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

Primary Purpose

HIV Infection, Alcohol Use, Pain

Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Low dose naltrexone
Nalmefene
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring Alcohol Use, Pain, HIV, Low-dose naltrexone, Nalmefene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • First St. Petersburg Pavlov State Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low dose naltrexone

Nalmefene

Arm Description

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

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

Outcomes

Primary Outcome Measures

Medication Tolerability Measured Via a 0-100 Visual Analog Scale
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

Change in Alcohol Use Defined as a Change in the Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 Weeks
Measured via 30 Day Alcohol Use Timeline Follow Back Method
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period
Measured via one question asking participants if they had discontinued medication since their last visit. Assessed at 4 and 8 week study visits.
Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks
Measured by participants' drawing a line on a a Visual Analog Scale, which ranges from 0 to 100. Higher numbers indicate higher adherence to study medication.
Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence
Measured through visual inspection of the urine for the presence or absence of riboflavin using ultraviolet (UV) light at the long wave setting (33 mm) in a room with low ambient light.
Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question
Measured via a 16-item symptom checklist with the option for participants to report any experienced side effects not on the checklist. Side effect severity is rated by trained research assessors. The checklist is asked at 2, 4, 6, and 8-week study visits.
Medication Satisfaction Defined as a Score From 0-100 Measured Via the Treatment Satisfaction Questionnaire for Medication (TSQM), With Higher Scores Corresponding to Higher Treatment Satisfaction.
Measured via using the 14-item Treatment Satisfaction Questionnaire, which consists of 14 items that result in four domains: Effectiveness, Side Effects, Convenience and Global Satisfaction. Higher scores indicate greater satisfaction with medication. Assessed at 4 and 8 week study visits.
Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal
Aminotransferase levels (AST/ALT) are tested to look for severe hepatotoxicity defined as AST/ALT > 10 times the level of normal.

Full Information

First Posted
September 5, 2017
Last Updated
August 7, 2020
Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03278886
Brief Title
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene
Acronym
PETER PAIN
Official Title
Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
December 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Alcohol Use, Pain
Keywords
Alcohol Use, Pain, HIV, Low-dose naltrexone, Nalmefene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose naltrexone
Arm Type
Experimental
Arm Description
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Arm Title
Nalmefene
Arm Type
Experimental
Arm Description
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Low dose naltrexone
Intervention Description
4.5 mg of low dose naltrexone taken once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Nalmefene
Intervention Description
18 mg of nalmefene taken once daily for 8 weeks
Primary Outcome Measure Information:
Title
Medication Tolerability Measured Via a 0-100 Visual Analog Scale
Description
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.
Time Frame
Primary endpoint at 8 weeks
Secondary Outcome Measure Information:
Title
Change in Alcohol Use Defined as a Change in the Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 Weeks
Description
Measured via 30 Day Alcohol Use Timeline Follow Back Method
Time Frame
Baseline, 8 weeks
Title
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period
Description
Measured via one question asking participants if they had discontinued medication since their last visit. Assessed at 4 and 8 week study visits.
Time Frame
4 weeks, 8 weeks
Title
Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks
Description
Measured by participants' drawing a line on a a Visual Analog Scale, which ranges from 0 to 100. Higher numbers indicate higher adherence to study medication.
Time Frame
Endpoint at 8 weeks
Title
Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence
Description
Measured through visual inspection of the urine for the presence or absence of riboflavin using ultraviolet (UV) light at the long wave setting (33 mm) in a room with low ambient light.
Time Frame
Endpoint at 8 weeks
Title
Reported Side Effects Using a Symptom Checklist, Plus an Open-ended Question
Description
Measured via a 16-item symptom checklist with the option for participants to report any experienced side effects not on the checklist. Side effect severity is rated by trained research assessors. The checklist is asked at 2, 4, 6, and 8-week study visits.
Time Frame
2 weeks, 4 weeks, 6 weeks, 8 weeks
Title
Medication Satisfaction Defined as a Score From 0-100 Measured Via the Treatment Satisfaction Questionnaire for Medication (TSQM), With Higher Scores Corresponding to Higher Treatment Satisfaction.
Description
Measured via using the 14-item Treatment Satisfaction Questionnaire, which consists of 14 items that result in four domains: Effectiveness, Side Effects, Convenience and Global Satisfaction. Higher scores indicate greater satisfaction with medication. Assessed at 4 and 8 week study visits.
Time Frame
4 weeks, 8 weeks
Title
Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal
Description
Aminotransferase levels (AST/ALT) are tested to look for severe hepatotoxicity defined as AST/ALT > 10 times the level of normal.
Time Frame
Endpoint at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey H. Samet, MD, MA, MPH
Organizational Affiliation
Boston University/Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
First St. Petersburg Pavlov State Medical University
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data from the study will be placed into the URBAN ARCH repository.
IPD Sharing URL
http://www.urbanarch.org
Citations:
PubMed Identifier
33682527
Citation
Bendiks S, Cheng DM, Blokhina E, Vetrova M, Verbitskaya E, Gnatienko N, Bryant K, Krupitsky E, Samet JH, Tsui JI. Pilot study of tolerability and safety of opioid receptor antagonists as novel therapies for chronic pain among persons living with HIV with past year heavy drinking: a randomized controlled trial. AIDS Care. 2023 Aug;35(8):1191-1200. doi: 10.1080/09540121.2021.1896663. Epub 2021 Mar 7.
Results Reference
derived
Links:
URL
http://www.urbanarch.org
Description
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.

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St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

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