Alcohol WithdrawalPhase 4NCT01573052
Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal
A Phase 4 study testing Chlordiazepoxide and Gabapentin in people with Alcohol Withdrawal, run by VA Salt Lake City Health Care System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcohol Withdrawal
- What is being tested?
- Chlordiazepoxide and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcohol dependent at risk for withdrawal symptoms
Who cannot join
- Benzodiazepine dependent
Trial locations and contacts
1 site in 1 country.
United States1 site
George E Wahlen VA Medical Center
Salt Lake City, Utah, 84148
About this study
Official title: Comparison of Chlordiazepoxide and Gabapentin for Outpatient Alcohol Detoxification Treatment
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.
Read the detailed description
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.
- Conditions
- Alcohol Withdrawal
- Being tested
- Chlordiazepoxide, Gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlordiazepoxideDrug
Also called Librium
25mg four times daily x 3 days then tapered over 3 days
GabapentinDrug
Also called Neurontin
300mg four times daily x 3 days then tapered over 3 days
| Study group | Role | What they receive |
|---|---|---|
| Chlordiazepoxide | Active comparator | Chlordiazepoxide 25mg capsule or matching placebo capsule Receives: Drug: Chlordiazepoxide |
| Gabapentin | Experimental | Gabapentin 300mg capsule or matching placebo capsule Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 1 week
Secondary outcomes (1)
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startMar 2004
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol WithdrawalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Salt Lake City Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Christopher J. Stock, PharmD, VA Salt Lake City Health Care System
- Investigators
- Christopher J Stock, PharmD, Principal investigator, Salt Lake VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573052
- Sponsor's protocol ID
- UU40574
- Status last verified
- Aug 2020
- First submitted
- 4 Apr 2012
- Last updated
- 17 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23780805
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Chlordiazepoxide and Gabapentin for Outpatient Alcohol Detoxification Treatment
- ClinicalTrials.gov ID
- NCT01573052
- Acronym / sponsor ID
- UU40574
- Conditions
- Alcohol Withdrawal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- VA Salt Lake City Health Care SystemUS federal agency
- Study start
- Mar 2004
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Posted 17 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlordiazepoxide | Active comparator | Drug: ChlordiazepoxideChlordiazepoxide 25mg capsule or matching placebo capsule |
| Gabapentin | Experimental | Drug: GabapentinGabapentin 300mg capsule or matching placebo capsule |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alcohol dependent at risk for withdrawal symptoms
Key exclusion criteria (1 listed)
- Benzodiazepine dependent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlordiazepoxideAlso: Librium25mg four times daily x 3 days then tapered over 3 days | Drug | Chlordiazepoxide |
| GabapentinAlso: Neurontin300mg four times daily x 3 days then tapered over 3 days | Drug | Gabapentin |
Primary outcome
Epworth Sleepiness Scale (ESS)
Time frame: 1 week
ESS is an 8 item-scale and scores range between 0 and 24. The higher the score implies more daytime sleepiness.
PENN Alcohol Craving Scale
Time frame: 1 week
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 secondary outcome
Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar)
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23780805Stock 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Stock, PharmD principal investigator
Salt Lake VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlordiazepoxide and Gabapentin in people with Alcohol Withdrawal, run by VA Salt Lake City Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epworth Sleepiness Scale (ESS) (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01573052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.