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
Results First Posted : August 3, 2020
Last Update Posted : August 24, 2020
|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)|
|Actual Enrollment :||11 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|
|Actual Primary Completion Date :||December 19, 2018|
|Actual Study Completion Date :||December 19, 2018|
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.
- 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 [ Time Frame: Baseline, 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: 4 weeks, 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.
- Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence [ 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: 2 weeks, 4 weeks, 6 weeks, 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: 4 weeks, 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. 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 [ Time Frame: Endpoint at 8 weeks ]Aminotransferase levels (AST/ALT) are tested to look for severe hepatotoxicity defined as AST/ALT > 10 times 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
|First St. Petersburg Pavlov State Medical University|
|St. Petersburg, Russian Federation, 197022|
|Principal Investigator:||Jeffrey H. Samet, MD, MA, MPH||Boston University/Boston Medical Center|