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| ID | Type | Description | Link |
|---|---|---|---|
| UH2AA026193 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose naltrexone | Experimental | Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks. |
|
| Nalmefene | Experimental | Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose naltrexone | Drug | 4.5 mg of low dose naltrexone taken once daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Primary endpoint at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 8 weeks |
| Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey H. Samet, MD, MA, MPH | Boston University/Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First St. Petersburg Pavlov State Medical University | Saint Petersburg | 197022 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33682527 | Derived | 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. |
| Label | URL |
|---|---|
| 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. | View source |
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All data from the study will be placed into the URBAN ARCH repository.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose Naltrexone | Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks. Low dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks |
| FG001 | Nalmefene | Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks. Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose Naltrexone | Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks. Low dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks |
| BG001 | Nalmefene |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Primary endpoint at 8 weeks |
|
Adverse event data were collected over the course of the 8-week treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose Naltrexone | Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks. Low dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Body injury during fight | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Samet | Boston Medical Center | 617-414-7444 | jsamet@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2018 | Jul 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000428 | Alcohol Drinking |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| C038981 | nalmefene |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Nalmefene | Drug | 18 mg of nalmefene taken once daily for 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. |
| 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. | 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. | 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. | 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. | 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. | Endpoint at 8 weeks |
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education (9 grades or more) | Count of Participants | Participants |
|
| Married/Living with partner/In long-term relationship | Count of Participants | Participants |
|
| At risk drinking based on NIAAA criteria | At risk drinking defined as >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. | Count of Participants | Participants |
|
| Lifetime opioid use | Count of Participants | Participants |
|
| Past 30 day opioid use | Count of Participants | Participants |
|
| Pain severity | Scale of 1-10 with higher numbers indicating greater levels of pain | Median | Inter-Quartile Range | units on a scale |
|
| Pain interference | Scale of 1-10 with higher numbers indicating greater levels of pain | Median | Inter-Quartile Range | units on a scale |
|
| Cold pain threshold | Measured as number of seconds to the initial perception of pain during cold-pressor test | Median | Inter-Quartile Range | seconds |
|
| Cold pain tolerance | Measured as seconds until withdrawal of hand during cold-pressor test | Median | Inter-Quartile Range | seconds |
|
Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks.
Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | grams of ethanol | Baseline, 8 weeks |
|
|
|
| Secondary | 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. | Posted | Number | treatment discontinuations | 4 weeks, 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Endpoint at 8 weeks |
|
|
|
| Secondary | 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. | Posted | Number | participants | Endpoint at 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | number of side effects | 2 weeks, 4 weeks, 6 weeks, 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks, 8 weeks |
|
|
|
| Secondary | 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. | Posted | Number | participants | Endpoint at 8 weeks |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 3 |
| 8 |
| EG001 | Nalmefene | Participants randomized to this group will receive nalmefene (18 mg) for 8 weeks. Nalmefene: 18 mg of nalmefene taken once daily for 8 weeks | 0 | 3 | 0 | 3 | 3 | 3 |
| Irritability | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Weakness | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Abnormal dreams/nightmares | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Sleep problems | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Loss of appetite | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| 6-Weeks |
|
| 8-Weeks |
|