Extended-release Naltrexone for Alcohol Dependence in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Marc Gourevitch, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00620750
First received: February 11, 2008
Last updated: August 22, 2011
Last verified: August 2011
Results First Received: June 9, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alcohol Dependence
Intervention: Drug: Extended release injectable naltrexone (Vivitrol)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Extended Release Injectable Naltrexone  
STARTED     65  
COMPLETED     40  
NOT COMPLETED     25  
Lost to Follow-up                 25  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Extended Release Injectable Naltrexone  
Number of Participants  
[units: participants]
  65  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     65  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  46  ± 8.535196  
Gender  
[units: participants]
 
Female     16  
Male     49  
Region of Enrollment  
[units: participants]
 
United States     65  



  Outcome Measures

1.  Primary:   Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections   [ Time Frame: 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marc Gourevitch, MD, MPH
Organization: New York University School of Medicine
phone: 212-263-8553
e-mail: marc.gourevitch@nyumc.org


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Marc Gourevitch, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00620750     History of Changes
Other Study ID Numbers: C18816/6067/DP/US
Study First Received: February 11, 2008
Results First Received: June 9, 2011
Last Updated: August 22, 2011
Health Authority: United States: Institutional Review Board