Chronic PainPhase 2UH3NCT04052139
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
A Phase 2 study testing Low-dose naltrexone and Gabapentin in people with Chronic Pain and Alcohol Use, Unspecified, run by Boston Medical Center at 1 site in Russia.
Trial summary
This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin versus placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain; 2) inflammation; and 3) measures of HIV control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Alcohol Use, Unspecified, HIV Infections
- What is being tested?
- Low-dose naltrexone and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteRussia
- Study dates
- 25 Jan 2021to 15 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- HIV-positive
- Chronic pain (present ≥3 mo) of moderate to severe intensity
- Heavy drinking past year (Based on NIAAA criteria: > 14 standard drinks per week/ > 4 drinks in a day for men; > 7 drinks in the past week/ > 3 drinks in a day for women)
- If female, negative pregnancy test and willing to use adequate birth control
- Provision of contact information for 2 contacts to assist with follow-up
Show all 9Show fewer
- Stable address within 100 kilometers of St. Petersburg
- Possession of a telephone (home or cell)
- Able and willing to comply with all study protocols and procedures
Who cannot join
- Not fluent in Russian
- Cognitive impairment resulting in inability to provide informed consent based on research assessor (RA) assessment
- Known active TB or current febrile illness
- Breastfeeding
- Known uncontrolled psychiatric illness (such as active psychosis)
- Current suicidal ideation
Show all 21Show fewer
- History of hypersensitivity to naltrexone, gabapentin, or naloxone
- Current use (past week) of illicit or prescribed opiates as documented by either self-report or positive urine drug test
- Unwilling to abstain from opiates during the treatment period
- Current use of neuroleptics
- History of seizure disorder
- Known liver failure
- AST/ALT levels >5x normal
- CrCl< 60mL/min
- History of Reynaud's disease
- Planned surgeries in the next 3 months
- Enrolled in another HIV and/or substance use medication intervention study
- Taking naltrexone in the past 30 days
- Taking gabapentin in the past 30 days
- Taking pregabalin in the past 30 days
- Diagnosis of chronic obstructive pulmonary disease (COPD)
Trial locations and contacts
1 site in 1 country.
Russia1 site
First St. Petersburg Pavlov State Medical University
Saint Petersburg
About this study
Official title: Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin versus placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain; 2) inflammation; and 3) measures of HIV control. Participants will be followed for 12 weeks. Assessments of study outcomes will be compared at week 8 (end of treatment phase).
Read the detailed description
Pain is a common co-morbidity for HIV-positive patients.Prevalence studies suggest that, on average, half of all HIV-positive persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-positive persons, which may in turn be a barrier to treatment/control of HIV and contribute to spread of HIV. Thus there is an urgent need to address pain among persons with HIV. It is timely and relevant to conduct research on gabapentin, as it has emerged as one of the most commonly prescribed non-opioid medications for pain despite the fact that gabapentin is only FDA approved for "post-herpetic neuralgia" and the literature to support its use for generalized chronic pain is limited. And yet, gabapentin has demonstrated benefits for treatment of alcohol use disorder, and therefore, like naltrexone, it could have a specific role for treating patients with chronic pain and unhealthy alcohol use. This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin vs. placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain (both self-reported and experimental/cold pressor test; 2) inflammation (i.e., levels of inflammatory cytokines IL-6, IL-1β, IL-10, and TNF-α); and 3) measures of HIV control (CD4 count and viral load).
- Conditions
- Chronic Pain, Alcohol Use, Unspecified, HIV Infections
- Being tested
- Low-dose naltrexone, Gabapentin, Placebo
- Keywords
- Pain, Alcohol, HIV, Inflammation, Low-dose naltrexone, Gabapentin
- Medical subject headings
- Chronic Pain, Alcohol Drinking, HIV Infections, Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose naltrexoneDrug
4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
GabapentinDrug
Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
PlaceboDrug
In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose naltrexone | Active comparator | Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks. Receives: Drug: Low-dose naltrexone |
| Gabapentin | Active comparator | Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Participants will receive a placebo to be taken three times daily for 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Past Week Pain Severity
Change in past week pain severity (score 0 [no pain] -10 [high pain]) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
Measured: Baseline, 8-weeks
Change in Past Week Pain Interference
Change in past week pain interference (score 0 [no pain]-10 [high pain]) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
Measured: Baseline, 8-weeks
Secondary outcomes (8)
Change in Cold Pain Tolerance
Mean change in the number of seconds a participant can keep their hand submerged in a container of iced water. Participants were instructed to keep their hand in as long as they could, up to 3 minutes.
Measured: Baseline, 8-weeks
Change in Percentage of Past Month Heavy Drinking Days
Mean percentage of change in self-reported heavy drinking in the past 30 days of alcohol consumption obtained via the Timeline Followback (TLFB) method. The NIAAA definition of heavy drinking is used (> 4 drinks in a day for men; > 3 drinks in a day for women). Participants were asked about their alcohol consumption on each day in the previous 30 days.
Measured: Baseline, 8-weeks
Change in CD4 Count
Defined as mean change in CD4 values from lab assay
Measured: Baseline, 8-weeks
Number of Participants With a Change in HIV Viral Load Suppression Status
Defined as number of participants who change from suppressed to unsuppressed or unsuppressed to suppressed from lab tests
Measured: Baseline, 8-weeks
Change in Biomarker IL-6
Mean change in IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Measured: Baseline, 8-weeks
Change in Biomarker IL-10
Mean change in IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Measured: Baseline, 8 weeks
Change in TNF-alpha
Mean change in TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Measured: Baseline, 8-weeks
Change in IL-1beta
Mean change in IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
Measured: Baseline, 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start25 Jan 2021
- Primary completion16 Nov 2021
- Study completion15 Dec 2021
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 Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Jeffrey H. Samet, MD, MA, MPH, Principal investigator, Boston University/Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052139
- Sponsor's protocol ID
- H-39162
- Other IDs
- UH3AA026193
- Acronym
- UH3
- Status last verified
- Oct 2022
- First submitted
- 8 Aug 2019
- Last updated
- 10 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data from the study will be placed into the URBAN ARCH repository.
Publications
Tsui JI, Rossi SL, Cheng DM, Bendiks S, Vetrova M, Blokhina E, Winter M, Gnatienko N, Backonja M, Bryant K, Krupitsky E, Samet JH. Pilot RCT comparing low-dose naltrexone, gabapentin and placebo to reduce pain among people with HIV with alcohol problems. PLoS One. 2024 Feb 26;19(2):e0297948. doi: 10.1371/journal.pone.0297948. eCollection 2024.
PubMed 38408060
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
- ClinicalTrials.gov ID
- NCT04052139
- Acronym / sponsor ID
- UH3 / H-39162
- Conditions
- Chronic Pain, Alcohol Use, Unspecified, HIV Infections
- Keywords
- Pain, Alcohol, HIV, Inflammation, Low-dose naltrexone, Gabapentin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Posted 10 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin versus placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain; 2) inflammation; and 3) measures of HIV control. Participants will be followed for 12 weeks. Assessments of study outcomes will be compared at week 8 (end of treatment phase).
Detailed description
Pain is a common co-morbidity for HIV-positive patients.Prevalence studies suggest that, on average, half of all HIV-positive persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-positive persons, which may in turn be a barrier to treatment/control of HIV and contribute to spread of HIV. Thus there is an urgent need to address pain among persons with HIV. It is timely and relevant to conduct research on gabapentin, as it has emerged as one of the most commonly prescribed non-opioid medications for pain despite the fact that gabapentin is only FDA approved for "post-herpetic neuralgia" and the literature to support its use for generalized chronic pain is limited. And yet, gabapentin has demonstrated benefits for treatment of alcohol use disorder, and therefore, like naltrexone, it could have a specific role for treating patients with chronic pain and unhealthy alcohol use. This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin vs. placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain (both self-reported and experimental/cold pressor test; 2) inflammation (i.e., levels of inflammatory cytokines IL-6, IL-1β, IL-10, and TNF-α); and 3) measures of HIV control (CD4 count and viral load).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose naltrexone | Active comparator | Drug: Low-dose naltrexoneParticipants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks. |
| Gabapentin | Active comparator | Drug: GabapentinParticipants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a placebo to be taken three times daily for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- HIV-positive
- Chronic pain (present ≥3 mo) of moderate to severe intensity
- Heavy drinking past year (Based on NIAAA criteria: > 14 standard drinks per week/ > 4 drinks in a day for men; > 7 drinks in the past week/ > 3 drinks in a day for women)
- If female, negative pregnancy test and willing to use adequate birth control
Key exclusion criteria (21 listed)
- Not fluent in Russian
- Cognitive impairment resulting in inability to provide informed consent based on research assessor (RA) assessment
- Known active TB or current febrile illness
- Breastfeeding
- Known uncontrolled psychiatric illness (such as active psychosis)
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 |
|---|---|---|
| Low-dose naltrexone4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily. | Drug | Low-dose naltrexone |
| GabapentinDose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). | Drug | Gabapentin |
| PlaceboIn week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients. | Drug | Placebo |
Primary outcome
Change in Past Week Pain Severity
Time frame: Baseline, 8-weeks
Change in past week pain severity (score 0 [no pain] -10 [high pain]) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
Change in Past Week Pain Interference
Time frame: Baseline, 8-weeks
Change in past week pain interference (score 0 [no pain]-10 [high pain]) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function
8 secondary outcomes
Change in Cold Pain Tolerance
Time frame: Baseline, 8-weeks
Change in Percentage of Past Month Heavy Drinking Days
Time frame: Baseline, 8-weeks
Change in CD4 Count
Time frame: Baseline, 8-weeks
Number of Participants With a Change in HIV Viral Load Suppression Status
Time frame: Baseline, 8-weeks
Change in Biomarker IL-6
Time frame: Baseline, 8-weeks
Change in Biomarker IL-10
Time frame: Baseline, 8 weeks
Change in TNF-alpha
Time frame: Baseline, 8-weeks
Change in IL-1beta
Time frame: Baseline, 8-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38408060Tsui JI, Rossi SL, Cheng DM, Bendiks S, Vetrova M, Blokhina E, Winter M, Gnatienko N, Backonja M, Bryant K, Krupitsky E, Samet JH. Pilot RCT comparing low-dose naltrexone, gabapentin and placebo to reduce pain among people with HIV with alcohol problems. PLoS One. 2024 Feb 26;19(2):e0297948. doi: 10.1371/journal.pone.0297948. eCollection 2024.
- URBAN ARCH, a member of NIAAA CHAART (Consortiums for HIV/AIDS \& Alcohol Research Translation) initiative, conducts and disseminates interdisciplinary research on how alcohol impacts people with HIV and develops interventions to reduce related outcomes.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data from the study will be placed into the URBAN ARCH repository.
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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.
Jeffrey H. Samet, MD, MA, MPH principal investigator
Boston University/Boston Medical Center
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 Low-dose naltrexone and Gabapentin in people with Chronic Pain and Alcohol Use, Unspecified, run by Boston Medical Center at 1 site in Russia.
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 9 inclusion and 21 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 10 Nov 2022. 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 Russia. 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 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 10 Nov 2022). 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?
Change in Past Week Pain Severity (time frame: Baseline, 8-weeks). The study lists 2 primary outcomes in all. 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 NCT04052139, 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 10 Nov 2022.