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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA018923 | 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 is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX) and counseling on highly active antiretroviral treatment (HAART) medication adherence in a cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol abuse and/or dependence, and inadequate (< 95%) HAART adherence. All patients will receive a behavioral intervention, termed Medical Management/Medication Coaching or MM/MC. MM/MC incorporates the behavioral platform Medical Management (MM) from the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded COMBINE Study to reduce heavy alcohol use with Medication Coaching (MC), a manualized treatment designed to improve HAART medication adherence in HIV-infected patients with substance use disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTX + MM/MC | Active Comparator | Naltrexone + Medical Management/Medication Coaching |
|
| Placebo + MM/MC | Placebo Comparator | Placebo plus Medical Management/Medication Coaching |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HAART Adherence | The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Heavy Drinking Days | This outcome is intended to compare the efficacy of NTX +MM/MC versus placebo +MM/MC in reducing days of heavy drinking. It is hypothesized that NTX +MM/MC will lead to greater reductions in the number of days of heavy drinking when compared to placebo + MM/MC. | One year |
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Inclusion Criteria:
Exclusion Criteria:
Be psychotic or severely psychiatrically disabled.
Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
Have medical conditions that would preclude completing or be of harm during the course of the study.
Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times the upper limit of the normal range) or cirrhosis with a Child-Pugh classification greater than A or B.
Have a known contraindication to NTX therapy (e.g. requiring opioid medication for pain).
Be pregnant, nursing or unable to use an effective method of birth control (women).
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| Name | Affiliation | Role |
|---|---|---|
| Lynn E Sullivan (Fiellin), MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States | ||
| VACT Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30073637 | Background | Edelman EJ, Moore BA, Holt SR, Hansen N, Kyriakides TC, Virata M, Brown ST, Justice AC, Bryant KJ, Fiellin DA, Fiellin LE. Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial. AIDS Behav. 2019 Jan;23(1):211-221. doi: 10.1007/s10461-018-2241-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NTX + MM/MC | Naltrexone + Medical Management/Medication Coaching Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals. |
| FG001 | Placebo + MM/MC | Placebo plus Medical Management/Medication Coaching Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + MM/MC | Placebo plus Medical Management/Medication Coaching Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching |
| BG001 | NTX + MM/MC |
| 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 | HAART Adherence | The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC. | data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline. | Posted | Count of Participants | Participants | One year |
|
Adverse events were collected up through the 1 year follow up 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 | Placebo + MM/MC | Placebo plus Medical Management/Medication Coaching Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hallucination | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall Related Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lynn Fiellin | Yale School of Medicine | 203-737-3347 | lynn.fiellin@yale.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 | Oct 11, 2018 | Feb 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| C000624616 | vivitrol |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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|
| Placebo + Medication Management/Medication Coaching | Other | Placebo + Medication Management/Medication Coaching |
|
| New Haven |
| Connecticut |
| 06516 |
| United States |
Naltrexone + Medical Management/Medication Coaching
Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ART Adherence | Presented are the average proportion of days (out of 30) that each participant was ART adherent. | Mean | Standard Deviation | proportion of days adherent |
|
| Undetectable HIV Viral Load | Count of Participants | Participants |
|
| CD4 count | Mean | Standard Deviation | cells/mm3 |
|
| VACS Score | The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV) . The potential range is 0-164. A 5 point increase is associated with 20% increased risk of death. | Mean | Standard Deviation | units on a scale |
|
| Heavy Drinking Days in past 30 Days | Mean | Standard Deviation | days |
|
| ANY Drinking Days in past 30 Days | Mean | Standard Deviation | days |
|
| Alcohol Abuse/Dependence | Count of Participants | Participants |
|
| Drug Abuse/Dependence | Count of Participants | Participants |
|
| Prior Alcohol or Drug Treatment | Count of Participants | Participants |
|
| Prior Receipt for Medications to Help with Drinking | Count of Participants | Participants |
|
Naltrexone + Medical Management/Medication Coaching
Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
|
|
| Secondary | Heavy Drinking Days | This outcome is intended to compare the efficacy of NTX +MM/MC versus placebo +MM/MC in reducing days of heavy drinking. It is hypothesized that NTX +MM/MC will lead to greater reductions in the number of days of heavy drinking when compared to placebo + MM/MC. | data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline. | Posted | Mean | Standard Deviation | days | One year |
|
|
|
| 0 |
| 26 |
| 3 |
| 26 |
| 4 |
| 26 |
| EG001 | NTX + MM/MC | Naltrexone + Medical Management/Medication Coaching Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals. | 0 | 25 | 6 | 25 | 3 | 25 |
| Intoxication | General disorders | Non-systematic Assessment | Hospitalization as a result of relapse or intoxication |
|
| Suicidal Thoughts | Psychiatric disorders | Non-systematic Assessment |
|
| Testicular Inflammation | Reproductive system and breast disorders | Non-systematic Assessment |
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| Seizure | Nervous system disorders | Non-systematic Assessment |
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| Chest Pain | Cardiac disorders | Non-systematic Assessment |
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| Loss of Consciousness | Nervous system disorders | Non-systematic Assessment |
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| Hand Paralysis | Nervous system disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Foot Infection | Infections and infestations | Non-systematic Assessment |
|
| Spinal Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Blood Clot | Hepatobiliary disorders | Non-systematic Assessment |
|
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| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| 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 |
| 24 Weeks |
|
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| 36 Weeks |
|
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| 52 Weeks |
|
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