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Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01856712
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The over-arching goal of the proposed project is to understand the impact of medication adherence upon engagement in behavioral treatment for alcohol use disorders. The proposed project is a pilot feasibility study of inpatient veterans with problem alcohol use at the William S. Middleton VA Hospital (Madison, WI). Participants will be randomized to one of two parallel study conditions: (1) an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone, or (2) a single 380 mg intramuscular injection of naltrexone administered prior to discharge and a second injection one month later. The central hypothesis is that hospital-administered injectable naltrexone, when compared to daily oral naltrexone taken at home, will reduce alcohol use in the days immediately following hospitalization. Injectable naltrexone has been efficacious vs. placebo in addition to behavioral treatment in several studies. However, it has yet to be examined in head-to-head comparison with oral naltrexone, or in the hospital setting as an intervention that might facilitate behavioral treatment follow up after discharge.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Naltrexone Phase 3

Detailed Description:

The proposed project is a pilot feasibility study of inpatient veterans with problem alcohol use at the William S. Middleton VA Hospital. The over-arching goal is to understand the impact of medication adherence upon engagement in behavioral treatment for alcohol use disorders. Participants will be randomized to one of two parallel study conditions: (1) an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone, or (2) a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days) administered prior to discharge followed by a second injection one month later. The central hypothesis is that hospital-administered, long-acting injectable naltrexone, when compared to daily oral naltrexone, will reduce alcohol use in the days immediately following hospitalization. This reduced consumption, we hypothesize, will be followed by improved engagement in substance abuse treatment.

Primary Aim: Demonstrate the feasibility of the proposed recruitment methods and study design. This aim comprises two measures with corresponding goals: (1) Recruitment/enrollment—with a recruitment goal of 50 eligible and consenting subjects in an 8 month time period, and (2) Follow-up data collection with a goal of post-hospitalization follow-up data on no less than 70% of enrolled subjects.

Secondary Aims: As a pilot feasibility study, we may not anticipate sufficient power to attain statistical significance on patient-oriented outcome measures. However, it will be important for us to consider and to evaluate pertinent outcomes and potential moderators in order to (1) develop and fine-tune study design, and (2) determine effect sizes for primary outcomes so that we may calculate appropriate sample sizes for future larger study. As such, the secondary aims for the current study are:

  1. To compare injectable naltrexone study to oral naltrexone in terms of attendance to recommended outpatient substance abuse treatment. We hypothesize that injectable naltrexone will be associated with improved likelihood of attending initial visits for substance abuse treatment.
  2. To compare study arms in terms of ongoing alcohol consumption. We hypothesize that (1) improved medication adherence in the oral naltrexone arm and (2) assignment to injectable naltrexone will be associated with reduced alcohol consumption (number of heavy drinking days in the past 14 days) following hospital discharge.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacotherapeutic Intervention to Improve Treatment Engagement Among Alcohol-dependent Veterans After Hospital Discharge
Study Start Date : May 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: oral naltrexone
an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone
Drug: Naltrexone
Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.
Other Name: Revia, Vivitrol

Experimental: injectable naltrexone
a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later.
Drug: Naltrexone
Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.
Other Name: Revia, Vivitrol




Primary Outcome Measures :
  1. Retention Rate: Percentage of Participants Attended an Initial Behavioral Treatment Visit Within 2 Weeks of Hospital Discharge. [ Time Frame: 12 months ]
    Retention rate was measured in terms of percentage of participants attended an initial behavioral treatment visit within 2 weeks of hospital discharge.


Secondary Outcome Measures :
  1. Percentage of Patients Attended Recommended Outpatient Substance Abuse Treatment [ Time Frame: 12 months ]
    Attendance to recommended outpatient substance abuse treatment will be compared between injectable naltrexone group and oral naltrexone group. Keeping patients engaged in treatment is desirable and is known to improve addiction-related outcomes.

  2. Percentage of Participants Adhered to Medication [ Time Frame: 12 months ]
    Medication adherence was measured as percentage of participants who took ≥ 80% of daily naltrexone doses determined via pill counts. Adherence of daily medication will predict treatment engagement following hospital discharge.

  3. Ongoing Alcohol Consumption [ Time Frame: 12 months ]
    To compare study arms in terms of ongoing alcohol consumption. We hypothesize that (1) improved medication adherence in the oral naltrexone arm and (2) assignment to injectable naltrexone will be associated with reduced alcohol consumption (number of heavy drinking days in the past 14 days) following hospital discharge.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • diagnostic criteria for alcohol dependence or abuse
  • women of childbearing potential who have a negative screening urine pregnancy test and are willing to use reliable birth control methods throughout the duration of the study

Exclusion Criteria:

  • active or recently active (less than 1 year) opioid dependence or daily use of opioid analgesics
  • acute hepatitis or liver failure
  • pregnancy
  • women who are currently breastfeeding
  • active suicidality
  • inability to provide written informed consent as determined by study comprehension questions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856712


Locations
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United States, Wisconsin
University of Wisconsin - Department of Family Medicine
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Randall T Brown, MD PhD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01856712    
Other Study ID Numbers: 2012-0702
First Posted: May 17, 2013    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019
Keywords provided by University of Wisconsin, Madison:
alcohol
veterans
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents