St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-03

Study Completion Date

2018-12-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infection Alcohol Use Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low dose naltrexone

Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.

Group Type EXPERIMENTAL

Low dose naltrexone

Intervention Type DRUG

4.5 mg of low dose naltrexone taken once daily for 8 weeks

Nalmefene

Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.

Group Type EXPERIMENTAL

Nalmefene

Intervention Type DRUG

18 mg of nalmefene taken once daily for 8 weeks

Interventions

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Low dose naltrexone

4.5 mg of low dose naltrexone taken once daily for 8 weeks

Intervention Type DRUG

Nalmefene

18 mg of nalmefene taken once daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No