Trial Outcomes & Findings for Pharmacotherapy and Mechanisms of Sleep Disturbance in Alcohol Dependence (NCT NCT01014533)
NCT ID: NCT01014533
Last Updated: 2017-12-06
Results Overview
Electrophysiological measures of sleep stages: percent of total sleep time in stage 2 sleep
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
1 week
Results posted on
2017-12-06
Participant Flow
Participant milestones
| Measure |
Placebo
Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.
Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg 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.
|
Gabapentin
Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 -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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.
Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg 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.
|
Gabapentin
Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights 1 -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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
unable to come to appointment
|
0
|
3
|
Baseline Characteristics
Pharmacotherapy and Mechanisms of Sleep Disturbance in Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
Alcohol-dependent subjects spend 3 nights in the University of Michigan (UM) sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.
Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the University of Michigan (UM) Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg 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.
|
Gabapentin
n=30 Participants
Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. 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.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
36.0 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekElectrophysiological measures of sleep stages: percent of total sleep time in stage 2 sleep
Outcome measures
| Measure |
Placebo
n=24 Participants
Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.
Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg 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.
|
Gabapentin
n=25 Participants
Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights1 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.
|
|---|---|---|
|
Percentage of Total Sleep Time in Stage 2 Sleep Pre- and Post-study Medication (Stage 2 Percent)
Stage 2 % pre-intervention
|
51.3 percentage of total sleep time
Standard Deviation 8.2
|
53.8 percentage of total sleep time
Standard Deviation 9.2
|
|
Percentage of Total Sleep Time in Stage 2 Sleep Pre- and Post-study Medication (Stage 2 Percent)
Stage 2 % post-intervention
|
50.2 percentage of total sleep time
Standard Deviation 7.9
|
59.6 percentage of total sleep time
Standard Deviation 9.0
|
PRIMARY outcome
Timeframe: 1 weekWake time after sleep onset (WASO) (number of minutes awake throughout the night after initial sleep onset)
Outcome measures
| Measure |
Placebo
n=24 Participants
Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.
Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg 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.
|
Gabapentin
n=25 Participants
Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights1 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.
|
|---|---|---|
|
Wake Time After Sleep Onset (WASO) Measured in Sleep Laboratory Recordings Pre- and Post- Study Medication
pre-intervention
|
16.7 minutes
Standard Deviation 12.5
|
26.5 minutes
Standard Deviation 19.7
|
|
Wake Time After Sleep Onset (WASO) Measured in Sleep Laboratory Recordings Pre- and Post- Study Medication
post-intervention
|
21.9 minutes
Standard Deviation 20.4
|
14.2 minutes
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 12 weeksRelapse to any drinking is counted as participants who drank any beverage alcohol from end of sleep laboratory study (night 10) to twelve weeks later
Outcome measures
| Measure |
Placebo
n=24 Participants
Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.
Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg 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.
|
Gabapentin
n=25 Participants
Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. On nights1 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.
|
|---|---|---|
|
Relapse to Any Drinking
|
13 Participants
|
14 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Gabapentin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=29 participants at risk
Alcohol-dependent subjects spend 3 nights in the UM sleep lab, then are randomized to receive placebo for one week. They then return to the sleep lab for the same procedures.
Placebo dispensed to subjects: Alcohol-dependent subjects have polysomnography in the UM Sleep Lab for three nights, then are randomized to receive placebo for 11 days, (1 pill to represent 600mg at bedtime on nights 1 and 2, 2 pills to represent 1200mg at bedtime on nights 3-10, and 1 pill to represent 600mg 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.
|
Gabapentin
n=30 participants at risk
Alcohol-dependent subjects are randomized to receive gabapentin after spending 3 baseline nights in the UM sleep lab. 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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
cold
|
0.00%
0/29 • 10 days
|
6.7%
2/30 • 10 days
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/29 • 10 days
|
6.7%
2/30 • 10 days
|
|
Psychiatric disorders
irritability
|
6.9%
2/29 • 10 days
|
0.00%
0/30 • 10 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place