Clinical trial NCT04052139: St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
Official title: Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pain
Alcohol Use, Unspecified
HIV Infections
Keywords: Pain
Alcohol
HIV
Inflammation
Low-dose naltrexone
Gabapentin
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-08-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: Change in Past Week Pain Severity
timeFrame: Baseline, 8-weeks
measure: Change in Past Week Pain Interference
timeFrame: Baseline, 8-weeks
Secondary outcomes:
measure: Change in Cold Pain Tolerance
timeFrame: Baseline, 8-weeks
measure: Change in Percentage of Past Month Heavy Drinking Days
timeFrame: Baseline, 8-weeks
measure: Change in CD4 Count
timeFrame: Baseline, 8-weeks
measure: Number of Participants With a Change in HIV Viral Load Suppression Status
timeFrame: Baseline, 8-weeks
measure: Change in Biomarker IL-6
timeFrame: Baseline, 8-weeks
measure: Change in Biomarker IL-10
timeFrame: Baseline, 8 weeks
measure: Change in TNF-alpha
timeFrame: Baseline, 8-weeks
measure: Change in IL-1beta
timeFrame: Baseline, 8-weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: First St. Petersburg Pavlov State Medical University
Study officials:
affiliation: Boston University/Boston Medical Center
name: Jeffrey H. Samet, MD, MA, MPH
role: PRINCIPAL_INVESTIGATOR
References: