A Phase 1/2 interventional study of Low dose naltrexone and Nalmefene in HIV Infection, Alcohol Use and Pain, sponsored by Boston Medical Center. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-24.
Sponsored by Boston Medical Center · Phase 1/2, Interventional, and Treatment
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 11 is below the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Drug: Low dose naltrexone
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Drug: Nalmefene
4.5 mg of low dose naltrexone taken once daily for 8 weeks
18 mg of nalmefene taken once daily for 8 weeks
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.
Time frame: Primary endpoint at 8 weeks
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
Time frame: Baseline, 8 weeks
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.
Time frame: 4 weeks, 8 weeks
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.
Time frame: Endpoint at 8 weeks
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.
Time frame: Endpoint at 8 weeks
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.
Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks
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.
Time frame: 4 weeks, 8 weeks
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.
Time frame: Endpoint at 8 weeks
| Milestone | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| Started | 8 | 3 |
| Completed | 8 | 2 |
| Not completed | 0 | 1 |
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.
| score on a scale | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| Medication Tolerability Measured Via a 0-100 Visual Analog Scale | 90.7 ± 22.4 | NA ± NA |
Measured via 30 Day Alcohol Use Timeline Follow Back Method
| grams of ethanol | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| 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 | 5.5 ± 10.1 | -6.83 ± 9.7 |
Measured via one question asking participants if they had discontinued medication since their last visit. Assessed at 4 and 8 week study visits.
| treatment discontinuations | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| 4-Weeks | 1 | 1 |
| 8-Weeks | 1 | 2 |
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.
| score on a scale | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two Weeks | 87.5 ± 35.4 | 0 ± 0 |
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.
| participants | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming Adherence | 1 | 0 |
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.
| number of side effects | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| 2-Weeks | 1.5 ± 1.6 | 4.5 ± 6.4 |
| 4-Weeks | 1.3 ± 1.2 | 1.5 ± 2.1 |
| 6-Weeks | 0.9 ± 1.0 | 1.5 ± 2.1 |
| 8-Weeks | 0 ± 0 | 0 ± 0 |
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.
| score on a scale | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| 4-Weeks | 47.3 ± 24.4 | 3.6 ± 5.1 |
| 8-Weeks | 47.3 ± 21.9 | 3.6 ± 5.1 |
Aminotransferase levels (AST/ALT) are tested to look for severe hepatotoxicity defined as AST/ALT \> 10 times the level of normal.
| participants | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| Severe Hepatotoxicity Defined as AST/ALT >10X the Level of Normal | 0 | 0 |
Collected over Adverse event data were collected over the course of the 8-week treatment period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Dose Naltrexone | 0/8 (0%) | 1/8 (12.5%) | 3/8 (37.5%) |
| Nalmefene | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| Body injury during fightInjury, poisoning and procedural complications | 1/8 | 0/3 |
| Event | Low Dose Naltrexone | Nalmefene |
|---|---|---|
| WeaknessGeneral disorders | 0/8 | 2/3 |
| NauseaGastrointestinal disorders | 0/8 | 2/3 |
| DizzinessNervous system disorders | 0/8 | 2/3 |
| AnxietyPsychiatric disorders | 0/8 | 2/3 |
| AgitationGeneral disorders | 0/8 | 1/3 |
| IrritabilityGeneral disorders | 0/8 | 1/3 |
| TremorNervous system disorders | 0/8 | 1/3 |
| Abnormal dreams/nightmaresPsychiatric disorders | 0/8 | 1/3 |
| ConfusionPsychiatric disorders | 0/8 | 1/3 |
| Sleep problemsPsychiatric disorders | 0/8 | 1/3 |
| Age, Continuous(years) | Low Dose Naltrexone | Nalmefene | Total |
|---|---|---|---|
| Mean | 38.3 ± 7.46 | 35.7 ± 1.09 | 37.8 ± 7.02 |
| Sex: Female, Male(Participants) | Low Dose Naltrexone | Nalmefene | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 3 | 2 | 5 |
| Race and Ethnicity Not Collected(Participants) | Low Dose Naltrexone | Nalmefene | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Low Dose Naltrexone | Nalmefene | Total |
|---|---|---|---|
| Russia | 8 | 3 | 11 |
| Education (9 grades or more)(Participants) | Low Dose Naltrexone | Nalmefene | Total |
|---|---|---|---|
| Count of participants | 8 | 3 | 11 |
| Married/Living with partner/In long-term relationship(Participants) | Low Dose Naltrexone | Nalmefene | Total |
|---|---|---|---|
| Count of participants | 5 | 3 | 8 |
| At risk drinking based on NIAAA criteria(Participants) | Low Dose Naltrexone | Nalmefene | Total |
|---|---|---|---|
| Count of participants | 2 | 1 | 3 |
| Lifetime opioid use(Participants) | Low Dose Naltrexone | Nalmefene | Total |
|---|---|---|---|
| Count of participants | 5 | 3 | 8 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All data from the study will be placed into the URBAN ARCH repository.
Data sharing details ↗ · www.urbanarch.org
Ran from Jul 2018 to primary completion in Dec 2018, 5 months.
Results were first posted in Aug 2020, 1 year 7 months after primary completion.
Of 35 non-industry phase 1/2 interventional studies under HIV Infections, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 73. This study's 5 months is below that.
Counting every sponsor, half of 42 studies reached it within 47 months; a quarter within 22 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Naltrexone · Nalmefene