Eszopiclone will lead to significantly greater improvement in sleep compared to placebo in
patients with insomnia that is associated with alcohol dependence in the post-withdrawal
period. The primary outcome measure will be self-reported total sleep time (TST). A
secondary hypothesis is that the treatment of insomnia with eszopiclone in this population
will lead to a statistically significant improvement in reduced drinking behaviors and
improved overall daytime functioning as compared to placebo.
Inclusion Criteria:
- Subjects must be between the ages of 18-65, may be male or female, and from any ethnic
background.
- Individuals must have the capacity to give IRB-approved study consent and have a
stable residence for the 30 days prior to hospitalization.
- Subjects must be hospitalized to treat alcohol dependence (present for 12 or more
months) and have a complaint of chronic insomnia when not drinking.. Subjects must
have one or more periods of abstinence from alcohol of a minimum of 4 weeks duration.
Subjects must report six or less hours TST, on average at least three times per week
during any 4 week abstinent interval..
- Subjects must be medically stable and not likely to require hospitalization for
medical or psychiatric disorders in the month following discharge from the hospital.
- Subjects must be employed prior to hospitalization or have a reasonable prospect of
being employed post-hospitalization.
- Subjects must have a consistent and reliable significant other who lives with the
subject or has daily contact.
- Subjects must profess a willingness to continue abstinence from alcohol and a
willingness to participate in the outpatient rehabilitative treatment for alcoholism.
Such treatments include, but are not limited to regular and continuous (two or more
times per week for four or more weeks) attendance at AA or other 12 step group
meetings, participation in individual or group therapy for rehabilitation for
alcoholism in a public treatment clinic, or treatment in a private practice with a
licensed practitioner specializing in the treatment of alcohol dependence.
Exclusion Criteria:
- Subjects will not be included in the study if they have a current diagnosis of Major
Depressive Episode, current suicidal ideation, or suicidal attempt within 60 days
prior to admission to the study.
- Potential subjects with a lifetime diagnosis of Bipolar Affective Disorder,
Schizophrenia, Borderline Personality Disorder, dementia of any type, or seizure
disorder will not be admitted to the study.
- Subjects with a history of sleep apnea or who have a presumptive clinical diagnosis of
a sleep-related breathing disorder such as a history of snoring, neck size of 18 or
greater, hypertension unresponsive to medications, and a body mass index (BMI) greater
than 30 will be excluded.
- Subjects having liver function studies three times or greater than normal will be
excluded. Any individual who has an unstable medical or psychiatric condition will be
excluded.
- Subjects will be excluded with a diagnosis of any other substance dependence syndrome
other than alcohol dependence, nicotine dependence, and/or caffeine dependence.
- Individuals may have a history of episodic abuse of cannabis, cocaine, and a past
history of abuse of opiates, amphetamines, and hallucinogens will be permitted.
- Any condition or treatment of a condition that is likely to confound the experimental
design or the results will be prohibited by the PI.
- Patients on all typical and atypical antipsychotic medications, including olanzapine,
will be excluded. Other medications to treat chronic medical or psychiatric illnesses
that the subject was on stably for 30 days prior to hospitalization may be continued
and are not exclusionary. Patients must not consistently use benzodiazepines in the 30
days prior to hospitalization or outpatient treatment.
- New medications that are added to the subject's care during the course of
hospitalization that may improve or diminish sleep in any of its measures are
exclusionary. Examples are benzodiazepines, and stimulants. Medications known to
alter the metabolism of eszopiclone such as CYP3A4 potent inhibitors including but not
limited to ketoconazole, itraconazole, clarithromycin, nefazodone, and several
anti-viral compounds will be exclusionary.
