms (defined as a score 11 on the Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR).
- Medically stable (no hospitalizations in the past month lasting 3 days).
- No changes in pain or depression medication regimen in 4 weeks.
- No planned surgery, injections, hospitalizations, or other new interventions for back pain (except for physical therapy or exercise) or depression during the next four months (study duration).
- Participants must have an adult who can drive them home after the ketamine treatments.
Key exclusion criteria (13 listed)
- Inability to speak English due to the narrative intervention being conducted in English.
- Inability or unwillingness to provide written informed consent (e.g. current delirium).
- Current psychotic symptoms, or history of schizophrenia, schizoaffective disorder, and other psychotic disorder.
- Currently participating in another clinical trial for pain or depression.
- Current uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg).
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 |
|---|---|---|
| Ketamine hydrochlorideParticipants in Arms 1, 2, and 3 will receive four twice-weekly ketamine hydrochloride intravenous infusions dosed at 0.5mg/kg. | Drug | Intervention + Minimally Enhanced Usual Care, Minimally Enhanced Usual Care Only, Open label, single arm pilot |
| Minimally Enhanced Usual CareAlso: ControlMinimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression and will be provided to participants in arms 2 and 3 (pilot RCT). | Behavioural | Intervention + Minimally Enhanced Usual Care, Minimally Enhanced Usual Care Only |
| Brief narrative interventionAlso: Active/interventionParticipants in Arm 1 (open label pilot) will receive the brief narrative intervention after four ketamine infusions. Participants in Arm 2 (those randomized after ketamine infusions are complete to the active arm of the pilot RCT) will receive the brief narrative intervention. | Behavioural | Intervention + Minimally Enhanced Usual Care, Open label, single arm pilot |
Primary outcome
Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b)
Time frame: Visit 7 (8-10 days post randomization)
Pain interference, defined as the extent to which pain impedes enjoyment of and participation in life activities (including cognitive, social, recreational, and self-care activities), will be the primary outcome. Raw scores (range 6 - 30, higher scores indicating more interference) are normed to mean of general population (T-score 50; SD 10); higher T-scores indicate higher pain interference. Minimum clinically important change is 3.0 - 3.5 point reduction in the T-score.
2 secondary outcomes
Pain intensity (Numeric Rating Scale)
Time frame: Visit 7 (8-10 days post randomization)
Depression (Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) )
Time frame: Visit 7 (8-10 days post randomization)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Victoria D Powell, MD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
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 Ketamine hydrochloride and Brief narrative intervention in people with Chronic Low Back Pain and Depression, 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria D Powell, MD ((734) 845-3072, Victoria.Powell2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b) (time frame: Visit 7 (8-10 days post randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2025.