NCT00620750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 27, 2011

Completed
Last Updated

September 27, 2011

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

February 11, 2008

Results QC Date

June 9, 2011

Last Update Submit

August 22, 2011

Conditions

Alcohol Dependence

Keywords

Alcohol dependence

Outcome Measures

Primary Outcomes (1)

  • Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections

    4 months

Study Arms (1)

Extended release injectable naltrexone

EXPERIMENTAL
Drug: Extended release injectable naltrexone (Vivitrol)

Interventions

Extended release injectable naltrexone (Vivitrol)DRUG

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

Also known as: Vivitrol
Extended release injectable naltrexone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Currently opioid dependent or requiring ongoing treatment with opioids for any indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

Related Publications (2)

  • 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.

    PMID: 20363090RESULT

  • 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.

    PMID: 22985676DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

vivitrol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Limitations and Caveats

There was no formal control arm. Drinking and satisfaction outcomes were self-reported, these outcomes and Adverse Event data were not available for those lost to follow-up. The drinking Timeline Follow-Back is subject to recall and response biases.

Results Point of Contact

Title
Marc Gourevitch, MD, MPH
Organization
New York University School of Medicine
marc.gourevitch@nyumc.org
212-263-8553

Study Officials

  • Marc N Gourevitch, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of General Internal Medicine

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 21, 2008

Study Start

July 1, 2007

Primary Completion

November 1, 2008

Study Completion

February 1, 2010

Last Updated

September 27, 2011

Results First Posted

September 27, 2011

Record last verified: 2011-08

Locations

US(1)