Alcohol Use Disorder, Alcohol Withdrawal
Conditions
Brief summary
This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a sugar pill).
Detailed description
This treatment study is a 16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a sugar pill). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.
Interventions
DRUGGabapentin
gaba potentiating medication
DRUGPlacebo
a pill that looks exactly like the active medication but does not contain medication
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Meets criteria for alcohol use disorder based on DSM-5 criteria 2. Meets criteria for history of alcohol withdrawal based on DSM-5 criteria 3. Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.
Exclusion criteria
1. Significant psychiatric or medical illness 2. No other substance abuse 3. Taking other medications known to treat alcohol use disorder 4. Unstable living arrangements 5. Significant legal problems pending
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With no Heavy Drinking Days (PSNHDD) | 4 months | The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With no Drinking Days (PSNDD) | 4 months | The secondary dependent variable will be percent of subjects with no drinking days (total abstinence). Participants will report their daily alcohol use with using a daily calendar. Abstinence is corrected for %dCDT. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With No Drinking Days by AWS Score and Medication | 4 months | This analysis examines the interaction of medication group with a median split of the baseline Alcohol Withdrawal Scale (AWS) scores on the primary outcome variable (no heavy drinking days, corrected for %dCDT). Participants will report their daily alcohol use with using a daily calendar. AWS ranges from 0 to 44 where higher values correspond with more serious withdrawal (worse outcome). |
Countries
United States
Participant flow
Pre-assignment details
The discrepancy of 6 participants is due to those subjects either violating protocol or not having evaluable data.
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin Gabapentin up to 1200 mg per day in 3 divided doses
Gabapentin: gaba potentiating medication | 44 |
| Placebo matching placebo
Placebo: a pill that looks exactly like the active medication but does not contain medication | 46 |
| Total | 90 |
Baseline characteristics
| Characteristic | Gabapentin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 10.4 | 48.9 years STANDARD_DEVIATION 9.9 | 49.6 years STANDARD_DEVIATION 10.1 |
| % Heavy Drinking Days | 82.9 percent STANDARD_DEVIATION 23 | 82.5 percent STANDARD_DEVIATION 21.6 | 82.7 percent STANDARD_DEVIATION 22.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 41 Participants | 44 Participants | 85 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 34 Participants | 35 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 46 |
| other Total, other adverse events | 44 / 44 | 44 / 46 |
| serious Total, serious adverse events | 0 / 44 | 0 / 46 |
Outcome results
Primary
Percent of Subjects With no Heavy Drinking Days (PSNHDD)
The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gabapentin | Percent of Subjects With no Heavy Drinking Days (PSNHDD) | 12 Participants |
| Placebo | Percent of Subjects With no Heavy Drinking Days (PSNHDD) | 4 Participants |
Comparison: This analysis compares between Gabapentin and Placebo, the number of individuals who reported no heavy drinking days throughout the entire trial, corrected for %dCDT.p-value: 0.028Regression, Logistic
Secondary
Percent of Subjects With no Drinking Days (PSNDD)
The secondary dependent variable will be percent of subjects with no drinking days (total abstinence). Participants will report their daily alcohol use with using a daily calendar. Abstinence is corrected for %dCDT.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gabapentin | Percent of Subjects With no Drinking Days (PSNDD) | 8 Participants |
| Placebo | Percent of Subjects With no Drinking Days (PSNDD) | 2 Participants |
Comparison: This analysis compares between Gabapentin and Placebo, the number of individuals who reported no drinking days (abstinence) throughout the entire trial, corrected for %dCDT.p-value: 0.053Regression, Logistic
Other Pre-specified
Number of Participants With No Drinking Days by AWS Score and Medication
This analysis examines the interaction of medication group with a median split of the baseline Alcohol Withdrawal Scale (AWS) scores on the primary outcome variable (no heavy drinking days, corrected for %dCDT). Participants will report their daily alcohol use with using a daily calendar. AWS ranges from 0 to 44 where higher values correspond with more serious withdrawal (worse outcome).
Time frame: 4 months
Population: The data for this analysis were split into two subgroups, based on the median split of AWS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gabapentin | Number of Participants With No Drinking Days by AWS Score and Medication | 2 Participants |
| Placebo | Number of Participants With No Drinking Days by AWS Score and Medication | 3 Participants |
| High AWS/Gabapentin | Number of Participants With No Drinking Days by AWS Score and Medication | 10 Participants |
| High AWS/Placebo | Number of Participants With No Drinking Days by AWS Score and Medication | 1 Participants |
Comparison: For the High AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.p-value: 0.001Chi-squared
Comparison: For the Low AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.p-value: 0.67Chi-squared