Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | May 2013 |
| End Date: | January 2016 |
Pharmacotherapeutic Intervention to Improve Treatment Engagement Among Alcohol-dependent Veterans After Hospital Discharge
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.
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.
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.
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.
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
We found this trial at
1
site
Madison, Wisconsin 53715
Principal Investigator: Randall T Brown, MD PhD
Phone: 608-265-8926
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