Pharmacotherapy and Mechanisms of Sleep Disturbance in Alcohol Dependence
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/8/2017 |
| Start Date: | May 2007 |
| End Date: | September 2011 |
This is a Study Exploring the Reasons Why People With Alcohol Dependence Have Sleep Disturbances, and Whether or Not a Study Medication, Gabapentin, vs. Placebo, Affects Those Sleep Patterns.
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.
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.
Inclusion Criteria:
- Meet DSM-IV criteria for alcohol dependence (as confirmed by the SCID)
- Between 3 and 12 weeks since last drink (as measured by the TLFB)
- At least 2 weeks since last detoxification medication, if relevant
- An alcohol withdrawal rating score < 8 (as measured by the CIWA-Ar) to rule out acute
alcohol withdrawal effects on sleep.
- Expresses a desire to stop drinking or a willingness to abstain from alcohol and/or
other drugs of abuse (except nicotine) during the course of the study
Exclusion Criteria:
- Subjects who meet DSM-IV criteria for dependence on any psychoactive substance other
than alcohol (except nicotine) in the past 3 months (per SCID interview).
- Subjects with a current (past 1 month) DSM-IV diagnosis of panic disorder, generalized
anxiety disorder, post-traumatic stress disorder, major depression, anorexia nervosa,
or bulimia nervosa (per SCID interview) and/or that require ongoing psychotropic
medication.
- Subjects who have a lifetime diagnosis meeting DSM-IV criteria for bipolar disorder,
schizophrenia, schizoaffective disorder, delusional (paranoid) disorders, or
obsessive-compulsive disorder.
- Urine drug screen positive for amphetamines, barbiturates, benzodiazepines, cocaine,
marijuana, or opioids. (If positive, subjects have one opportunity to test negative
after a week of abstinence).
- Medical disorders or pain syndromes that may affect sleep; history of head trauma with
loss of consciousness; history of seizures (except alcohol-related seizures).
- Subjects with elevated renal tests (blood urea nitrogen or creatinine), because
gabapentin is renally eliminated, or elevated liver transaminases (>3X normal), or
abnormal thyroid tests as thyroid problems can affect sleep.
- Sleep disorders other than insomnia such as sleep apnea/hypopnea index >10 per hour or
periodic limb movement disorder; PLM>15 movements per hour with arousals.
- Taking medications known to affect sleep (e.g., antidepressants, anticonvulsants,
centrally acting antihistamines, neuroleptics, sedative-hypnotics, stimulants,
centrally acting antihypertensives [alpha-methyldopa, reserpine, clonidine], oral
corticosteroids, and theophylline within the past 2 weeks or 5 weeks for fluoxetine).
- Subjects taking medications used to treat addiction (e.g., disulfiram, naltrexone or
acamprosate) are excluded because of unknown effects on sleep.
- Subjects who do evening or midnight shift work. (Subjects who have traveled across
multiple time zones in the previous two weeks will be included only at the discretion
of the P.I.)
- Pregnancy, breast feeding, or inadequate contraception in women of child-bearing
potential.
- Subjects who are unable or unlikely to follow the study protocol in the investigator
's opinion, because of cognitive deficits (Mini-Mental State Exam score < 27), a
personality disorder, a serious suicide risk, dangerousness to others, illiteracy, or
unstable or distant living situation.
- Subjects with a known allergy, hypersensitivity or contraindication to study
medication.
We found this trial at
1
site
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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