Alcohol DrinkingNCT00330434
Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism
A study testing Trial Withdrawn 1 and Trial Withdrawn 2 in people with Alcohol Drinking and Depression, run by Tufts University at 1 site in United States.
Trial summary
The two purposes of this study are 1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has 1. on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and 2. on the stimulant effect of bupropion and 2. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Depression, Smoking Cessation
- What is being tested?
- Trial Withdrawn 1 and Trial Withdrawn 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Apr 2008
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults who are 21 - 55 years of age.
- Either 1) Moderate-to-heavy drinkers who drink on average more than 14 but less than 28 drinks per week; OR 2) adults who normally abstain from drinking alcohol.
Who cannot join
- Participants who are currently taking prescription medications (including oral contraceptives)
- Pregnancy
- Body mass index (BMI) greater than 30
- History of seizures or eating disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Medicine
Boston, Massachusetts, 02111
About this study
Official title: Human CYP2B6: Induction by Ethanol and Polymorphisms
The two purposes of this study are
- to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has
- on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and
- on the stimulant effect of bupropion and
- to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has
- on the blood levels of bupropion and its major breakdown products in the blood and
- on the stimulant effect of bupropion.
Read more
Two groups of volunteers will be recruited for this study:
- volunteers who drink moderate to heavy amounts of alcohol frequently and
- volunteers who usually do not drink alcohol.
Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.
- Being tested
- Trial Withdrawn 1, Trial Withdrawn 2
- Keywords
- Alcohol, Bupropion, Chlorzoxazone, Interaction, Induction, Depression, Smoking, Drinking, Cytochrome P450 Enzyme, CYP2B6, CYP2E1, Pharmacogenetics, Pharmacokinetics, Pharmacodynamics, Boston, Tufts University
- Medical subject headings
- Alcohol Drinking, Depression, Smoking Cessation, Attention Deficit Disorder with Hyperactivity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trial Withdrawn 1Other
Trial Withdrawn 1
Trial Withdrawn 2Other
Trial Withdrawn 2
| Study group | Role | What they receive |
|---|---|---|
| Trial Withdrawn 2 | Other | Trial Withdrawn 2 Receives: Other: Trial Withdrawn 2 |
| Trial Withdrawn 1 | Other | Trial Withdrawn 1 Receives: Other: Trial Withdrawn 1 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startDec 2005
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Study was a F32 Fellowship. Trial was proposed however Principle Investigator does not believe trial took place.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- David J. Greenblatt, MD, Principal investigator, Tufts University; Chair of Department of Pharmacology and Experimental Therapeutics, Sackler SchoolMichael H. Court, BVsc, PhD, Principal investigator, Tufts University, Department of Pharmacology and Experimental Therapeutics, Sackler School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330434
- Sponsor's protocol ID
- NIAAAGRE15647
- Other IDs
- F32AA015647-01A1, 1F32AA015647-01A1
- Status last verified
- Nov 2020
- First submitted
- 25 May 2006
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Hesse LM, Venkatakrishnan K, Court MH, von Moltke LL, Duan SX, Shader RI, Greenblatt DJ. CYP2B6 mediates the in vitro hydroxylation of bupropion: potential drug interactions with other antidepressants. Drug Metab Dispos. 2000 Oct;28(10):1176-83.
PubMed 10997936Hesse LM, He P, Krishnaswamy S, Hao Q, Hogan K, von Moltke LL, Greenblatt DJ, Court MH. Pharmacogenetic determinants of interindividual variability in bupropion hydroxylation by cytochrome P450 2B6 in human liver microsomes. Pharmacogenetics. 2004 Apr;14(4):225-38. doi: 10.1097/00008571-200404000-00002.
PubMed 15083067
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human CYP2B6: Induction by Ethanol and Polymorphisms
- ClinicalTrials.gov ID
- NCT00330434
- Acronym / sponsor ID
- NIAAAGRE15647
- Keywords
- Alcohol, Bupropion, Chlorzoxazone, Interaction, Induction, Depression, Smoking, Drinking
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was a F32 Fellowship. Trial was proposed however Principle Investigator does not believe trial took place.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Dec 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 26 May 2006 (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 two purposes of this study are
- to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has
- on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and
- on the stimulant effect of bupropion and
- to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has
- on the blood levels of bupropion and its major breakdown products in the blood and
- on the stimulant effect of bupropion.
Two groups of volunteers will be recruited for this study:
- volunteers who drink moderate to heavy amounts of alcohol frequently and
- volunteers who usually do not drink alcohol.
Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Withdrawn 2 | Other | Other: Trial Withdrawn 2Trial Withdrawn 2 |
| Trial Withdrawn 1 | Other | Other: Trial Withdrawn 1Trial Withdrawn 1 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults who are 21 - 55 years of age.
- Either 1) Moderate-to-heavy drinkers who drink on average more than 14 but less than 28 drinks per week; OR 2) adults who normally abstain from drinking alcohol.
Key exclusion criteria (4 listed)
- Participants who are currently taking prescription medications (including oral contraceptives)
- Pregnancy
- Body mass index (BMI) greater than 30
- History of seizures or eating disorders
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 |
|---|---|---|
| Trial Withdrawn 1Trial Withdrawn 1 | Other | Trial Withdrawn 1 |
| Trial Withdrawn 2Trial Withdrawn 2 | Other | Trial Withdrawn 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Background: PubMed 10997936Hesse LM, Venkatakrishnan K, Court MH, von Moltke LL, Duan SX, Shader RI, Greenblatt DJ. CYP2B6 mediates the in vitro hydroxylation of bupropion: potential drug interactions with other antidepressants. Drug Metab Dispos. 2000 Oct;28(10):1176-83.
- Background: PubMed 15083067Hesse LM, He P, Krishnaswamy S, Hao Q, Hogan K, von Moltke LL, Greenblatt DJ, Court MH. Pharmacogenetic determinants of interindividual variability in bupropion hydroxylation by cytochrome P450 2B6 in human liver microsomes. Pharmacogenetics. 2004 Apr;14(4):225-38. doi: 10.1097/00008571-200404000-00002.
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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.
David J. Greenblatt, MD principal investigator
Tufts University; Chair of Department of Pharmacology and Experimental Therapeutics, Sackler School
Michael H. Court, BVsc, PhD principal investigator
Tufts University, Department of Pharmacology and Experimental Therapeutics, Sackler School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trial Withdrawn 1 and Trial Withdrawn 2 in people with Alcohol Drinking and Depression, run by Tufts University 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 4 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: withdrawn, as of the sponsor's last update on 10 Nov 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330434, which also lists 2 linked publications.
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 10 Nov 2020.