Alcohol Dependence
Conditions
Keywords
Alcohol dependence
Brief summary
Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependence into general medical care settings. However, the feasibility of implementing this United States Food and Drug Administration approved treatment in the front-line settings in which it is most needed has not been demonstrated. This is an open-label pilot feasibility study of implementing treatment with Vivitrol in primary care medical clinics in a safety net hospital system affiliated with an urban academic center.
Interventions
DRUGExtended release injectable naltrexone (Vivitrol)
Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.
Sponsors
Alkermes, Inc.
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current alcohol dependence * Age 18 or older * English or Spanish-speaking * Without untreated severe mental illness * Liver enzymes (alanine aminotransferase and aspartate aminotransferase) ≤ 3x normal * Kept 2 of last 3 clinic primary care appointments and/or has a working telephone number at which can be contacted directly * Either a) currently abstinent (e.g., referred from an inpatient 'detox' setting) or b) with the ability, in the clinician's judgment, to achieve and maintain abstinence * If female of child-bearing potential, must be using adequate contraception * Able to understand study procedures
Exclusion criteria
* Currently opioid dependent or requiring ongoing treatment with opioids for any indication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections | 4 months |
Countries
United States
Participant flow
Recruitment details
The study began July 2007. Community recruitment was performed from August 2007 to September 2008 in the primary care clinics of Bellevue Hospital and Gouverneur Diagnostic and Treatment Centers, two public hospital facilities in lower Manhattan. 116 persons contacted study staff regarding possible participation, and 76 were consented and screened.
Pre-assignment details
Four consented patients were ineligible due to elevated liver function tests (n = 2), opioid dependence (n =1), and an uncontrolled psychiatric condition (n = 1). Seventy two participants met eligibility criteria and consented to study involvement, sixty-five participants presented for the initial treatment visit.
Participants by arm
| Arm | Count |
|---|---|
| Extended Release Injectable Naltrexone This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care. | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 25 |
Baseline characteristics
| Characteristic | Extended Release Injectable Naltrexone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants |
| Age Continuous | 46 years STANDARD_DEVIATION 8.535196 |
| Region of Enrollment United States | 65 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 65 |
| serious Total, serious adverse events | 2 / 65 |
Outcome results
Primary
Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections
Time frame: 4 months
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Release Injectable Naltrexone | Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections | 40 Percent of participants |