Pharmacotherapy and Mechanisms of Sleep Disturbance in Alcohol Dependence
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
Insomnia and other sleep abnormalities are common, persistent, and associated with relapse in
alcohol-dependent patients. The overall, long-term objectives of the proposed research are to
investigate the neurophysiologic mechanisms of sleep disturbance that are associated with
relapse in patients with alcohol dependence, and to target those mechanisms with medication
in order to reduce relapse risk.
The specific research aims are:
1. To investigate three potential mechanisms of sleep disturbance in alcoholic patients:
impaired sleep drive, impaired circadian regulation of alertness, and brain
hyperactivation;
2. To investigate short-term effects of medication on sleep and its regulatory mechanisms
in alcoholics;
3. To investigate the short-term clinical course of alcoholism as a function of baseline
sleep parameters.
In Study Phases I & II (Screening & Baseline: 10+ days), subjects are assessed to diagnose
alcohol dependence, determine baseline values for drinking and sleeping, and rule out
confounding sleep-impairing causes.
Phase III (Medication: 10 days), is a randomized, double-blind parallel design comparison of
gabapentin vs. placebo on mechanisms of sleep. It is not a therapeutic or clinical trial.
Phases II & III each have 7 days of monitoring sleep and activity, followed by 3 nights in
the University of Michigan (UM) sleep laboratory to assess all-night EEG activity and
Dim-Light Melatonin Onset (DLMO), a measure of circadian rhythm.
Phase IV is a 2-day medication taper and Phase V (Follow-up) consists of one visit or
telephone call after 12 weeks to assess course of drinking.
In summary, sleep disturbance in alcoholic patients increases their risk of relapse. This
study proposes to investigate the mechanisms causing sleep disturbance in alcoholics and to
determine if those mechanisms predict return to drinking after 12 weeks.
Relevance: Alcoholism is a devastating chronic disorder that in any one year affects 10% of
adults, costs over $185 billion, and causes more than 100,000 deaths in the U.S. Despite
treatment, most alcoholic patients achieve only short-term abstinence. Medically-based
treatment improvements are needed that target neurophysiologic mechanisms of relapse. Overall
public health will be improved by developing science-based treatments that can augment
existing, but only partially effective, treatment approaches.
Phase:
N/A
Details
Lead Sponsor:
Dr. Kirk Brower
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institutes of Health (NIH)