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A randomized, double-blind controlled trial comparing treatment outcomes between chlordiazepoxide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent veteran subjects. The objective of this trial is to compare the safety and effectiveness of these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence, withdrawal severity scores, adverse events including ataxia, sedation, cognitive function and alcohol craving.
Chlordiazepoxide 25 mg and matching placebo capsules or gabapentin 300 mg and matching placebo capsules were were used. The chlordiazepoxide/placebo and gabapentin/placebo capsules were not identical in appearance. Study medications were packaged into a 7-day medication organizer. The dosing for each subject was either gabapentin 1200mg or chlordiazepoxide 100 mg orally days 1-3, gabapentin 900 mg or chlordiazepoxide 75 mg day 4, gabapentin 600 mg or chlordiazepoxide 50 mg day 5, and gabapentin 300 mg or chlordiazepoxide 25 mg day 6.
Adherence was assessed by pill counts and serum samples were obtained for study drug analysis. Serum samples were batched and sent to a contract laboratory so that study clinicians were blinded to the results until after the trial was completed. Presence of the assigned study medication in the blood served as a surrogate adherence marker.
Subjects also received prescriptions for daily oral therapeutic multiple vitamin tablets, folic acid 1 mg, and thiamine 100 mg.
A psychiatric history and physical examination, breath alcohol concentration, vital signs, CIWA-Ar (alcohol withdrawal scale), and blood chemistry including transaminases and complete blood cell count were obtained for baseline for all participants. Subjects were seen on weekdays for clinic follow-up appointments. Assessments performed at each study visit included CIWA-Ar, ESS (Epworth Sleepiness Scale), PACS (Penn Alcohol Craving Scale), and a brief examination to document mental status and assess coordination, which included assessment of stance, tandem gait, Romberg test, pronator drift, toe and heel walk, rapid-alternating-movements, and point-to-point movements. Breath alcohol concentration (BAC) was also measured (AlcoSensor, Intoximeters, Inc.) at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlordiazepoxide | Active Comparator | Chlordiazepoxide 25mg capsule or matching placebo capsule |
|
| Gabapentin | Experimental | Gabapentin 300mg capsule or matching placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlordiazepoxide | Drug | 25mg four times daily x 3 days then tapered over 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale (ESS) | ESS is an 8 item-scale and scores range between 0 and 24. The higher the score implies more daytime sleepiness. | 1 week |
| PENN Alcohol Craving Scale | 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) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Stock, PharmD | Salt Lake VA Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George E Wahlen VA Medical Center | Salt Lake City | Utah | 84148 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23780805 | Derived | Stock CJ, Carpenter L, Ying J, Greene T. Gabapentin versus chlordiazepoxide for outpatient alcohol detoxification treatment. Ann Pharmacother. 2013 Jul-Aug;47(7-8):961-9. doi: 10.1345/aph.1R751. Epub 2013 Jun 18. |
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Exclusions: subjects requiring hospitalization, receiving benzodiazepines prior to randomization and subjects not likely to follow instructions.
Subjects recruited from VA outpatient detoxification clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlordiazepoxide | 25mg qid x 3 days, 25mg tid x 1 day, 25mg bid x 1 day, 25mg hs x 1 day then d/c |
| BG001 | Gabapentin | 300mg qid x 3 days, 300mg tid x 1 day, 300mg bid x 1 day, 300mg hs x 1 day then d/c |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Epworth Sleepiness Scale (ESS) | ESS is an 8 item-scale and scores range between 0 and 24. The higher the score implies more daytime sleepiness. | Late withdrawal period days 5-7 | Posted | Mean | 95% Confidence Interval | units on a scale | 1 week |
|
7 days
Daily assessments of mental status, stance, tandem gait, Romberg test, pronator drift, toe and heel walk, rapid-alternating-movements, and point-to-point movements.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chlordiazepoxide | 25mg qid x 3 days, 25mg tid x 1 day, 25mg bid x 1 day, 25mg hs x 1 day then d/c |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Stock | VA Salt Lake City Medical Center | 801-582-1565 | 1172 | christopher.stock@va.gov |
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| ID | Term |
|---|---|
| D002707 | Chlordiazepoxide |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Gabapentin | Drug | 300mg four times daily x 3 days then tapered over 3 days |
|
|
| 1 week |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | PENN Alcohol Craving Scale | 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) | Late withdrawal period days 5-7 | Posted | Mean | 95% Confidence Interval | units on a scale | 1 week |
|
|
|
| Secondary | Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar) | 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 | Late withdrawal period days 5-7 | Posted | Mean | 95% Confidence Interval | units on a scale | 1 week |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Gabapentin | 300mg qid x 3 days, 300mg tid x 1 day, 300mg bid x 1 day, 300mg hs x 1 day then d/c | 0 | 17 | 0 | 17 |
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| D006571 | Heterocyclic Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |