CompletedNCT01014533MAUpdated Dec 6, 2017Results posted

Pharmacotherapy and Mechanisms of Sleep Disturbance in Alcohol Dependence

An interventional study of Placebo dispensed to subject. and Gabapentin dispensed to subject. in Alcohol Dependence and Insomnia, sponsored by Dr. Kirk Brower. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-06.

Sponsored by Dr. Kirk Brower · Not applicable, Interventional, and Other

From the registry’s dates

Registered 2 years 6 months after the study started (first participant enrolled May 2007, registered Nov 2009).

Phase: Not applicable
Study type: Interventional
Enrollment: 59
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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:

To investigate three potential mechanisms of sleep disturbance in alcoholic patients: impaired sleep drive, impaired circadian regulation of alertness, and brain hyperactivation;
To investigate short-term effects of medication on sleep and its regulatory mechanisms in alcoholics;
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.

Conditions studied

Alcohol Dependence
Insomnia

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Keywords

Alcoholism
Alcohol dependence
Insomnia
Dim light melatonin onset
Gabapentin

In context

Dyssomnias

324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.

This study's enrollment of 59 is close to the median of 60 across 251 interventional studies indexed under Dyssomnias.

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Lead sponsor

This is the only study on the registry with Dr. Kirk Brower as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 59 participants (actual)

Study arms

Placebo comparator
Placebo
After 3 nights in the UM sleep lab and randomization, this arm receives placebo for one week. They then return to the sleep lab for the same procedures.
Drug: Placebo dispensed to subject.
Active comparator
Gabapentin
After spending 3 baseline nights in the UM sleep lab, alcohol dependent subjects are randomized. This arm receives gabapentin . On nights 1 and 2 of medication, the dose is 600 mg by mouth 30 min before bedtime. On nights 3-10, the dose is 1200 mg by mouth 30 min before bedtime. On nights 8-10 of medication, subjects return to the UM sleep lab and complete 3 sleep nights with the same procedures. On night 11, the dose is reduced to 600 mg by mouth 30 min before bedtime, and then stopped.
Drug: Gabapentin dispensed to subject.

Interventions

DrugPlacebo dispensed to subject.
Placebo for 11 days, (one pill at bedtime on nights 1 and 2, 2 pills at bedtime on nights 3-10, and 1 pill at bedtime on night 11, then D/C). They return to the Sleep Lab for polysomnography on nights 8 - 10 of medication so their sleep data can be compared.
DrugGabapentin dispensed to subject.
After spending 3 baseline nights in the UM Sleep Lab, alcohol dependent subjects are randomized to receive either gabapentin or placebo for 11 days. (1 pill (600 mg) at bedtime on nights 1 and 2, 2 pills (totalling 1200 mg) at bedtime on nights 3-10, and 1 pill (600 mg) at bedtime on night 11, then D/C). On nights 8 - 10 of medication, subjects return to the lab and sleep 3 more nights with the same procedures.
Also known as: Neurontin is the brand name for Gabapentin.

What researchers measure

Primary outcomes

Percentage of Total Sleep Time in Stage 2 Sleep Pre- and Post-study Medication (Stage 2 Percent)
Electrophysiological measures of sleep stages: percent of total sleep time in stage 2 sleep
Time frame: 1 week
Wake Time After Sleep Onset (WASO) Measured in Sleep Laboratory Recordings Pre- and Post- Study Medication
Wake time after sleep onset (WASO) (number of minutes awake throughout the night after initial sleep onset)
Time frame: 1 week

Secondary outcomes

Relapse to Any Drinking
Relapse to any drinking is counted as participants who drank any beverage alcohol from end of sleep laboratory study (night 10) to twelve weeks later
Time frame: 12 weeks

Results

Posted Nov 1, 2017

Participant flow

Participant flow — Overall Study
Milestone	Placebo	Gabapentin
Started	29	30
Completed	24	25
Not completed	5	5
Withdrew: Protocol violation	3	2
Withdrew: Withdrawal by subject	2	0
Withdrew: Unable to come to appointment	0	3

Outcome measures

PrimaryPercentage of Total Sleep Time in Stage 2 Sleep Pre- and Post-study Medication (Stage 2 Percent)

Electrophysiological measures of sleep stages: percent of total sleep time in stage 2 sleep

Time frame:: 1 week
Reported as:: Mean · percentage of total sleep time

Percentage of Total Sleep Time in Stage 2 Sleep Pre- and Post-study Medication (Stage 2 Percent)
percentage of total sleep time	Placebo	Gabapentin
Stage 2 % pre-intervention	51.3 ± 8.2	53.8 ± 9.2
Stage 2 % post-intervention	50.2 ± 7.9	59.6 ± 9.0

PrimaryWake Time After Sleep Onset (WASO) Measured in Sleep Laboratory Recordings Pre- and Post- Study Medication

Wake time after sleep onset (WASO) (number of minutes awake throughout the night after initial sleep onset)

Time frame:: 1 week
Reported as:: Mean · minutes

Wake Time After Sleep Onset (WASO) Measured in Sleep Laboratory Recordings Pre- and Post- Study Medication
minutes	Placebo	Gabapentin
pre-intervention	16.7 ± 12.5	26.5 ± 19.7
post-intervention	21.9 ± 20.4	14.2 ± 11.6

SecondaryRelapse to Any Drinking

Relapse to any drinking is counted as participants who drank any beverage alcohol from end of sleep laboratory study (night 10) to twelve weeks later

Time frame:: 12 weeks
Reported as:: Count of participants · Participants

Relapse to Any Drinking
Participants	Placebo	Gabapentin
Relapse to Any Drinking	13	14

Adverse events

Collected over 10 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/29 (0%)	0/29 (0%)	2/29 (6.9%)
Gabapentin	0/30 (0%)	0/30 (0%)	4/30 (13.3%)

Most frequent other events

Most frequent other events
Event	Placebo	Gabapentin
irritabilityPsychiatric disorders	2/29	0/30
coldRespiratory, thoracic and mediastinal disorders	0/29	2/30
coughRespiratory, thoracic and mediastinal disorders	0/29	2/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	Gabapentin	Total
Mean	34.9 ± 12.5	37.0 ± 8.9	36.0 ± 10.8

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Gabapentin	Total
Female	6	7	13
Male	23	23	46

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	Gabapentin	Total
Hispanic or Latino	2	4	6
Not Hispanic or Latino	27	26	53
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo	Gabapentin	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	6	7	13
White	21	19	40
More than one race	0	0	0
Unknown or Not Reported	2	4	6

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Placebo	Gabapentin	Total
White	21	19	40
Black	6	7	13
Other	2	4	6

Region of Enrollment
Region of Enrollment(Participants)	Placebo	Gabapentin	Total
United States	29	30	59

Study locations

1 site

University of Michigan Health System
Ann Arbor, Michigan 48109, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01014533
Lead sponsor: Dr. Kirk Brower
Collaborators: National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party: Dr. Kirk Brower (Professor of Psychiatry, University of Michigan) — Sponsor-investigator
First posted: Nov 17, 2009
Start date: May 2007
Primary completion: Sep 2011
Completion: Sep 2011
Results posted: Nov 1, 2017
Last update: Dec 6, 2017

Study contacts

Kirk J Brower, M.D.

principal investigator · University of Michigan

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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