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
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection Alcohol Use Pain||Drug: Low dose naltrexone Drug: Nalmefene||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
18 mg of nalmefene taken once daily for 8 weeks
- 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.
- 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
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
|Contact: Jeffrey H. Samet, MD, MA, MPHemail@example.com|
|Contact: Judith I. Tsui, MD, MPHfirstname.lastname@example.org|
|First St. Petersburg Pavlov State Medical University||Recruiting|
|St. Petersburg, Russian Federation, 197022|
|Contact: Evgeny Krupitsky, MD,PhD,DMdSc +7-812-365-2217 email@example.com|
|Principal Investigator:||Jeffrey H. Samet, MD, MA, MPH||Boston University/Boston Medical Center|