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Extended-release Naltrexone for Alcohol Dependence in Primary Care

NCT ID: NCT00620750

Last Updated: 2011-09-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Extended release injectable naltrexone

Group Type EXPERIMENTAL

Extended release injectable naltrexone (Vivitrol)

Intervention Type DRUG

Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.

Interventions

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Extended release injectable naltrexone (Vivitrol)

Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.

Intervention Type DRUG

Other Intervention Names

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Vivitrol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alkermes, Inc.

INDUSTRY

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Marc Gourevitch

Director of General Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc N Gourevitch, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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NYU School of Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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Lee JD, Grossman E, DiRocco D, Truncali A, Hanley K, Stevens D, Rotrosen J, Gourevitch MN. Extended-release naltrexone for treatment of alcohol dependence in primary care. J Subst Abuse Treat. 2010 Jul;39(1):14-21. doi: 10.1016/j.jsat.2010.03.005. Epub 2010 Apr 2.

Reference Type RESULT
PMID: 20363090 (View on PubMed)

Lee JD, Grossman E, Huben L, Manseau M, McNeely J, Rotrosen J, Stevens D, Gourevitch MN. Extended-release naltrexone plus medical management alcohol treatment in primary care: findings at 15 months. J Subst Abuse Treat. 2012 Dec;43(4):458-62. doi: 10.1016/j.jsat.2012.08.012. Epub 2012 Sep 15.

Reference Type DERIVED
PMID: 22985676 (View on PubMed)

Other Identifiers

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C18816/6067/DP/US

Identifier Type: -

Identifier Source: org_study_id