Gabapentin for Alcohol Relapse Prevention

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT02349477
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Duration (Months): 45.8
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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").

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder; Alcohol Withdrawal	Drug: Gabapentin; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Aug 27, 2018
• Actual Study Completion Date: Aug 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gabapentin Gabapentin up to 1200 mg per day in 3 divided doses	Drug: Gabapentin; gaba potentiating medication; Other Names: neurontin
Placebo Comparator: placebo matching placebo	Drug: Placebo; a pill that looks exactly like the active medication but does not contain medication; Other Names: Sugar Pill

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

• Principal Investigator: Raymond F Anton, MD, Medical University of South Carolina

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2014

More Information

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT02349477
• Other Study ID Numbers: Pro00032587
• First Posted: Jan 29, 2015
• Last Update Posted: Nov 4, 2019
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Alcoholism; Gabapentin

Study Results

Participant Flow

Pre-assignment Detail	The discrepancy of 6 participants is due to those subjects either violating protocol or not having evaluable data.

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication	matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication
Period Title: Overall Study
STARTED	44	46
COMPLETED	31	28
NOT COMPLETED	13	18

Baseline Characteristics

Arm/Group Title	Gabapentin	Placebo	Total
Arm/Group Description	Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication	matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication	Total of all reporting groups
Overall Participants	44	46	90
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.3 (10.4)	48.9 (9.9)	49.6 (10.1)
Sex: Female, Male (Count of Participants)
Female	10 22.7%	11 23.9%	21 23.3%
Male	34 77.3%	35 76.1%	69 76.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 2.2%	1 1.1%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 6.8%	1 2.2%	4 4.4%
White	41 93.2%	44 95.7%	85 94.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
% Heavy Drinking Days (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	82.9 (23)	82.5 (21.6)	82.7 (22.2)

Outcome Measures

1. Primary Outcome

Title	Percent of Subjects With no Heavy Drinking Days (PSNHDD)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication	matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication
Measure Participants	44	46
Count of Participants [Participants]	12 27.3%	4 8.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo
	Comments	This analysis compares between Gabapentin and Placebo, the number of individuals who reported no heavy drinking days throughout the entire trial, corrected for %dCDT.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.028
	Comments
	Method	Regression, Logistic
	Comments	This is the p-value output from the logistic regression model where medication group predicted the discrete variable for no heavy drinking days.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percent of Subjects With no Drinking Days (PSNDD)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gabapentin	Placebo
Arm/Group Description	Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication	matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication
Measure Participants	44	46
Count of Participants [Participants]	8 18.2%	2 4.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo
	Comments	This analysis compares between Gabapentin and Placebo, the number of individuals who reported no drinking days (abstinence) throughout the entire trial, corrected for %dCDT.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.053
	Comments
	Method	Regression, Logistic
	Comments	This is the p-value output from the logistic regression model where medication group predicted the discrete variable for abstinence.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Other Pre-specified Outcome

Title	Number of Participants With No Drinking Days by AWS Score and Medication
Description	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

Outcome Measure Data

Analysis Population Description

The data for this analysis were split into two subgroups, based on the median split of AWS.

Arm/Group Title	Low AWS/Gabapentin	Low AWS/Placebo	High AWS/Gabapentin	High AWS/Placebo
Arm/Group Description	Low on AWS median split variable, Gabapentin	Low on AWS median split variable, Placebo	High on AWS median split variable, Gabapentin	High on AWS median split variable, Placebo
Measure Participants	22	23	22	23
Count of Participants [Participants]	2 4.5%	3 6.5%	10 11.1%	1 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	High AWS/Gabapentin, High AWS/Placebo
	Comments	For the High AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo
	Comments	For the Low AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.67
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	Entire study - 16 weeks.
Adverse Event Reporting Description	Participants were evaluated via the SAFTEE interview 9 times throughout the 16 week period. We report the whole SAFTEE.
Arm/Group Title	Gabapentin		Placebo
Arm/Group Description	Gabapentin up to 1200 mg per day in 3 divided doses Gabapentin: gaba potentiating medication		matching placebo Placebo: a pill that looks exactly like the active medication but does not contain medication
All Cause Mortality
	Gabapentin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/46 (0%)
Serious Adverse Events
	Gabapentin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Gabapentin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/44 (100%)		44/46 (95.7%)
Gastrointestinal disorders
Abdominal Pain	10/44 (22.7%)	12	11/46 (23.9%)	16
Diarrhea	23/44 (52.3%)	62	23/46 (50%)	42
Nausea	14/44 (31.8%)	26	18/46 (39.1%)	33
Vomiting	9/44 (20.5%)	14	6/46 (13%)	11
General disorders
Decreased Appetite	12/44 (27.3%)	18	11/46 (23.9%)	13
Decreased Libido	12/44 (27.3%)	24	5/46 (10.9%)	11
Fatigue	30/44 (68.2%)	122	30/46 (65.2%)	108
Increased Appetite	23/44 (52.3%)	52	18/46 (39.1%)	32
Increased Libido	7/44 (15.9%)	8	4/46 (8.7%)	6
Insomnia	31/44 (70.5%)	92	33/46 (71.7%)	130
Somnolence	6/44 (13.6%)	13	6/46 (13%)	7
Nervous system disorders
Dizziness	25/44 (56.8%)	60	15/46 (32.6%)	27
Headache	32/44 (72.7%)	129	34/46 (73.9%)	89
Psychiatric disorders
Depression	24/44 (54.5%)	80	22/46 (47.8%)	60
Nervousness/Anxiety	35/44 (79.5%)	172	32/46 (69.6%)	127
Suicidal Ideation	4/44 (9.1%)	12	2/46 (4.3%)	2
Skin and subcutaneous tissue disorders
Itching	10/44 (22.7%)	26	9/46 (19.6%)	21
Rash	7/44 (15.9%)	17	5/46 (10.9%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.