Monthly Injectable Naltrexone Is Efficacious for Treating Alcohol Dependence
Medications
have moderate efficacy for treating alcohol dependence.
However, adherence is a great challenge in patients with
alcoholism. Researchers tested a new polylactideco-glycolide-based,
long-acting formulation of naltrexone in a multicenter
randomized trial of 624 patients with alcohol dependence
and >=2 heavy drinking episodes* per week in the month
before screening. Subjects were assigned to receive injections
of either naltrexone (380 mg or 190 mg) or placebo every
4 weeks for 6 months. They were also provided with supportive
therapy sessions that included feedback on addiction-related
consequences.
- Nausea, fatigue, decreased
appetite, dizziness, injection site pain, and discontinuation
of injections due to adverse effects were significantly
more common in the higher-dose naltrexone group than
in the placebo group. Results appeared similar for the
lower-dose group. - The rate of heavy drinking
decreased significantly in the higher-dose group and
at a borderline significant level in the lower-dose
group (hazard ratios 0.8 for both compared with placebo). - Subgroup analyses indicated
that
- heavy drinking decreased
only in men; - having abstinence as
a treatment goal did not affect the results, though
naltrexone’s efficacy was greatest in the 8% who had
abstained for 7 days before study entry.
Comments:
This
trial is particularly important among studies of pharmacotherapy
for alcohol dependence. It not only highlights the potential
advantages of a medication that poses fewer challenges
to good adherence, but also did not require patients to
stop drinking to enroll. Injectable naltrexone will likely
become an attractive adjunct to supportive therapy for
people who seek treatment for alcohol dependence.
Richard Saitz, MD, MPH
Reference:
Garbutt
JC, Kranzler HR, O’Malley SS, et al. Efficacy
and tolerability of long-acting injectable naltrexone for
alcohol dependence. A randomized controlled trial. JAMA.
2005;293(13):1617-1625.