Trial Outcomes & Findings for Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal (NCT NCT01573052)

NCT ID: NCT01573052

Last Updated: 2020-08-17

Results Overview

ESS is an 8 item-scale and scores range between 0 and 24. The higher the score implies more daytime sleepiness.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 26 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2020-08-17

Participant Flow

Subjects recruited from VA outpatient detoxification clinic

Exclusions: subjects requiring hospitalization, receiving benzodiazepines prior to randomization and subjects not likely to follow instructions.

Participant milestones

Measure	Chlordiazepoxide 25mg four times daily x 3 days, 25mg three times daily x 1 day, 25mg twice daily x 1 day, 25mg at bedtime x 1 day then discontinue	Gabapentin 300mg four times daily x 3 days, 300mg three times daily x 1 day, 300mg twice daily x 1 day, 300mg at bedtime x 1 day then discontinue
Overall Study STARTED	9	17
Overall Study COMPLETED	6	11
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal

Baseline characteristics by cohort

Measure	Chlordiazepoxide n=9 Participants 25mg qid x 3 days, 25mg tid x 1 day, 25mg bid x 1 day, 25mg hs x 1 day then d/c	Gabapentin n=17 Participants 300mg qid x 3 days, 300mg tid x 1 day, 300mg bid x 1 day, 300mg hs x 1 day then d/c	Total n=26 Participants Total of all reporting groups
Age, Continuous	55.8 years STANDARD_DEVIATION 4.8 • n=5 Participants	51.1 years STANDARD_DEVIATION 7.7 • n=7 Participants	52.7 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	17 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Late withdrawal period days 5-7

ESS is an 8 item-scale and scores range between 0 and 24. The higher the score implies more daytime sleepiness.

Outcome measures

Measure	Chlordiazepoxide n=9 Participants 25mg four times daily x 3 days, 25mg three times daily x 1 day, 25mg twice daily x 1 day, 25mg at bedtime x 1 day then discontinue	Gabapentin n=17 Participants 300mg four times daily x 3 days, 300mg three times daily x 1 day, 300mg twice daily x 1 day, 300mg at bedtime x 1 day then discontinue
Epworth Sleepiness Scale (ESS)	6.35 units on a scale Interval 3.13 to 9.57	2.65 units on a scale Interval 0.44 to 4.85

PRIMARY outcome

Timeframe: 1 week

Population: Late withdrawal period days 5-7

PENN is a 5 item self-rated scale of alcohol craving. Scores range from 0 (little craving for alcohol) to 30 (irresistable urge to drink alcohol)

Outcome measures

Measure	Chlordiazepoxide n=9 Participants 25mg four times daily x 3 days, 25mg three times daily x 1 day, 25mg twice daily x 1 day, 25mg at bedtime x 1 day then discontinue	Gabapentin n=17 Participants 300mg four times daily x 3 days, 300mg three times daily x 1 day, 300mg twice daily x 1 day, 300mg at bedtime x 1 day then discontinue
PENN Alcohol Craving Scale	16.78 units on a scale Interval 10.92 to 22.64	10.74 units on a scale Interval 7.09 to 14.39

SECONDARY outcome

Timeframe: 1 week

Population: Late withdrawal period days 5-7

CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Many previously publications suggest a total score of 8-10 is severe enough to warrant medication treatment. Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity

Outcome measures

Measure	Chlordiazepoxide n=9 Participants 25mg four times daily x 3 days, 25mg three times daily x 1 day, 25mg twice daily x 1 day, 25mg at bedtime x 1 day then discontinue	Gabapentin n=17 Participants 300mg four times daily x 3 days, 300mg three times daily x 1 day, 300mg twice daily x 1 day, 300mg at bedtime x 1 day then discontinue
Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar)	3.29 units on a scale Interval -0.28 to 6.88	4.33 units on a scale Interval 2.1 to 6.56

Adverse Events

Chlordiazepoxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gabapentin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christopher Stock

VA Salt Lake City Medical Center

Phone: 801-582-1565

Email: christopher.stock@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place