InsomniaPhase 4NCT00666796
A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects
A Phase 4 study testing Ethanol and Gabapentin in people with Insomnia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Ethanol and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to May 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers in good health aged 21 to 50 (inclusive) years who weigh 50 to 100 kg (110-220 lbs.)
- Experience with alcohol, defined as mild to moderate use of alcohol, ie, maximum of 14 alcoholic drinks per week
Who cannot join
- Recent history (within 2 years) of, or current treatment for, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition
- Recent history (within 2 years) of, or clinical evidence of significant unstable or uncontrolled respiratory (including asthma and congestive obstructive pulmonary disease), cardiovascular, gastrointestinal, hepatic, renal, endocrine, neurologic (including seizures), psychiatric or other chronic disease
- History of alcoholism or drug abuse; recreational drug use within the past 30 days; use of benzodiazepines, Ambien®, Sonata®, antidepressants or psychoactive medication within 30 days prior to screening; use of any other sedative, hypnotic, antihistamine, anticholinergic, melatonin, DHEA or herbal sleep/relaxation remedy within 7 days prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, 4-way Crossover, Placebo-Controlled, Single Center Trial to Evaluate the Potential Pharmacodynamic Interaction Between Gabapentin 500 mg and Ethanol in Healthy Volunteers
The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol
- Conditions
- Insomnia
- Being tested
- Placebo ethanol, Ethanol, Placebo, Gabapentin
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ethanolDrug
Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
EthanolDrug
Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
PlaceboDrug
Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
GabapentinDrug
Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
EthanolDrug
Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
PlaceboDrug
Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
GabapentinDrug
Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
Placebo ethanolDrug
Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Placebo ethanol; Drug: Placebo |
| B | Experimental | Not described Receives: Drug: Ethanol; Drug: Gabapentin |
| C | Experimental | Not described Receives: Drug: Ethanol; Drug: Placebo |
| D | Experimental | Not described Receives: Drug: Gabapentin; Drug: Placebo ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects
Measured: 2 hours post-dose
Secondary outcomes (10)
Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects
Measured: 2 and 6 hours post-dose
Change from pre-dose in PVT for ITT subjects
Measured: 2 and 6 hours post-dose
Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects
Measured: 2 and 6 hours post-dose
Change from pre-dose in BSRT for ITT subjects
Measured: 2 and 6 hours post-dose
Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects
Measured: 2, 6, and 7.5 hours post-dose
Change from pre-dose in SSS for ITT subjects
Measured: 2, 6, and 7.5 hours post-dose
Adverse events
Measured: Throughout study duration
Vital signs
Measured: Throughout study duration
Change from pre-dose in PVT for completed subjects
Measured: 6 hours post-dose
Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects
Measured: 2 and 6 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startApr 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666796
- Sponsor's protocol ID
- A9451149
- Status last verified
- Apr 2008
- First submitted
- 23 Apr 2008
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, 4-way Crossover, Placebo-Controlled, Single Center Trial to Evaluate the Potential Pharmacodynamic Interaction Between Gabapentin 500 mg and Ethanol in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00666796
- Acronym / sponsor ID
- A9451149
- Conditions
- Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- May 2005 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Placebo ethanol, Drug: Placebo |
| B | Experimental | Drug: Ethanol, Drug: Gabapentin |
| C | Experimental | Drug: Ethanol, Drug: Placebo |
| D | Experimental | Drug: Gabapentin, Drug: Placebo ethanol |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteers in good health aged 21 to 50 (inclusive) years who weigh 50 to 100 kg (110-220 lbs.)
- Experience with alcohol, defined as mild to moderate use of alcohol, ie, maximum of 14 alcoholic drinks per week
Key exclusion criteria (3 listed)
- Recent history (within 2 years) of, or current treatment for, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition
- Recent history (within 2 years) of, or clinical evidence of significant unstable or uncontrolled respiratory (including asthma and congestive obstructive pulmonary disease), cardiovascular, gastrointestinal, hepatic, renal, endocrine, neurologic (including seizures), psychiatric or other chronic disease
- History of alcoholism or drug abuse; recreational drug use within the past 30 days; use of benzodiazepines, Ambien®, Sonata®, antidepressants or psychoactive medication within 30 days prior to screening; use of any other sedative, hypnotic, antihistamine, anticholinergic, melatonin, DHEA or herbal sleep/relaxation remedy within 7 days prior to screening
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 |
|---|---|---|
| Placebo ethanolMatched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint | Drug | A |
| EthanolEthanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint | Drug | B |
| PlaceboMatched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint | Drug | A |
| GabapentinGabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint | Drug | B |
| EthanolEthanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint | Drug | C |
| PlaceboMatched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint | Drug | C |
| GabapentinGabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint | Drug | D |
| Placebo ethanolMatched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint | Drug | D |
Primary outcome
Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects
Time frame: 2 hours post-dose
10 secondary outcomes
Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects
Time frame: 2 and 6 hours post-dose
Change from pre-dose in PVT for ITT subjects
Time frame: 2 and 6 hours post-dose
Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects
Time frame: 2 and 6 hours post-dose
Change from pre-dose in BSRT for ITT subjects
Time frame: 2 and 6 hours post-dose
Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects
Time frame: 2, 6, and 7.5 hours post-dose
Change from pre-dose in SSS for ITT subjects
Time frame: 2, 6, and 7.5 hours post-dose
Adverse events
Time frame: Throughout study duration
Vital signs
Time frame: Throughout study duration
Change from pre-dose in PVT for completed subjects
Time frame: 6 hours post-dose
Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects
Time frame: 2 and 6 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Ethanol and Gabapentin in people with Insomnia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 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 2 inclusion and 3 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 2 Feb 2021. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects (time frame: 2 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2021.