Chronic Lower Back Pain (CLBP)Phase 1/2PATNCT07846020
Mechanistic Evaluation of Polypharmacy Effects for Pain
A Phase 1/2 study of Chronic Lower Back Pain (CLBP), run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This is a single-group, within-subject, double-blind, double-dummy, placebo-controlled study evaluating whether gabapentin (Neurontin) changes the analgesic, safety, and subjective effects of the opioid hydromorphone (Dilaudid) when the two are combined. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Lower Back Pain (CLBP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2027to 1 Apr 2032
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Lifetime history of opioid use
- Medically cleared to take study medications
- Chronic Lower Back Pain
- Agree to use effective form of contraception throughout enrollment
Who cannot join
- Pregnant or breastfeeding
- Have evidence of physical dependence on or current use of any central nervous system depressants including but not limited to alcohol, benzodiazepines, opioids, gabapentinoids, or barbiturates
- Past 30-day use of certain pain medications
- Evidence of past 7-day nonmedical drug use
- Known hypersensitvity, allergy to, or history of adverse reactions to study medications
- Are currently taking a medication or have a condition that is contraindicated with either study medication
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- Have evidence of current or past significant medical/psychiatric illness
- Have a history of clinically significant cardiac arrhythmias or vasospastic disease
- Have evidence of renal or hepatic impairment
- Current suicidal ideation or behavior, or a history of a suicide attempt within the past 2 years
- Have any condition that may increases the risk for respiratory depression
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
Kahlert Institute for Addiction Medicine
Baltimore, Maryland, 21201
About this study
Official title: Mechanistic Evaluation of Gabapentin and Opioid Polypharmacy
This is a single-group, within-subject, double-blind, double-dummy, placebo-controlled study evaluating whether gabapentin (Neurontin) changes the analgesic, safety, and subjective effects of the opioid hydromorphone (Dilaudid) when the two are combined.
Read the detailed description
This is a human laboratory systematic examination of whether adding the FDA-approved gabapentin (Neurontin; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) will change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with chronic lower back pain and no history of substance use disorder. Study subjects and staff are blinded to the study drugs and the class of drugs under investigation and are informed that subjects may receive opioids, stimulants, gabapentinoids, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. Sessions last up to 8-hours in an outpatient setting. Primary outcomes are collected from participants prior to dosing and at several hour periods post-dosing.
- Conditions
- Chronic Lower Back Pain (CLBP)
- Being tested
- Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)Drug
Within-subject double-blind, double-dummy, study design wherein all participants received all drug combinations (Placebo + Placebo, Hydromorphone + Placebo, Low Dose Gabapentin + Placebo, High Dose Gabapentin + Placebo, Low Dose Gabapentin + Hydromorphone, High Dose Gabapentin + Hydromorphone) in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
| Study group | Role | What they receive |
|---|---|---|
| Placebo hydromorphone, Placebo gabapentin | Placebo comparator | 0mg oral hydromorphone, 0mg oral gabapentin Receives: Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) |
| Active hydromorphone, Low dose gabapentin | Experimental | 4mg oral hydromorphone, 300mg oral gabapentin Receives: Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) |
| Active hydromorphone, High dose gabapentin | Experimental | 4mg oral hydromorphone, 900mg oral gabapentin Receives: Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) |
| Placebo hydromorphone, Low dose gabapentin | Active comparator | 0mg oral hydromorphone, 300mg oral gabapentin Receives: Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) |
| Placebo hydromorphone, High dose gabapentin | Active comparator | 0mg oral hydromorphone, 900mg oral gabapentin Receives: Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) |
| Active hydromorphone, placebo gabapentin | Active comparator | 4mg oral hydromorphone, 0mg gabapentin Receives: Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak change from baseline Drug Effect
Peak self-reported "Drug Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Drug Effect" on a visual anaogue scale (0-100)
Measured: 8 hour study sessions
Peak change from baseline Good Effect
Peak self-reported "Good Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Good Effect" on a visual anaogue scale (0-100), where lower scores indicate no effect and greater scores indicate maximum effect.
Measured: Baseline (0.5 hours before drug administration) and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 8 hours after drug administration
Peak Cold Pressor Test Tolerance change from baseline score
Peak Cold Pressor Test Tolerance Score minus baseline Peak Cold Pressor Test Tolerance score. Outcome ranges from 0-60 seconds, 0 indicating low analgesic effect and 60 indicating high analgesic effects.
Measured: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Cold Pressor Test Threshold change from baseline score
Peak Cold Pressor Test Threshold Score minus baseline Peak Cold Pressor Test Threshold score. Outcome ranges from 0-60 seconds, 0 indicating low analgesic effect and 60 indicating high analgesic effects.
Measured: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Heat Pain with Capsaicin Threshold change from baseline score
Peak Heat Pain with Capsaicin Threshold score minus baseline Peak Heat Pain with Capsaicin Threshold score. Outcome ranges from 0-100, 0 indicating no pain and 100 indicating extreme pain.
Measured: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Heat Pain with Capsaicin Tolerance Change from Baseline Score
Peak Heat Pain with Capsaicin Tolerance score minus baseline Peak Heat Pain with Capsaicin Tolerance score. Outcome ranges from 0-100, 0 indicating no pain and 100 indicating extreme pain.
Measured: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak change from baseline Bad Effect
Peak self-reported "Bad Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Bad Effect" on a visual anaogue scale (0-100) where lower scores indicate no effect and greater scores indicate maximum effect.
Measured: Baseline (0.5 hours before drug administration) and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 8 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start15 Jan 2027 (estimated)
- Primary completion15 Jan 2032 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject test of blinded study medications
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Cecilia Bergeria, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846020
- Sponsor's protocol ID
- HP-00118502
- Other IDs
- R01DA061796
- Acronym
- PAT
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Evaluation of Gabapentin and Opioid Polypharmacy
- ClinicalTrials.gov ID
- NCT07846020
- Acronym / sponsor ID
- PAT / HP-00118502
- Conditions
- Chronic Lower Back Pain (CLBP)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 Jan 2032 (estimated)
- Study completion
- 1 Apr 2032 (estimated)
- First posted
- 29 Sep 2026 (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 single-group, within-subject, double-blind, double-dummy, placebo-controlled study evaluating whether gabapentin (Neurontin) changes the analgesic, safety, and subjective effects of the opioid hydromorphone (Dilaudid) when the two are combined.
Detailed description
This is a human laboratory systematic examination of whether adding the FDA-approved gabapentin (Neurontin; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) will change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with chronic lower back pain and no history of substance use disorder. Study subjects and staff are blinded to the study drugs and the class of drugs under investigation and are informed that subjects may receive opioids, stimulants, gabapentinoids, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. Sessions last up to 8-hours in an outpatient setting. Primary outcomes are collected from participants prior to dosing and at several hour periods post-dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Within-subject test of blinded study medications
| Arm | Type | Receives |
|---|---|---|
| Placebo hydromorphone, Placebo gabapentin | Placebo comparator | Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)0mg oral hydromorphone, 0mg oral gabapentin |
| Active hydromorphone, Low dose gabapentin | Experimental | Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)4mg oral hydromorphone, 300mg oral gabapentin |
| Active hydromorphone, High dose gabapentin | Experimental | Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)4mg oral hydromorphone, 900mg oral gabapentin |
| Placebo hydromorphone, Low dose gabapentin | Active comparator | Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)0mg oral hydromorphone, 300mg oral gabapentin |
| Placebo hydromorphone, High dose gabapentin | Active comparator | Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)0mg oral hydromorphone, 900mg oral gabapentin |
| Active hydromorphone, placebo gabapentin | Active comparator | Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)4mg oral hydromorphone, 0mg gabapentin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years old
- Lifetime history of opioid use
- Medically cleared to take study medications
- Chronic Lower Back Pain
- Agree to use effective form of contraception throughout enrollment
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding
- Have evidence of physical dependence on or current use of any central nervous system depressants including but not limited to alcohol, benzodiazepines, opioids, gabapentinoids, or barbiturates
- Past 30-day use of certain pain medications
- Evidence of past 7-day nonmedical drug use
- Known hypersensitvity, allergy to, or history of adverse reactions to study medications
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 |
|---|---|---|
| Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)Within-subject double-blind, double-dummy, study design wherein all participants received all drug combinations (Placebo + Placebo, Hydromorphone + Placebo, Low Dose Gabapentin + Placebo, High Dose Gabapentin + Placebo, Low Dose Gabapentin + Hydromorphone, High Dose Gabapentin + Hydromorphone) in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | Drug | Active hydromorphone, High dose gabapentin, Active hydromorphone, Low dose gabapentin, Active hydromorphone, placebo gabapentin, Placebo hydromorphone, High dose gabapentin, Placebo hydromorphone, Low dose gabapentin, Placebo hydromorphone, Placebo gabapentin |
Primary outcome
Peak change from baseline Drug Effect
Time frame: 8 hour study sessions
Peak self-reported "Drug Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Drug Effect" on a visual anaogue scale (0-100)
Peak change from baseline Good Effect
Time frame: Baseline (0.5 hours before drug administration) and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 8 hours after drug administration
Peak self-reported "Good Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Good Effect" on a visual anaogue scale (0-100), where lower scores indicate no effect and greater scores indicate maximum effect.
Peak Cold Pressor Test Tolerance change from baseline score
Time frame: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Cold Pressor Test Tolerance Score minus baseline Peak Cold Pressor Test Tolerance score. Outcome ranges from 0-60 seconds, 0 indicating low analgesic effect and 60 indicating high analgesic effects.
Peak Cold Pressor Test Threshold change from baseline score
Time frame: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Cold Pressor Test Threshold Score minus baseline Peak Cold Pressor Test Threshold score. Outcome ranges from 0-60 seconds, 0 indicating low analgesic effect and 60 indicating high analgesic effects.
Peak Heat Pain with Capsaicin Threshold change from baseline score
Time frame: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Heat Pain with Capsaicin Threshold score minus baseline Peak Heat Pain with Capsaicin Threshold score. Outcome ranges from 0-100, 0 indicating no pain and 100 indicating extreme pain.
Peak Heat Pain with Capsaicin Tolerance Change from Baseline Score
Time frame: Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration
Peak Heat Pain with Capsaicin Tolerance score minus baseline Peak Heat Pain with Capsaicin Tolerance score. Outcome ranges from 0-100, 0 indicating no pain and 100 indicating extreme pain.
Peak change from baseline Bad Effect
Time frame: Baseline (0.5 hours before drug administration) and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 8 hours after drug administration
Peak self-reported "Bad Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Bad Effect" on a visual anaogue scale (0-100) where lower scores indicate no effect and greater scores indicate maximum effect.
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 29 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Chronic Lower Back Pain (CLBP), run by University of Maryland, Baltimore 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 11 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: opening soon, as of the sponsor's last update on 29 Sep 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Sarah Dowell (667-351-5088, sdowell@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak change from baseline Drug Effect (time frame: 8 hour study sessions). The study lists 7 primary outcomes in all. 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 29 Sep 2026.