Phase 4
Completed N=65
Extended-release Naltrexone for Alcohol Dependence in Primary Care
Source: ClinicalTrials.gov NCT00620750 ↗Enrolled (actual)
65
Serious AEs
3.1%
Results posted
Sep 2011
Primary outcomePrimary: Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections — 40 Percent of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections |
40 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00620750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.