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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278886
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE July 3, 2018
Actual Primary Completion Date December 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
  • Alcohol reduction defined as a decrease in mean number of grams of pure ethanol consumed per day from baseline to 8 weeks [ Time Frame: Endpoint at 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 [ Time Frame: Endpoint at 8 weeks ]
    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 [ Time Frame: Endpoint at 8 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.
  • Adherence assessed via riboflavin in the urine [ Time Frame: Endpoint at 8 weeks ]
    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 [ Time Frame: Endpoint at 8 weeks ]
    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. [ Time Frame: Endpoint at 8 weeks ]
    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. Assessed at 4 and 8 week study visits.
  • Severe hepatotoxicity defined as AST/ALT >10X the level of normal [ Time Frame: Endpoint at 8 weeks ]
    Aminotransferase levels (AST/ALT) are tested at 4 and 8 weeks to look for severe hepatotoxicity defined as AST/ALT > 10 times the level of normal.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • Alcohol reduction [ Time Frame: Endpoint at 8 weeks ]
    Measured as a reduction in mean number of grams of pure ethanol consumed per day
  • Treatment discontinuation [ Time Frame: Endpoint at 8 weeks ]
    Defined as patient self-report of stopping medication anytime during the treatment period
  • 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.
  • Adherence (riboflavin) [ Time Frame: Endpoint at 8 weeks ]
    Measured through examination of urine for presence of color change due to riboflavin
  • Side effects [ Time Frame: Endpoint at 8 weeks ]
    Using a Symptom Checklist, plus an open-ended question
  • Medication satisfaction [ Time Frame: Endpoint at 8 weeks ]
    Using a 14-item questionnaire
  • Severe hepatotoxicity [ Time Frame: Endpoint at 8 weeks ]
    Defined as AST/ALT >10X the level of normal
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene
Official Title  ICMJE Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infection
  • Alcohol Use
  • Pain
Intervention  ICMJE
  • Drug: Low dose naltrexone
    4.5 mg of low dose naltrexone taken once daily for 8 weeks
  • Drug: Nalmefene
    18 mg of nalmefene taken once daily for 8 weeks
Study Arms  ICMJE
  • Experimental: Low dose naltrexone
    Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
    Intervention: Drug: Low dose naltrexone
  • Experimental: Nalmefene
    Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
    Intervention: Drug: Nalmefene
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019)
11
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
16
Actual Study Completion Date  ICMJE December 19, 2018
Actual Primary Completion Date December 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278886
Other Study ID Numbers  ICMJE H-36491
UH2AA026193 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Jeffrey Samet, Boston Medical Center
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Jeffrey H. Samet, MD, MA, MPH Boston University/Boston Medical Center
PRS Account Boston Medical Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP