St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene (PETER PAIN)

Boston Medical Center (BMC)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Alcohol Use

HIV Infection

Pain

Treatments

Drug: Low dose naltrexone

Drug: Nalmefene

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03278886

UH2AA026193 (U.S. NIH Grant/Contract)

H-36491

Details and patient eligibility

About

This study is a randomized controlled trial (RCT) to assess the feasibility, tolerability, and safety of using opioid receptor antagonists (naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol use and chronic pain.

Full description

Pain is a common co-morbidity for HIV-infected patients. Prevalence studies suggest that, on average, half of all HIV-infected persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-infected 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. Opioid receptor antagonists such as naltrexone and nalmefene, which are licensed for treatment of alcohol use disorders, show promise as being effective and safe treatments for chronic pain among persons with HIV. This study will pilot test novel pharmacotherapies (opioid receptor antagonists) to improve chronic pain among HIV-infected heavy drinkers. The specific aims of the research is to assess the feasibility, tolerability and safety of using opioid receptor antagonists (low-dose naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol use and chronic pain.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Uncontrolled psychiatric illness (such as active psychosis) (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the ED or hospital)
History of hypersensitivity to naltrexone, nalmefene, 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
ALT/AST levels >5x normal
History of Raynaud's Disease
Planned surgeries in the next three months
Enrolled in another HIV and/or substance use medication intervention study
Taking naltrexone in the past 30 days
Taking nalmefene in the past 30 days