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

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ClinicalTrials.gov Identifier: NCT03278886
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infection Alcohol Use Pain Drug: Low dose naltrexone Drug: Nalmefene Phase 1 Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Low dose naltrexone
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Drug: Low dose naltrexone
4.5 mg of low dose naltrexone taken once daily for 8 weeks

Experimental: Nalmefene
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Drug: Nalmefene
18 mg of nalmefene taken once daily for 8 weeks




Primary Outcome Measures :
  1. Medication tolerability measured via a 0-100 visual analog scale [ Time Frame: Primary endpoint at 8 weeks ]
    Medication tolerability will be measured via a 0-100 visual analog scale. Participants will be asked to indicate on a scale of 0-100, how well they have tolerated the study medication with 0 anchored as "cannot tolerate at all" and 100 as "tolerate perfectly well." Higher numbers will be indicative of higher tolerability of the medication.


Secondary Outcome Measures :
  1. Alcohol reduction [ Time Frame: Endpoint at 8 weeks ]
    Measured as a reduction in mean number of grams of pure ethanol consumed per day

  2. Treatment discontinuation [ Time Frame: Endpoint at 8 weeks ]
    Defined as patient self-report of stopping medication anytime during the treatment period

  3. Adherence (self-report) [ Time Frame: Endpoint at 8 weeks ]
    Defined as self-report of the percentage of study medications taken by drawing a line on a a visual analog scale from 0 to 100. Higher numbers will indicate higher adherence to study medication.

  4. Adherence (riboflavin) [ Time Frame: Endpoint at 8 weeks ]
    Measured through examination of urine for presence of color change due to riboflavin

  5. Side effects [ Time Frame: Endpoint at 8 weeks ]
    Using a Symptom Checklist, plus an open-ended question

  6. Medication satisfaction [ Time Frame: Endpoint at 8 weeks ]
    Using a 14-item questionnaire

  7. Severe hepatotoxicity [ Time Frame: Endpoint at 8 weeks ]
    Defined as AST/ALT >10X the level of normal



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278886


Contacts
Contact: Jeffrey H. Samet, MD, MA, MPH 617-414-7288 jsamet@bu.edu
Contact: Judith I. Tsui, MD, MPH 206-744-1835 tsuij@uw.edu

Locations
Russian Federation
First St. Petersburg Pavlov State Medical University Recruiting
St. Petersburg, Russian Federation, 197022
Contact: Evgeny Krupitsky, MD,PhD,DMdSc    +7-812-365-2217    kruenator@gmail.com   
Sponsors and Collaborators
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Jeffrey H. Samet, MD, MA, MPH Boston University/Boston Medical Center

Additional Information:
Responsible Party: Jeffrey Samet, Chief, Section of General and Internal Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT03278886     History of Changes
Other Study ID Numbers: H-36491
UH2AA026193 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data from the study will be placed into the URBAN ARCH repository.
URL: http://www.urbanarch.org

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeffrey Samet, Boston Medical Center:
Alcohol Use
Pain
HIV
Low-dose naltrexone
Nalmefene

Additional relevant MeSH terms:
HIV Infections
Alcohol Drinking
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Drinking Behavior
Ethanol
Naltrexone
Nalmefene
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents